Gestational Diabetes Mellitus is one of the most common medical complications in pregnancy and affects an estimated 14 % of pregnancies or one in every seven births globally. [1].More than 21 million births are affected by maternal diabetes worldwide each year. Women with Gestational Diabetes Mellitus have a 30% increased risk of cesarean delivery and a 50% increased risk of gestational hypertension. Their offspring have a 70% increased risk of prematurity and are 30% more likely to be LGA. Gestational Diabetes Mellitus is strongly associated with future maternal type 2 diabetes. It’s evident that exposure to all forms of diabetes in pregnancy confers a higher risk of childhood adiposity, insulin resistance and adverse neuro-developmental outcome [2]. Risks of GDM include polyhydramnios, pre-eclampsia, prolonged labor, obstructed labor, caesarean section, uterine atony, postpartum haemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity, mortality. Fetal risks include spontaneous abortion, intra-uterine death, stillbirth, congenital malformation, shoulder dystocia, birth injuries, neonatal hypoglycaemia and infant respiratory distress syndrome. immediate and long-term clinical effects of GDM are important contributors to the burden of non-communicable diseases in many countries. In GDM, it is necessary to develop an individual nutritional plan based on glycemic self-control, optimal weight gain based on pre-pregnancy BMI, and a calculation of energy requirements and macronutrient proportions, as well as taking into account the mother’s nutritional preferences, together with work, rest and exercise [3]. Another study indicated better results when using individualized recommendations for a specific woman with GDM in contrast to general recommendations [4]. It is recommended to eat three main meals and 2–3 snacks a day, often with a snack around 9:30 pm to protect against nocturnal hypoglycemia and morning ketosis [5]. In women with GDM, carbohydrates are the most important macronutrient, and their high consumption can cause hyperglycemia. However, glucose is the main energy substrate of the placenta and fetus, and thus, is necessary for their proper growth and metabolism [6]. According to the American Diabetes Association (ADA),the content of carbohydrates in the diet should constitute 40–50% of the energy requirement, not less than 180 g/day, and consist mainly of starchy foods with a low glycemic index (GI) [5, 3]. The recommended dietary fiber intake is 25–28 g/day, which means a portion of about 600 g of fruit and vegetables per day with a minimum of 300 g of vegetables, whole grain bread, pasta and rice [3, 7 and 8]. Increased intakes of plant protein, lean meat and fish, and reduced intakes of red and processed meats are beneficial in the treatment of GDM and may improve insulin sensitivity [9, 10]. A diet with a high fat content is contraindicated (20–30% of the caloric value is recommended, including < 10% saturated fat), as it leads to placental dysfunction and infant obesity, increased inflammation and oxidative stress, and impaired maternal muscle glucose uptake [10-12]. In view of above research studies, nutritional interventions are considered the most important treatment for Gestational Diabetes Mellitus. The current study was carried out to improve the nutrition and health status of pregnant women with Gestational Diabetes Mellitus as well as to mitigate further complications of both mother and infant with the following objectives. Objectives • Formative research to collect the baseline data with regard to the demographic, socio economic status, personal and family medical history of the pregnant women. • Nutritional status assessment with special reference to Gestational Diabetes Mellitus. • Design and development of a Nutrition Intervention on Gestational Diabetes Mellitus. • Implementation of a Nutrition Intervention to improve maternal and fetal health. • Impact evaluation of a Nutrition Intervention on maternal health, nutritional status and perinatal outcomes.

The present study is a hospital-based case control prospective observational study, which was carried out in Government maternity hospital, Tirupati for a period of one year (July 2023-July 2024). This study was undertaken after obtaining approval by the Institutional Ethics committee in SV Medical College, Tirupati Lr.No.156/2023,dated 02.08.2023 Women aged 18-40years, diagnosed with GDM were included. Women visiting the antenatal clinic of Government Maternity hospital, Tirupati included. Patients who gave consent out of their free will for participation were included for the research. Women willing to participate and follow the dietary regimen were included. Exclusion Criteria including women with Multiple pregnancy and/or congenital abnormalities, Pre pregnancy hypertension, Renal disease, HIV, Hepatitis B or C, Cardiac disease, any Auto immune diseases and under medication such glucocorticoids that affect blood glucose values were excluded for study.After excluding criteria, women (n=524) were included into the study as Intervention Group (n=262) and control Group (n=262). Research Design: Fig 1: Research Design Structured questionnaires were used as the tools for the preliminary data collection (Fig.1). The demographic and socio-economic status profile carries information such as age, educational qualification, occupation, family type, family income etc, These details were collected from women through administering a structured interview schedule. Each parameter was grouped into various categories and scores were given for each category respectively. Gestational data such as type of Gravida, trimester of Pregnancy, Pregnancy induced problems, month of diagnosis of GDM, how often the women visited the hospital, if they are on any ongoing medication, any drug allergies etc, were collected and recorded.Family histories of diabetes from all the subjects were recorded. Those with at least one close relative such as Grandfather, Grandmother, father, mother, brother or sister with Diabetes mellitus are considered as having positive family history. Height and weight of the samples were taken. Based on the data BMI was calculated using Quetelet index. A detailed diet history was recorded. In