Preventing Excessive Gestational Weight Gain in Obese Women

Study Overview
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Brief Summary
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The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Official Title
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Preventing Excessive Gestational Weight Gain in Obese Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Over 18 years old < 16 weeks gestation BMI >= 25 Willing to consent Exclusion Criteria: Pregnant with Twins Untreated medical or psychological problem Inability to be physically active

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br> | |
| Experimental: Lifestyle intervention<br> | Behavioral: Lifestyle intervention<br>* The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain Per Week of Observation | Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used. | 13 weeks gestation, 35 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Offspring Weight Gain | Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age. | 1 week, 6 months, 12 months | 
| Kcals/Day | Changes in maternal calorie intake (Kcal/day) | 13 weeks gestation, 34 weeks gestation | 
| Changes in Offspring Dietary Intake | Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day). | 1 week, 6 months, 12 months | 
| Changes in Maternal Glucose | Fasting glucose | 13 weeks gestation, 34 weeks gestation | 
| Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group. | Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity. | 13 weeks, 40 weeks | 
| Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group | Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight. | 48-56 weeks post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obese, Pregnancy, Weight Gain