5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks

5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks

Gestational Diabetes

Fibre supplement to be taken with each meal

Guar gum

Placebo. Fibre supplement to be taken with each meal

Cellulose

Imperial College NHS Trust

Effect of Fibre Supplements on Gestational Diabetes

The Use of Soluble Fibre for the Prevention of Gestational Diabetes Among High-risk Women. A Pilot Study.

An Oral glucose tolerance test will be performed. Gestational diabetes will be diagnosed if fasting plasma glucose >=5.3 and or 120 min plasma glucose >=7.8

Insulin sensitivity will be calculated using the Matsuda index

Insulin secretion will be assessed by the second-void fasting urinary C-peptide (as validated by McDonald et al).

Glycemic control, in women with early gestational diabetes, will be assessed by use of insulin (yes/no), in women who require insulin days to insulin and total insulin dose will be documented.

Imperial College London

Subjects receive usual care for pregnancy and postpartum.

Dietary counseling before 16 weeks of pregnancy Maintain food diary during pregnancy

Obesity

Pregnancy

The dietary intervention will be conducted by a registered dietician once. The dietary guidelines for study participants will be similar to those for gestational diabetes including 18 to 24 kcal/kg diet with 40% carbohydrates, 30% protein, 30% fat. No participant will be given a diet that is less than 2,000 kcal per day. Study subjects will record a food diary and to bring it to prenatal visits. Study subjects will limit intake of high calorie dense and acellular processed foods to 1-2 times per week if at all and to increase total percentage of fruits and vegetables to 5-9 items per day.

Dietary counseling. Maintain a food diary.

Truman Medical Center

Saint Luke's Hospital

CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

CO-OP Trial: Community-based Outreach on Obesity in Pregnancy: Using Community-based Participatory Research to Modify Dietary Interventions to Prevent Excessive Weight Gain During Pregnancy in Obese and Under-resourced Women

Primary outcome
1. Does the optimized dietary intervention for obese, urban and under-resourced women prevent excessive maternal weight gain as measured in kilograms from enrollment prior to 16 weeks to the final measurement before delivery?

Are the rates of complications (diabetes, hypertension, fetal macrosomia, intrauterine growth restriction, cesarean section, birth injury, shoulder dystocia) different between the study group and the control group?

Are birth weights comparable between the groups? How about the proportion of large for gestational age infants and small for gestational age infants?

Are leptin levels improved in the study group and how do the leptin levels compare between groups in the 3rd trimester to determine success of dietary intervention?

Do food frequency questionnaires correlate with total maternal weight gain or postpartum weight in mothers or infants? Is this different between the dietary intervention and control groups?

Is infant birth weight correlated with total gestational weight gain?

Does prevention of excessive maternal weight gain prevent infant obesity at 6 or 12 months?

What is food diary compliance in intervention group? (times brought to visits)

What are perceived barriers observed by participants to healthful eating?

Does dietary intervention alter quality of life in 3rd trimester or 12 months postpartum?

stillbirth/carbohydrate

Effect of Fibre Supplements on Gestational Diabetes

CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

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