quantitative enquiry, exact amounts of foods and beverages consumed in terms of grams or liters (ml) were assessed and their nutrient contents were estimated. Comparisons of nutrient intakes with the Recommended Dietary Allowances (RDA) provide a measure of adequacy or inadequacy of food/nutrient consumption. Food and dietary information of the subjects in the current study was assessed using 24 hour recall method. Individual’s 24-hour food intake by recall during their initial visit and again at the end of the 3rd trimester on their regular ANC visit. The reference day for recall on food intake was the preceding day of the interview day. From the data, intake of food was calculated in the form of calories, carbohydrate, protein, fat, fiber, calcium, iron, β carotene and vitamin C, using Indian food composition tables- [13]. The biochemical assessment was carried out with regard to blood glucose, lipid profiles and Hemoglobin using standard procedures and protocols. Blood sample collection: After institutional ethical clearance and prior consent from participants, 5ml of blood was collected, serum was separated by centrifugation in REMI M8, and serum was stored at -80°C at MRU for analysis of FBS,PPBS,HbA1c ,Lipid profile and analyzed using Biosystems A25(Spain). The Blood Pressure of all the respondents was recorded. Lifestyle and diabetes are interlinked and is often termed as life style disease. Data pertaining to the lifestyle pattern of the samples was collected with regards to their physical activity in terms of exercise (walking, yoga, and meditation), personal habits such as coffee/Tea consumption etc. The nutrition intervention was implemented with individualized diet and nutrition counseling in intervention group. The women in control group were received the regular antenatal care from the hospital staff. The nutrition intervention designed and implemented is presented in the following sub heads. There are no particular guidelines for gestational diabetes till now; hence the designed diet chart was based on guidelines that are referred for diabetes and requirements of pregnant women, which include factors like age, sex, physical activity, height, weight, body mass index (BMI) and cultural factors. The diet was individualized, close to the family pattern, flexible and meal timing was planned according to the GDM status. Nutrition and Diet Awareness Programme on GDM was conducted (Fig.2 a,b,c, Fig.3). Diet charts, Poster and charts, Recipes, rich sources of protein, iron, calcium, antioxidants, and fiber and complex carbohydrates were displayed. Locally available foods were displayed based on the glycemic load and glycemic index of the foods and explained them in simple manner for better understanding and implementation Healthy plate with balanced diet for pregnant women was also displayed. Diet counseling was given to the pregnant woman, and also counseled them about the importance of healthy nutrient intakes and including 30-45 min of simple exercises. The importance of controlling body weight in reducing risks related to diabetes is also explained. We suggested them to include few yoga asanas, recommended exercises, and aerobic exercises are included in the designed manual. Statistical analysis The statistical program of SPSS version.21 was applied to test the statistical constants and accordingly the results were tabulated. Means and standard deviations were calculated for all the scores obtained by each of the select schedules for different components (variables). The difference between both Experimental and Control groups in relation to select indicators of nutritional status – anthropometry, dietary and health profiles were calculated by applying‘t’ test. Analysis of paired t-test was employed to test the levels of significant difference among different parameters. Fig.2 (a, b, c): Diet counseling during Nutrition Awareness programme Fig.3: Nutrition and Diet awareness programme on GDM

1. Socio-Demographic Data Gestational Diabetes mellitus (GDM) is a worldwide public health problem. It is a global crisis that threatens the health of young women in reproductive age regardless of socioeconomic status and geographic location. A total of 262 women in each intervention and Control group were included in the study, their age ranged between 18-40 years. Among the subjects in both groups i.e., Intervention group and Control group, maximum number (58.01% & 61.45% respectively) belonged to the age group of 18-24 years while 33.59% belonged to the age group 25-30 years. It was observed that in both groups, a very small number belonged to the age group i.e., 31-35 years (8.02% & 4.58% respectively) and 36 – 40 years (0.38%). Demographic and Socio-economic profile of the selected pregnant women are presented in Table 1. Table 1: Demographic and socio-economic profile of the sample Demographic and socio-economic profile Intervention group Control group Significance N % N % 0.447495NS Age (Years) 18-24 152 58.01 161 61.45 25-30 88 33.59 88 33.59 31-35 21 8.02 12 4.58 36-40 1 0.38 1 0.38 Locality Rural 132 50.38 134 51.15 0.204833 NS Urban 130 49.62 128 48.85 Education Primary School 75 28.63 72 27.48 0.483092 NS Secondary School 146 55.73 149 56.87 B.Sc/M.Sc/Higher.edu 32 12.21 32 12.21 Illiterate 9 3.44 9 3.44 Occupation Employee 3 1.15 3 1.15 0.484474 NS Student 22 8.40 25 9.54 Daily labour 15 5.73 16 6.11 Home maker 222 84.73 218 83.26 Family Type Joint 58 22.13 70 26.71 0.443375 NS Nuclear 204 77.86 192 73.28 Family Income (₹) 25,000-35,000 86 32.82 80 30.53 0.475521 NS 45,000-50,000 108 41.22 110 41.98 55,000-60,000 42 16.03 43 16.41 60.000 and above 26 9.92 29 11.07 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. Among the subjects, about 50.38 & 51.15% of the women in intervention group and control group respectively are living in rural areas while 49.62 & 48.85% are living in urban areas. The level of education varied widely among the subjects in both groups, women who pursued their secondary school education were more in this study group (55.73 & 56.87% respectively) while a very few women were in the grade of illiterate i.e., 3.44% in intervention group as well in control group. Education level of the subjects in this study was better which is