Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women

Study Overview
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Brief Summary
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Excessive weight gain during pregnancy, particularly in overweight and obese women, predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal health. With an inverse relationship between socioeconomic status and obesity, significant health disparities exist between obese and normal weight women. The Institute of Medicine (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid body mass index (BMI), to minimize pregnancy complications. However, these recommendations are based on cross sectional observational studies and neither the ideal method to achieve weight gain goals nor whether perinatal outcome is optimized with active management of weight gain is known. The investigators propose to investigate a behavioral incentive-based intervention to improve compliance with IOM weight gain recommendations during pregnancy in low-income overweight and obese women. The investigators will evaluate if 1) gestational weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain management during pregnancy improves perinatal outcomes. Two study groups will be compared in a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those receiving behavioral weight management counseling plus financial incentives for achieving weight gain goals. The main outcome measure will be the percentage of women gaining within the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include fetal growth and body composition changes, birth weight and the rate of cesarean delivery. The investigators hypothesize that 1) the behavioral intervention with incentives will result in greater compliance to IOM guidelines for gestational weight gain than standard care and 2) targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be examined. This intervention, if efficacious and cost-effective, has the potential to improve compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce health disparities.

Official Title
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Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women

Conditions
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Obesity, Overweight, Pregnancy

Intervention / Treatment
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* Behavioral: Financial incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -≥18 years of age and ≤ 45 years of age -≤16 weeks gestation BMI ≥25 Ultrasound documented viable singleton intrauterine pregnancy English speaking Planning to deliver at Fletcher Allen Health Care Willing to be randomized to one of the study groups Written informed consent Exclusion Criteria: Major fetal congenital or chromosomal anomaly Women with a restricted diet (i.e., celiac disease, prior bariatric surgery, Phenylketonuria, or other metabolic disorder)

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 |
| --- | --- |
| Experimental: Behavioral, incentives<br>Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals | Behavioral: Financial incentives<br>* Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.<br>|
| No Intervention: Standard care<br>Participants receive standard obstetrical care from their provider | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain within the Institute of Medicine guidelines | Total gestational weight gain at time of last prenatal visit. For participants in the intervention arm, gestational weight gain at 2 week intervals will also be assessed. | At time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery rate | Cesarean delivery rate (as a percent of total deliveries) will be assessed | Time of delivery | 
| Fetal macrosomia | Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed. | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Pregnancy