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

University of Jordan180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 40 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

Hemoglobin A1c level

Hemoglobin A1c% at both baseline and endline of intervention

Time frame: one year

Fasting insulin level

Fasting insulin level in µIU/mL at both baseline and endline of intervention.

Time frame: one year

Fructosamine level

fructosamine in µmol/L at both baseline and endline of intervention.

Time frame: one year

Total maternal weight gain

Total maternal weight gain during pregnancy in kilograms

Time frame: one year

Weekly weight gain

weight in kilogram will be measured weekly for all participants

Time frame: one year

Insulin Therapy

Number of participants who need insulin therapy to normalize blood sugar.

Time frame: one year

Emergency caesarean section

Number of participants who need for emergency caesarean section versus vaginal delivery.

Time frame: 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).

Time frame: one year

Newborn weight

The newborn weight in grams

Time frame: one year

Newborn Length

The new born length in centimeters.

Time frame: one year

Newborn head circumference

The newborn head circumference in centimeters.

Time frame: one year

Hypoglycemic

Number of newborn babies who will suffer from hypoglycemia

Time frame: one year

Shoulder dystocia

Number of newborn babies with shoulder dystocia.

Time frame: one year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts