Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes

Study Overview
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Brief Summary
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Study is an interventional clinical trial. Pregnant women (aged 25-40 years) diagnosed with GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan. A sample of 180 pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60 women who are treated with metformin, 60 women who are treated with insulin), who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary intervention, and control dietary intervention.

Detailed Description
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The main objective of this study is to compare the effect of carbohydrate counting, carbohydrate counting and DASH diet dietary interventions and a general dietary intervention on glycemic control, maternal and neonatal outcomes among Jordanian pregnant women with GDM. Eligibility criteria to be enrolled in the study will be being Jordanian pregnant women with GDM at 24 -28 gestational weeks, aged between 25 to 40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose, or chronic diseases and singleton gestation. DASH diet; and the third group will follow the diet prescribed by the hospital for GDM. The duration of intervention will extend from 24-28 gestational weeks until delivery, which will be usually 12-14 weeks later. The glycemic controls outcomes are testing fasting blood glucose, HbA1C, insulin and fructosamine at baseline and at end of intervention for three dietary interventions. While maternal outcomes are total maternal weight gain (kg), need for emergency caesarean section, the presence or absence of pregnancy-induced hypertension and preeclampsia. The new born birth weight, length and head circumference, the presence or absence of hypoglycemia and shoulder dystocia are the newborn outcomes.

Official Title
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Studying the Effectiveness of Carbohydrate Counting and Dietary Approach to Stop Hypertension Dietary Intervention on Glycemic Control and Maternal and Newborn Health Outcomes Among Jordanian Pregnant Women With Gestational Diabetes

Conditions
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Gestational Diabetes Mellitus With Baby Delivered

Intervention / Treatment
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* Behavioral: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Jordanian pregnant women with GDM at 24 -28 gestational weeks. Aged 25-40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose (Koivusalo et al., 2016). Singleton gestation (Louie et al., 2011). Absence of chronic diseases such as hypertension, hepatic and kidney disease and cancer, and psychiatric disorder (Ma et al., 2014). Absence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016) Pregnant women who do not have special dietary requirements (Louie et al., 2011). Nonsmoker or nonalcoholic drinker during pregnancy (Louie et al., 2011) Well educated and well cooperative, more than 10 years of formal schooling (Ma et al., 2014). Exclusion Criteria: Non- Jordanian pregnant women or Jordanian pregnant women with GDM at <24 or >28 gestational weeks. Aged > 40 years with multiple gestation and suspected over-diabetes (Koivusalo et al., 2016). Multiple gestations (Louie et al., 2011). Presence of chronic diseases, severe psychiatric disorder. Women with the risk factors for placental insufficiency, or history of preeclampsia (Ma et al., 2014; Koivusalo et al., 2016). Presence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016) Pregnant women who have special dietary requirements (Louie et al., 2011). Who smoked or consumed alcohol during pregnancy (Louie et al., 2011) Less than 10 years of formal schooling or previous intensive nutrition education or intervention for diabetes (Ma et al., 2014).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention CHO counting<br>Carbohydrate counting diet will be prepared according to Kulkarni, (2005). Tailored diet plans according to patient's food preference, physical activity level and appropriate insulin: Carbohydrates ratio will be prescribed for each participants. Diets were based on each participants's recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) (Thomas and Gutierrez, 2005; Kleinwechter et al., 2014). Energy requirement will be determined in the participants' pre-pregnancy weight with adding the extra requirement (450 kcal) due to pregnancy. The carbohydrate counts will be distributed into three main meals and 3 snacks. | Behavioral: Dietary Intervention<br>* Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.<br>* Other names: diet therpy;|
| Experimental: Dietary intervention CHO Counting & DASH<br>The recommended intakes of energy, protein (15-25%), fat (30-40%) and carbohydrate (40-50%) will be similar to that in carbohydrate counting diet which mentioned above. DASH diet food choices will be inserted in the diet of the participants assigned for the combined diet of DASH and carbohydrate counting. The emphasis will be more on the fruits and vegetables group (>8 servings/day), whole grains (at least half of the amount of the total servings of cereals; 6-8 servings/day), fat free dairy products (2-3 servings/day), lean meat and plant proteins (0-2 servings/day) and nuts (5-7 servings/week). From the fat group olive oil will represent the main type of fat (20-25% of total fat %). Adequate intake of sodium (2000mg) will be applied into participants' diet. | Behavioral: Dietary Intervention<br>* Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.<br>* Other names: diet therpy;|
| No Intervention: General Dietary guidlines<br>the general dietary advice and diet that will be prescribed by hospital for participants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c level | Hemoglobin A1c% at both baseline and endline of intervention | one year | 
| Fasting insulin level | Fasting insulin level in µIU/mL at both baseline and endline of intervention. | one year | 
| Fructosamine level | fructosamine in µmol/L at both baseline and endline of intervention. | one year | 
| Total maternal weight gain | Total maternal weight gain during pregnancy in kilograms | one year | 
| Weekly weight gain | weight in kilogram will be measured weekly for all participants | one year | 
| Insulin Therapy | Number of participants who need insulin therapy to normalize blood sugar. | one year | 
| Emergency caesarean section | Number of participants who need for emergency caesarean section versus vaginal delivery. | one year | 
| Pregnancy-induced hypertension | Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions). | one year | 
| Newborn weight | The newborn weight in grams | one year | 
| Newborn Length | The new born length in centimeters. | one year | 
| Newborn head circumference | The newborn head circumference in centimeters. | one year | 
| Hypoglycemic | Number of newborn babies who will suffer from hypoglycemia | one year | 
| Shoulder dystocia | Number of newborn babies with shoulder dystocia. | one year |