most likely contributing to a better outcome of pregnancy in this study.The subjects exhibited diversified occupational patterns. Majority of the subjects were homemakers in both groups (84.73 & 83.26% respectively), and very few percent of the women were working and students in both Intervention and Control groups. It was observed that the majority of the families about 77.86% in intervention group and 73.28% in control group are belonged to the nuclear family while 22.13 & 26.71% respectively were belonged to the joint families. Majority of the subjects were falling in the income range of Rs. 45,000-50,000 and only 9.92 & 11.07% were in the category of Rs. 60,000 and above in both Intervention and Control groups. It was observed that, majority of the subjects were belonging to low and medium socio-economic status. It is a known fact that socio economic status is a factor which influences the outcome of pregnancy to a greater extent, affecting the nutritional status of the subjects. The data in table 1 represents the demographic and Socio-economic profile of the sample in both intervention and control groups were similar and there is no significant difference observed statistically. 2. Gestational data The data regarding Gestational details of the pregnant women was collected and presented in table 2. An appraisal of physiological events affecting the gestational performance viz, Type of Gravida, Trimester of the pregnancy, pregnancy induce problems, Month of diagnosis of GDM, Family history of diabetes, how often she visits the hospital, if she was on any ongoing medication, any drug allergies etc. were presented. Table 2: Gestational details of the sample Gestational Details Intervention group Control group Significance N % N % Type of Gravida 1st Pregnancy G1 115 43.89 127 48.47 0.496833 NS 2nd Pregnancy G2 108 41.22 92 35.11 3rd Pregnancy G3 30 11.45 36 13.74 4thPregnancy G4 9 3.43 7 2.67 Trimester 1st trimester 206 78.62 215 82.06 0.462963 NS 2nd trimester 40 15.27 36 13.74 3rd trimester 16 6.11 11 4.19 Pregnancy Induced Problems Yes 37 14.12 42 16.03 1.000000 NS Month of diagnosis 1sttrimester 205 78.24 194 74.04 0.411797 NS 2ndtrimester 40 15.27 47 17.93 3rdtrimester 17 6.48 21 8.01 How often visits hospital Once in 3 months 24 9.16 27 10.31 0.490728 NS Every month 238 90.84 235 89.69 If any ongoing medication Yes 23 8.78 41 15.65 1.000000 NS Any drug allergy Yes 12 4.58 19 7.25 1.000000 NS ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS- Not Significant. Among the subjects majority were primi gravidae and only few were multiparous with two and more pregnancies. Majority of subjects in Intervention and control groups (43.89 &48.47% respectively) are primigravida and 41.22 & 35.11% were in 2nd pregnancy. A very few women are in third and fourth pregnancy in both Intervention and Control groups. The majority of the women in both intervention (78.62%) and control group (82.06%) were in the 1st trimester of the pregnancy. A very few women were in the 3rd trimester of their pregnancy which was about 6.11 & 4.19% in Intervention and control groups respectively. Majority of Intervention group (85.88%) and Control group (83.97%) women does not have any pregnancy induced problems while 14.12 % of Intervention group and 16.03% of control group suffered with pregnancy induced problems. Among the subjects, 78.24% of Intervention group and 74.04% of Control group were diagnosed to have GDM in the 1st trimester itself while a very few about 6.48 & 8.01% of both groups were diagnosed in the 3rd trimester of their pregnancy. Majority subjects of both intervention (90.84%) and control group (89.69%) revealed that they visited the hospital every month while only very few of them visited the hospital once in 3 months. In Both Intervention and Control groups, about 91.22 & 84.35% of women were not taking any medication during baseline data collection while 8.78 & 15.65% of women in both groups revealed that they are under medication. Majority of subjects were not having any drug allergy in both Intervention and Control groups (95.42 & 92.75% respectively) while a very few women of both groups were having drug allergy (4.58 & 7.25% respectively). 3. Family Diabetic History Based on scientific reports it has been validated that diabetes within the communities is associated with the family history. The human ethnic classification and genetics plays a crucial role in progression of diabetes mellitus within the families. In this perspective, it is essential to examine family history of diabetes and hence in the present study enrolled participants were asked to provide details of family history. Table 3: Family history of diabetes in the sample Family History Intervention group Control group Significance N % N % Family history of diabetes- Yes 237 90.46 221 84.35 0.513794 NS No 25 9.54 41 15.65 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. In the present study, positive family history of T2DM was associated with gestational diabetes mellitus incidence. Majority of the women both in Intervention group (90.46%) and Control group (84.35%) were having family history of diabetes. 4. Health and Morbidity Status The data in the table - 4clearly shows that only very few women (less than 10%) are reported that they are suffering with hypertension (1.91 & 2.67%), Thyroid (8.40% and 7.25%), Pre diabetes (1.53% & 0.76%), and PCOD/PCOS (8.78 & 10.69 %) in both Intervention and Control groups respectively. Table 4: Health and morbidity status of the sample Health and morbidity status Intervention group Control group Significance N % N % Medical history - Hypertension Yes 5 1.91 7 2.67 0.446248 NS Thyroid Yes 22 8.40 19 7.25 Pre-diabetes Yes 4 1.53 2 0.76 Pcod / Pcos Yes 23 8.78 28 10.69 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. Morbidity refers to the condition of suffering from a disease and medical condition in an individual. Morbidity during pregnancy affects the health of the mothers and also the growth and development of the fetus. Hence, in the present study, morbidity status of the subjects was assessed. 5. Anthropometric Assessment The anthropometric status of pregnant women was recorded during first visit to the antenatal checkup. The pre-pregnancy anthropometric measurements of the women were also recorded during their first visit and compared with the standard values. The most commonly used measurements in anthropometry assessment are height and body weight. Body Mass Index (BMI) was assessed by using the Quetelet index formula. The data regarding anthropometric assessment of the respondents is presented in table 5 and fig.4. Table 5: Anthropometric assessment of the sample Parameters Intervention group Control group Significance N % N % Underweight (<18.5)kg 89 33.97 94 35.87 0.447018 NS Normal (18.5-24.9)kg 8 3.05 7 2.67 Overweight (25-29.9)kg 118 45.04 124 47.32 Obese I (30-34.9)kg 45 17.17 36 13.74 Obese II (35-39.9)kg 2 0.76 1 0.38 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant. Majority of the women’s body weight was higher than the normal range. Amongst the women, it was found that 45.04 and 47.32% were overweight in intervention and control groups respectively. 17.17% and 13.74% of intervention group and control group respectively were in obese grade I, only 0.76% in intervention group and 0.38% in control group are obese II. None of the women were in morbidly obese. It was observed that 33.97% of Intervention group and 35.87% of Control group women were underweight. Fig.4: Anthropometric assessment of intervention group (A) and control group (B) 6. Health Assessment Clinical Assessment, Signs and symptoms The women in the current study elicited a wide range of symptoms that differs from one patient to another with multiple complaints. The data of the signs and symptoms experienced by the women are presented in the table 6. Table 6: Clinical assessment of the sample Signs & Symptoms Intervention group Control group N % N % Significance Polyuria 202 77.1 226 86.3 0.374680 NS Polydipsia 117 44.7 127 48.5 Polyphagia 183 69.8 177 67.6 Pre-eclampsia 1 0.38 2 0.8 Blurred vision 8 3.1 1 0.4 Frequent infection 20 7.6 8 3.1 Fatigue/weakness 225 85.9 248 94.7 Nausea 33 12.6 46 17.6 Dizziness 5 1.9 2 0.8 Insomnia 33 12.6 31 11.8 No Symptoms 11 4.19 8 3.05 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. The signs and symptoms experienced by the GDM women of the current study. Among the sample about 80 % of the women experienced with one or more symptoms, and 20 % of the women were asymptomatic. Majority of the subjects in the study were suffering with multiple symptoms. 7. Biochemical Assessment Blood glucose profile In the current research the fasting blood glucose levels, postprandial glucose levels and HbA₁c of the subjects were presented in table 7. Table 7: Biochemical assessment of the sample Parameters Intervention group Control group Normal Range Significance Fbs (mg/dl) 107.68±21.855 107.63±21.883 95mg/dl 0.0620* Ppbs (mg/dl) 130.14±22.130 130.07±22.158 <120mg/dl 0.0330* HbA1c (%) 5.227±2.488 5.061±2.834 4-6% 0.0421* Hb (g/dl) 9.80±0.72 9.8±0.72 9.5-15g/dl 0.0214* Systolic pressure (mmHg) 110.36±11.09 110.36±11.09 ≤135 mmHg 0.0124* Diastolic Pressure(mmHg) 72.24±10.218 72.31±10.163 ≤85 mmHg 0.0327* Cholesterol(mg/dl) 211.32±53.406 213.31±52.345 141-200 mg/dl 0.0368* Triglycerides(mg/dl) 202.63±83.041 204.39±83.460 159 mg/dl 0.0217* ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. Table 7 shows that, the mean fasting blood glucose levels, post prandial glucose levels and HbA1c of the women in Intervention group were 107.68 % ±21.855%, 130.14% ±22.130% and 5.227% ±2.488% respectively. In the Control group women, fasting, post prandial glucose levels and HbA1c levels were 107.63% ±21.883%, 130.07% ±22.158% and 5.061% ±2.834% respectively. Majority of the subjects in both Intervention and Control groups were showed that their range of fasting blood glucose was in an exceed level. Similarly same observations were recorded for the post prandial blood glucose level. The HbA1c levels were also in the unsatisfactory range when compared with the normal levels of the diabetics in the study. Lipid profile of the sample Total cholesterol, triglycerides and systolic and diastolic blood pressure levels of gestational diabetic women were shown in Table 7 which shows that the subjects of the study had slightly abnormal levels of lipid profile. The systolic and diastolic blood pressure of intervention group women were 110.36±11.09mmHg and 72.24±10.218mmHg where as in control group women, the systolic and diastolic blood pressure was 110.36±11.09mmHg and 72.31±10.163mmHg respectively. The cholesterol values of the gestational diabetic women in the study are211.32±53.406mg/dl &213.31±52.345mg/dl in intervention and control groups respectively and were high compared to normal values. The triglyceride values are 202.63±83.041mg/dl &204.39±83.460mg/dl in interventional and control groups respectively was found higher compared to normal values. Haemoglobin Fig.5: Hemoglobin of samples It was observed from the data in table 7 and Fig.5 that the hemoglobin status was far below (9.8g/dl) among the sample in intervention and Control groups compared with the standard values. It was observed that a significant difference among the sample when compared with the normal values. The Hb values are very low in the current study. 8. Food and dietary assessment 24 hour recall method A healthy diet is a diet that helps to maintain or improve overall health. A healthy diet provides the body with essential nutrition with macronutrients, micronutrients and adequate calories. Dietary information is a measure of nutritional status. The data regarding nutrient intakes and their adequacy status were presented in table 8. Table 8: Dietary Assessment of the sample Nutrients Intervention group Control group RDA in GDM Significance Body Weight (kg) Energy (kcal) 2233.92 2285.04 1872 0.0453* Carbohydrates (g) 342 338 175 0.0150* Protein (g) 38.73 41.2 71 0.0109* Fat (g) 54.12 58.36 41.6 0.03385* Fiber (g) 18.29 17.42 30 0.01808* Folic acid (µg) 294 297 570 0.01265* Iron (mg) 11.34 13.56 27 0.02072* Zinc (mg) 8.23 9.12 14.5 0.02439* Calcium (mg) 544 570 1000 0.03171* Vitamin-C (mg) 47 51 80 0.00123* ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05), NS - Not Significant. The data in table 8 and Fig.6 shows that the nutrient intakes of diabetics of the current study during pre-intervention period. The energy (2233.92kcal &2285.04kcal), carbohydrate (342g &338g), fat (54.12g &58.36g) consumption of both Intervention group and Control group were high when compared to the RDA respectively. The data in the table clearly shows that there was a deficit in the intake of many nutrients which are significant to their health. The deficit was observed in the intakes of protein, fiber, folic acid, iron, zinc, calcium, iron and Vitamin C of both intervention and Control groups respectively. Fig.6: Dietary assessment of the sample 9. Food cravings The cravings towards many foods which are common during pregnancy were collected and the data was presented in Table 9 and Fig 7. Table 9: Food Cravings of the Subjects Foods Intervention group Control group Significance N % N % Pickles 218 83.20 214 81.67 0.349120NS Sweets 226 86.25 231 88.16 Spicy Food 139 53.05 142 54.19 Citrus Fruits 214 81.67 209 79.77 Junk food 203 77.48 203 77.48 Ice Cream 127 48.47 122 46.56 PICA 49 18.70 47 17.93 No cravings 48 18.32 51 19.46 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant. Fig.7: Food cravings of the subjects 10. Lifestyle assessment The lifestyle pattern of the diabetics in the current study was presented in Table 10. Table 10: Life style of the subjects Life style habits Intervention group Control group Significance N % N % Tea Yes 98 37.40 128 48.85 0.441364NS Coffee Yes 43 16.41 74 28.24 Milk Yes 250 95.42 250 95.42 Yes 250 95.42 250 95.42 None - 12 4.58 16 6.10 Physical activity - Walking Yes 205 78.24 192 73.28 0.487518 NS Household work Yes 262 100 262 100 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant. The data regarding tea/coffee consumption by the gestational diabetic women are presented in the Table 10. Majority of the subjects reported the habit of consumption of tea, coffee and milk daily. Among this, many subjects were preferred to have milk i.e., about 95.42 % respectively in both Intervention group and Control group. The habit of tea/coffee consumption was observed in 37.40&16.41% in Intervention group and 48.85&28.24 % of women in control group respectively. A more number of subjects were involved in activities like walking (78.24&73.28%) and household works (100% in both groups) during pregnancy. In fact, during pregnancy regular physical activity has benefitted in preventing obesity in women and better growth and development of the infant [14]. Exercise pattern/activity of the subjects in the Table 10 shows the percentage distribution of subjects with gestational diabetes mellitus according to their physical activity pattern. Majority of the subjects both Intervention group and Control groups (78.24&73.28%) were following daily exercise (walking) as their routine activity for maintaining their health whereas few others (21.75 & 26.71 %) were not performing any physical activity but all the women in both groups were involved in the household works. Nutrition intervention A low carbohydrate, low glycemic index, high fiber, adequate proteins, low fat food enriched with antioxidants used as a therapeutic supplement in the management of GDM in the current study. The baseline data results revealed that the Nutrient intakes were very negligible among the women. Medical nutrition therapy (MNT) plays an important role in the management of gestational diabetes mellitus (GDM), all pregnant women with GDM in intervention group was given Medical Nutrition Therapy (MNT) as soon as diagnosis is made. MNT should assure that food choices are well balanced and provide adequate levels of key nutrients for pregnancy. Diet and nutrition awareness Programme was organized. it represent a unique opportunity to provide the support materials such as posters, charts containing information about concept, Signs and symptoms, Diagnosis, consequences, diet and nutrition guidelines etc were displayed. Along with the support materials, the assortment of foods such as green leafy vegetables, sprouts, grains, jaggery, fruits and animal foods with respect to GDM were also arranged on the tables (Fig.8). In addition to reinforcing the placard materials, the actual foods were also helped to promote the messages. The Doctors from government maternity hospital and SV Medical College have explained about GDM and prevention and control measures of it. Diet counseling was given to the pregnant woman. The food science, Nutrition and Dietetics students and Research Scholars have given the diet counseling (Fig.8). Fig.8: Exhibition Gestational diabetes mellitus (GDM) among pregnant women increases the risk of both short-term and long-term complications, such as birth complications, babies large for gestational age (LGA), and type 2 diabetes in both mother and offspring. The diet recommended for women with GDM should contain sufficient macronutrients and micronutrients to support the growth of the foetus and, at the same time, limit postprandial glucose excursions and encourage appropriate maternal gestational weight gain. Blood glucose excursions and hyperglycaemic episodes depend on carbohydrate-intake. Further, physical activity has beneficial effects on glucose and insulin levels and it can contribute to a better glycaemic control. A glycaemic index (GI) system was developed based on the notion that certain carbohydrate-containing foods are more likely to cause postprandial increases in plasma glucose. The GI is a standardized system which assigns numerical values to foods based on their propensity to increase blood glucose. A low GI diet encourages the consumption of foods with a low GI score to reduce the impact of carbohydrate on glycemia, thereby managing diabetes and cardiovascular risk [15]. The meal plan composition The recommended composition of the diet for GDM positive mothers is 50% - 60% calories from carbohydrate, 10-20% from protein, 25-30% from fat. The distribution of calories, particularly carbohydrate, makes a difference in the postprandial blood sugars. The total intake of carbohydrate should be controlled and monitored and carbohydrate foods with a lower glycemic index should be emphasized a mixed meal consisting of carbohydrate, protein, fat, fiber eaten together results in slow blood sugar rise. One should include all food groups in her daily diet i.e cereal, pulses, milk and milk products, fruits, vegetable, and fats. For non-vegetarian mothers, eggs, low fat meat like well-cooked fish or chicken can be included. Meal plan should be divided in to 3 major meals (breakfast, lunch and dinner) and 2-3 mid-day snacks. Post interventions After nutrition intervention, clinical assessment, dietary assessment and maternal outcomes were analysed and the data obtained is presented in the following table and figures. Clinical Assessment The data pertaining to clinical signs and symptoms during pre and post interventions in intervention and Control groups are presented in the table 11. The data in table 11 clearly shows a positive decrease in trend in almost all clinical signs and symptoms in interventional group at the end of the study. This is due to the fact that, the improving dietary intakes and modifying the dietary patterns had a positive impact in reducing majority of the clinical signs and symptoms in intervention group. The whole credit goes to the nutritional intervention with special reference to individualized nutrition counseling with customized diet charts. It brings awareness among the target group which change their dietary behavior and good dietary intakes ultimately it shows a decreasing trend of clinical signs and symptoms. These findings clearly reflect the role of dietary interventions improve the health status of women with Gestational diabetes mellitus. Table 11: Clinical Assessment during Pre and Post Intervention Signs & Symptoms Intervention group Control group Pre test Post test Pre test Post test Significance N % N % N % N % Polyuria 202 77.1 189 72.1 226 86.3 219 83.6 0.0343* Polydipsia 117 44.7 107 40.8 127 48.5 122 46.6 0.0293* Polyphagia 183 69.8 179 68.3 177 67.6 173 66.0 0.0243* Pre-eclampsia 1 0.38 1 0.38 2 0.76 2 0.76 0.0356* Blurred vision 8 3.1 6 2.3 1 0.4 1 0.4 0.0373* Frequent infection 20 7.6 14 5.3 8 3.1 6 2.3 0.0244* Fatigue/weakness 225 85.9 215 82.1 248 94.7 242 92.4 0.0367* Nausea 33 12.6 27 10.3 46 17.6 40 15.3 0.0286* Dizziness 5 1.9 2 0.8 2 0.8 6 2.3 0.0248* Insomnia 33 12.6 28 10.7 31 11.8 37 14.1 0.0373* No Symptoms 11 4.19 11 4.19 8 3.05 8 3.05 0.0387* ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS- Not Significant. Dietary Assessment The table 12 shows the dietary assessment of both intervention and Control groups. The data in table shows that the nutrient intakes in terms of carbohydrate (342 to 236 g), protein (38.73 to 53.26g), fiber (18.29 to 23g), folic acid (294 to 420420), Iron (11.34 to 21mg), Zinc (8.23 to 11mg), Calcium (544 to 700 mg) and Vitamin C (47 to 69 mg) were significantly improved from pre and post intervention in intervention group. The fat intakes which were more than Recommended Dietary Allowances were significantly decreased from pre (54.12 g) to post intervention (42.12 g) respectively. Whereas the calorie intake in both intervention and Control groups were increased from pre (2233.92&2285.04K.cal) to post intervention (2384.73&2460.21K.cal). This may be due to the increased quantities of staple foods from 1st trimester to 3rd trimester. There is a slight increase in few nutrients among Control group women were observed. The reason might be the regular antenatal care given by the hospital staff along with self-care of the respondents. Table 12: Dietary assessment during pre and post intervention Nutrients Experimental Control RDA in GDM Significance Pre test Post test Pre test Post test Energy (Kcal) 2233.92 2384.73 2285.04 2460.21 1872 0.000* Carbohydrates (g) 342 236 338 351 175 0.000* Protein (g) 38.73 53.26 41.2 44.12 71 0.000* Fat (g) 54.12 42.12 58.36 56.26 41.6 0.000* Fiber (g) 18.29 23 17.42 18.24 30 0.000* Folic acid (µg) 294 420 297 354 570 0.000* Iron (mg) 11.34 21 13.56 16.12 27 0.000* Zinc (mg) 8.23 11 9.12 10.12 14.5 0.000* Calcium (mg) 544 700 570 620 1000 0.000* Vitamin-C (mg) 47 69 51 59 80 0.000* ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant Food Cravings Food cravings are common in pregnancy and along with emotional eating and eating in the absence of hunger, they are associated with excessive weight gain and adverse effects on metabolic health including gestational diabetes mellitus (GDM). Cravings commonly occur in pregnancy and contributed to a small increase in energy intake; however, this did not impact on overall dietary intake, nor was it associated with excessive gestational weight gain, maternal glycemic or offspring outcome measurements. The data in table 13 shows that, there is a significant reduction in almost all cravings in intervention group. The nutrition education and improvements in dietary nutrients might be a cause for the change in intervention group. Table 13: Food cravings during pre and post intervention Food Cravings Intervention group Control group Pre test Post test Pre test Post test Significance N % N % N % N % 0.357640 Pickles 218 83.20 198 75.57 214 81.67 216 82.44 Sweets 226 86.25 70 26.71 231 88.16 241 91.98 Spicy Food 139 53.05 121 46.18 142 54.19 147 56.10 Citrus Fruits 214 81.67 221 84.35 209 79.77 206 78.62 Junk food 203 77.48 38 14.50 203 77.48 196 74.80 Ice Cream 127 48.47 24 9.16 122 46.56 92 35.11 PICA 49 18.70 11 4.19 47 17.93 31 11.83 No Cravings 48 18.32 48 18.32 51 19.46 51 19.46 ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant. Maternal Outcomes The data with regard to the maternal and fetal outcomes are presented in the table 14. The data clearly shows that, there is a significant difference in many of the obstetric parameters between intervention and Control groups. It was observed from the data that 41.9% of women in intervention group had normal delivery whereas the normal delivery among Control group was 34.5% which was statistically significant. More than 50% of the sample in both intervention and control group had Lower Segment Cesarean Section. 