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OpenTrials
Completed

NCT Number: NCT02233673

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 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Financial Incentives

Behavioral

Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.

Primary outcomes

  1. Gestational weight gain within the Institute of Medicine guidelines

    Time frame: At time of delivery

    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.

Secondary outcomes

  1. Cesarean delivery rate

    Time frame: Time of delivery

    Cesarean delivery rate (as a percent of total deliveries) will be assessed

  2. Fetal macrosomia

    Time frame: At delivery

    Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.

Other outcomes

  1. Cost of intervention

    Time frame: Intake to 6 weeks postpartum

    Costs to the patient attending the intervention (transportation, childcare, missed wages) will be calculated against cost differences in outcomes.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2014
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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