Interventions to Reduce Excess Weight Gain in Pregnancy

Study Overview
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Brief Summary
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The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.

Official Title
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Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers

Conditions
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Pregnancy, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Intervention to reduce excess weight gain during pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years In first trimester of pregnancy Must be willing to not join any other weight control program while in the study BMI of 25-40 kg/m2 Willingness and ability to attend support group meetings either in person or via web Must be able to read, speak, and understand English Exclusion Criteria: Carrying multiple fetuses Gestational diabetes mellitus at study entry Type 2 diabetes mellitus or blood glucose >125 mg/dl at screening Self reported current substance abuse Current smoking Alchol consumption of more than 1 drink per day Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing Eating disorder in the past 2 years Depression or diagnosis of bipolar disorder Concurrent participation in any other research study that would impact participation in this investigation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fiber Cereal<br>Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger. | Behavioral: Intervention to reduce excess weight gain during pregnancy<br>* Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.<br>|
| No Intervention: Control Group<br>Women assigned to this arm of the study will receive routine clinical care and no additional interventions. | |
| Active Comparator: Resistant Starch<br>Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger | Behavioral: Intervention to reduce excess weight gain during pregnancy<br>* Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and Infant Body Weight Change | Maternal non-fasting weight measured at all prenatal clinic and study visits. Infant weight measured at birth and all pediatric clinic visits through 1 year. | From first trimester through 1 year post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Outcomes | Body composition (i.e. length, head circumference, skinfold thickness, waist circumference) changes through the first year. Characteristics at birth including Apgar score, gestational age. Dietary intake and food preferences at 1 year. | From birth through first year | 
| Maternal and Perinatal Outcomes | Rates of cesarean delivery, gestational hypertension/preeclampsia, preterm birth, birth complications. Fasting blood glucose and insulin concentrations throughout pregnancy. Body composition and energy requirements at baseline and 24-28 weeks of pregnancy. Total energy expenditure at 24-28 weeks of pregnancy. Rate of breastfeeding and breastfeeding practices at 1, 3, 6, and 12 months post-partum. | First trimester through 1 year post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight, pregnancy, behavioral intervention, obesity