5.34% of intervention group and 6.87% of control group had vaccum delivery and 1.90 and 3.81 % had outlet forceps in intervention and control group respectively. The women with UTI problems are observed more in Control group (19.84%) compared with intervention group (2.6%) which shows a significant difference. Vaginal Candidiasis observed in both groups but it was lower in intervention group i.e., 7.25% where as 24.04% in Control group. There was a significant difference observed in Preterm Labor which was about 5.72&1.14% in both intervention and Control groups. Polyhydramnios also showed statistically significant difference which was 3.05% in intervention group and 1.90% in Control group. The more women in Control group had Prolonged Labour (16.03%) compared to the women in intervention group (8.77%) respectively. Postpartum Haemorrhage was observed to be more in Control group about 10.30% when compared with the intervention group which was about only 3.43% respectively. The Puerperial Sepsis and lactation failure were similar in both intervention and Control groups. Among fetal outcomes about 5.34% babies from intervention group have shown the Apgar Score < 7 and 94.65 % babies from the same group have >7 Apgar score where as in control group 99.61% babies have >7 Apgar score. About 3.43 & 2.29 % from both intervention and Control groups have admitted for NICU Admission-RDS / Birth Asphyxia. Hypoglycemia was observed to be more in intervention group (2.67%) compared with Control group (1.1%). Majority of the babies have the weight between 3-3.4 kg in both intervention and Control groups (57.63&58.02%) respectively. Table 14: Maternal and fetal outcomes of the sample Parameters Intervention group Control group Significance Maternal Outcomes N % N % Type Of Delivery Normal 110 41.9 90 34.35 0.0000* Abnormal labor 0.0000* Vaccum delivery 14 5.34 18 6.87 Outlet forceps 05 1.90 10 3.81 LSCS 133 50.76 144 54.96 UTI Infection 07 2.6 52 19.84 0.0000* Vaginal Candidiasis 19 7.25 63 24.04 0.0000* Preterm Labour 15 5.72 03 1.14 0.0000* Polyhydramnios 08 3.05 05 1.90 0.0000* Prolonged Labour 23 8.77 42 16.03 0.0000* Postpartum Haemorrhage 09 3.43 27 10.30 0.0000* Puerperial Sepsis 03 1.14 03 1.14 NS Lactation Failure 02 0.76 2 0.76 NS Fetal Outcomes Apgar Score- <7 14 5.34 1 0.38 0.0000* >7 248 94.65 261 99.61 0.0000* NICU Admission-RDS / Birth Asphyxia 09 3.43 06 2.29 0.0000* Hypoglycemia 07 2.67 03 1.1 0.0000* Wt of the baby in kgs 2.5-2.9 kg 22 8.40 25 9.54 0.0001* 3-3.4 kg 151 57.63 152 58.02 0.0001* 3.5-4.0 kg 89 33.97 85 32.44 0.0001* ** Significant at 0.01 level (p<0.01) * Significant at 0.05 level (p<0.05)NS - Not Significant. The well designed and more structured nutrition intervention in the current study had a positive impact on health and nutritional status of GDM women.

Assessment of nutrition and health status during pre-intervention Pregnancy is a very critical period in woman’s life. Pregnancy outcomes also affect the health and manpower needs of societies, having implications for individuals, families, communities and society at large. There is a significant relationship between pregnancy outcomes and socio-cultural factors ranging from economic status of pregnant women and their spouses, occupation, level of education, income and reactions to cultural practices during pregnancy [16].Other factors that affect the outcome of pregnancy are age of the mother, pre pregnancy weight, dietary habits and the reproductive history of the women. Education: In the study [17] observed the prevalence of diabetes mellitus even influenced by education. However, in contrast to the above study, another study [18] revealed that there was no association between T2DM with education. Educational status is the integral part of determining pregnancy outcomes, low levels of education would lead to low birth weight infants and there is a higher incidence of maternal mortality. Women with higher education levels were more aware of diet-disease relationships [19]. Further, it was confirmed that there is an influence of education on the correct practices concerning to the dietary pattern and child rearing practices. Socio-economic status: Association between diabetes mellitus and socio-economic status was also observed by various authors in their studies. Higher socio-economic classes are associated with high calorie diet intake and sedentary lifestyle which lead to obesity and diabetes [20]. However, the mechanisms through which poor socioeconomic status and maternal risk factors contribute to the higher incidence of GDM have not been adequately investigated. There is evidence that GDM incidence increases along with the increase in living standards. At the same time, studies show that GDM incidence is inversely associated with socio-economic status within the population; women with high socioeconomic status have a lower risk of GDM than women with low socioeconomic status. Family history: In addition to being a risk factor for the disease, a family history of diabetes is also favorably correlated with risk awareness and risk-reducing activities. It might be a helpful screening tool for diabetes identification and prevention. In terms of overall diabetes prevalence, undiagnosed diabetes accounts for about 29.3% [21]. Co-morbidities: Anemia, low BMI and respiratory diseases are linked with poor nutritional status. Infections of the urinary tract, pregnancy induced hypertension and gestational diabetes are the common morbidity conditions during pregnancy [22]. Co-morbidities associated with Gestational Diabetes Mellitus have a long list and affect/regulate the disease. Prediabetes, Hypertension, Thyroid, PCOD/PCOS etc., are most common co-morbidities associated with the Gestational Diabetes Mellitus. These co-morbidities not only increase the risk of diabetes mellitus but also pose risk on damage of other organ systems. Body Mass index: Several studies reported that BMI as an independent risk factor for Diabetes Mellitus. The early identification of high BMI would be helpful for primary prevention and early diagnosis of diabetes. Women had a stronger predisposing to developing Diabetes Mellitus as they had more extensive fat distribution in the body. There is an increased rate of obesity in child bearing women, it is estimated that there are 38.9 million over weight and 14.6 million obese pregnant women worldwide [23]. For people who are overweight and obese, increased lipid production leads to the accumulation of lipids, mainly triglycerides in the adipose tissue and other organs such as liver. Hepatic insulin resistance is increased in obesity and is further exacerbated by pregnancy, thus increasing the risk of developing Gestational Diabetes