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NCT02233673 · ClinicalTrials.gov registry record · NA

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

A NA study of Obesity and Overweight, sponsored by University of Vermont.

Completed
Registry status
NA
Development phase
136
Enrollment target
1
Study location

NCT02233673 is a NA study of Obesity and Overweight that has completed, run by University of Vermont. The registered enrollment target is 136 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02233673, a NA study of Obesity and Overweight, has completed, sponsored by University of Vermont.

COMPLETED
Registry status
NA
Development phase
136 participants
Enrollment target
1
Study location

Study Summary

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 b

Interventions

  • BEHAVIORAL Financial incentives

Study Locations (1)

Vermont

  • University of Vermont - Burlington

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2014-03
Est. Completion 2017-08-28
Phase NA

Sponsor

University of Vermont

162 total trials

What the Registry Record Tells You About NCT02233673

The ClinicalTrials.gov registry entry for NCT02233673 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (83% lower). The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Financial incentives is the first listed.

NCT02233673 reports 1 study location spanning 1 distinct geographic area - top geographies include Vermont.

Frequently Asked Questions

What is clinical trial NCT02233673 about?

NCT02233673 is a clinical study titled "Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women". 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...

What is the current status of trial NCT02233673?

This trial is currently completed. It is a NA study. The enrollment target is 136 participants. The study started on 2014-03. Estimated completion is 2017-08-28.

What conditions does trial NCT02233673 study?

This clinical trial studies the following conditions: Obesity, Overweight, Pregnancy.

What interventions are being tested in trial NCT02233673?

The interventions under investigation include: Financial incentives (BEHAVIORAL).

Who is sponsoring clinical trial NCT02233673?

This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02233673 being conducted?

This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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