None listed
Conditions
Brief summary
To compare the effects of a low GI diet versus a wholegrain diet during pregnancy in reducing prevalence of large for gestational age infants in women at high risk for developing gestational diabetes. The study hypothesis is that infants born to high risk pregnant women who received low GI dietary advice will have a lower birth weight z-score and percentage body fat than those whose mothers received advice on a macronutrient-matched wholegrain diet.
Interventions
Low Glycemic Index (GI) diet, consisting of protein (15 – 25%), fat (30 – 35%) and carbohydrate (45 – 50%) content and a low dietary GI less than 50. Carbohydrate choices for the low GI diet will include pasta, low GI rice, low GI breakfast cereals and breads. The intervention duration is from 20 weeks gestation until birth. The intervention involves five consultations with an accredited practising dietitian (APD) at 20, 24, 28, 32 and 36 weeks of gestation. At weeks 20 and 36, the approximate d
Low Glycemic Index (GI) diet, consisting of protein (15 – 25%), fat (30 – 35%) and carbohydrate (45 – 50%) content and a low dietary GI less than 50. Carbohydrate choices for the low GI diet will include pasta, low GI rice, low GI breakfast cereals and breads. The intervention duration is from 20 weeks gestation until birth. The intervention involves five consultations with an accredited practising dietitian (APD) at 20, 24, 28, 32 and 36 weeks of gestation. At weeks 20 and 36, the approximate duration of each dietary education session is 60 minutes. At weeks 24, 28 and 32, the approximate duration of each dietary education session is 30 minutes. Handouts and recipes will be provided, and the participants will have access to the research dietitian via phone throughout their participation period. Participants will receive a food basket at each of the five education sessions with the dietitian (at week 20, 24, 28, 32 and 36 weeks of gestation) containing foods that are low GI to improve their compliance and understanding of the advised food choices.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant: between 14-20 weeks of gestation And one or more of the following GDM risk factors: 1. Age: > 30 years 2. Family history of type 2 diabetes- first-degree relatives with type 2 diabetes 3. Overweight or obese: Pre-pregnancy Body Mass Index (BMI) > 30 (Kg/m2) 4. Past history of GDM or glucose intolerance 5. History of ‘large for gestational age’ babies: Previous baby > 4kg 6. Belonging to a high-risk ethnic group: Aboriginal or Torres Strait Islander, Polynesian, Middle Eastern, Indian and Asian. 7. Ability to read and understand participant information and consent form 8. Ability to comply with the scheduled visits and dietary advice
Exclusion criteria
1. Pregnancy achieved by assisted reproduction 2. Smoking 3. Special dietary requirements (e.g. gluten intolerance, celiac disease) 4. Pre-existing type 1 or type 2 diabetes 5. GDM diagnosis <20weeks of gestation: Oral Glucose Tolerance Test (OGTT) showing high fasting greater than or equal to 5.8mmol/L & 2 hr Blood Glucose Level (BGL) reading greater than or equal to 11.1 mmol/L
Outcome results
None listed