Mellitus. Moreover, being overweight or obese during pregnancy can increase the risk of adverse consequences such as other associated disorders such as hypertension, premature delivery, and still birth as well as others [24]. For these reasons, Obstetricians and Dietitians regularly assess the BMI of pregnant women in order to prevent complications for both mother and child. These information and data will be helpful to design, prevention and treatment programmes to manage body weight during pregnancy which includes personalized nutrition therapy and improving dietary and lifestyle habits. Glucose levels: A study [25], reviewed previous studies of diurnal glycemic profiles and concluded that relative contribution of postprandial plasma glucose to HbA1c was high (70%) in patients with fairly good Control group of diabetes(HbA1c<7.3%) and decreased progressively (30%) with worsening diabetes (HbA1c>10.2%) whereas the contribution of fasting plasma glucose showed a gradual increase with increasing levels of HbA1c. Lipids: Many studies have shown altered lipid profile in diabetes mellitus, further causes to dyslipidemia leading the diabetic patients to cardiovascular complications. A prospective study [26] also suggests that a high LDL/HDL ratio combined with hypertriglyceridaemia is associated with highest chronic heart disease risk. Exercise patterns Physical activity includes all movements that increases energy use, whereas exercise is planned, structured physical activity. Physical activity is likely an effective intervention for prevention and treatment of GDM, given its known effectiveness in prevention and treatment of type 2 diabetes. Based on observational studies, physical activity initiated before and/or during pregnancy has a positive influence on maternal glucose and insulin metabolism and reduces the risk of GDM [27]. The study that directly demonstrates the effectiveness of diabetes prevention included changing the whole lifestyle of the patients with an individualized diet and closely monitored physical activity. The authors observed 269 high-risk pregnancies, divided into an intervention group (144 pregnancies) and a control group (125 pregnancies). During the study, the control group received standard medical care, whereas the intervention group took part in group sessions with dieticians, with personal, individualized education meetings on diet, weight, and physical activity by qualified staff. The examined intervention has reduced the risk of developing GDM in high-risk patients by 39%, with a probability of incidence of 13.9% in the intervention group and 21.6% in the Control group ((95% CI 0.40–0.98%) p = 0.044) [28].

Maternal health and nutritional status are the components that influence the health status during pregnancy and outcomes of pregnancy. These are the key components, in particular that affect the neonatal outcome and also impact the growth and development of the off springs. Maternal anthropometry, maternal age, educational status, nutritional status, hereditary predisposition, occupational status, physical activity status has an impact on the gestational performance and outcomes of pregnancy. Teenage pregnancies, anemia during pregnancy, diabetes and hypertension are termed as high-risk pregnancies are of great concern as they impose adverse impact on the outcome of pregnancy. Although these implications are very serious, when GDM is well managed, and blood glucose levels are kept within normal limits, most pregnancy complications can be avoided. Management generally involves monitoring of blood glucose levels and lifestyle modifications including dietary adjustments and physical activity. The seriousness of GDM and the dramatically increasing incidence of this condition make it one of the most urgent health challenges of this century. It is thus important to raise the public awareness of this condition and to ameliorate the harmful effects of GDM once diagnosed. In spite of this urgency, there is limited evidence of successful intervention studies for women with GDM, particularly among low socio-economic groups, and seemingly, no consistent approach to treating this condition. There is also recognized need for the development of health resources to educate, motivate and empower women to self-manage their GDM. An integrated nutrition intervention successfully improves health and nutritional status of both mother and infant. The current study also concluded that larger trials to assess effects of various diets for women with GDM on maternal and infant health outcomes are needed for future research. Hence the universal screening programme should be made available to all pregnant women which helps to detect the presence of disease. Acknowledgements We are grateful to Multidisciplinary Research Unit (MRU-DHR-ICMR, GOI) for funding the current research project. We are grateful to Dr. Kutty Kumar, Assistant Professor,Library and Information Science,University Library, Sri Venkateswara Veterinary University,Tirupatifor his support in statistical analysis. We extend our thanks to Dr. Jhansi Donadi, Faculty in food technology, Sri Venkateswara University, Tirupatifor her support in organizing Nutrition Intervention Programme. We are very grateful to All Pregnant Women involved in the current study. Authors' contribution 1. Study concept and design:Prof. Manjula Kola, Dr. K. Sunitha, & Dr. P. Madhusudana 2. Acquisition of data:Dr. K. Sunitha & Prof. Manjula Kola 3. Analysis and interpretation of data:Prof. Manjula Kola, Dr. K. Sunitha, & Dr. P. Madhusudana 4. Drafting of the manuscript:Prof. Manjula Kola & Dr. K. Sunitha 5. Critical revision of the manuscript for important intellectual content: All the Investigators 6. Statistical analysis: Dr. Kutty Kumar, Assistant Professor, Library and Information Science, Sri Venkateswara Veterinary University, Tirupati 7. Administrative, technical, and material support: MRU-DHR, Government Maternity Hospital, SV Medical College & Food Science Nutrition & Dietetics, Department of Home Science, Sri Venkateswara University, Tirupati 8. Study supervision: All the Investigators Disclosures Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following:

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