Appropriate Gestational Weight Gain in Overweight/Obese Women

Study Overview
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Brief Summary
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The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.

Official Title
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Appropriate Gestational Weight Gain in Overweight/Obese Women

Conditions
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Gestational Weight Gain

Intervention / Treatment
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* Behavioral: Lifestyle Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record) Exclusion Criteria: Diabetes Cardiovascular disease Gastrointestinal disease Bariatric surgery Lung disease Thyroid disease Eating disorder Cancer Bed rest or Gestational Diabetes in the current pregnancy Planning to get pregnant again or move within 1 year of delivery Substance abuse Serious mental health disorders

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy. | Behavioral: Lifestyle Intervention<br> <br> |
| Active Comparator: Usual Care<br>Usual Medical Care | Other: Usual Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gestational weight gain per week |  | From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy | 
| Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week |  | from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total gestational weight gain |  | from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks | 
| Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week |  | From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks | 
| Rate of gestational weight gain between study clinical assessments |  | Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week) | 
| Diet - total calories from fat |  | Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation | 
| Diet - proportion of calories from fat |  | Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation | 
| Physical Activity |  | Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 
| Metabolic marker - glycemia |  | Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 
| Metabolic marker - insulinemia |  | Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 
| Metabolic marker - lipids |  | Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 
| Metabolic marker - leptin |  | Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 
| Metabolic marker - adiponectin |  | Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational weight gain, Lifestyle, Intervention