ClinicalTrials.Veeva

Menu

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

University of Vermont logo

University of Vermont

Status

Completed

Conditions

Overweight
Obesity
Pregnancy

Treatments

Behavioral: Financial incentives

Study type

Interventional

Funder types

Other
NIH

Identifiers

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

Behavioral, incentives
Experimental group
Description:
Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals
Treatment:
Behavioral: Financial incentives
Standard care
No Intervention group
Description:
Participants receive standard obstetrical care from their provider

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems