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CompletedNCT02233673Updated Oct 15, 2018

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

An interventional study of Financial incentives in Overweight, Obesity and Pregnancy, sponsored by University of Vermont. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by University of Vermont · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

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 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.

02

Conditions studied

  • Overweight
  • Obesity
  • Pregnancy

Keywords

  • Obesity
  • Pregnancy
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In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 136 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Behavioral, incentives

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

    Behavioral: Financial incentives

  • No intervention
    Standard care

    Participants receive standard obstetrical care from their provider

Interventions

  • BehavioralFinancial incentives

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At time of delivery

Secondary outcomes

  1. Cesarean delivery rate

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

    Time frame: Time of delivery

  2. Fetal macrosomia

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

    Time frame: At delivery

Other outcomes

  1. Cost of intervention

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

    Time frame: Intake to 6 weeks postpartum

07

Study locations

1 site
  • University of Vermont
    Burlington, Vermont 05401, United States
08

References and documents

Publications

  • Phillips JK, Skelly JM, Roberts LM, Bernstein IM, Higgins ST. Combined financial incentives and behavioral weight management to enhance adherence with gestational weight gain guidelines: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 Mar;1(1):42-49. doi: 10.1016/j.ajogmf.2019.02.002. Epub 2019 Mar 5. PubMed 33319756 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02233673
Lead sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Julie Phillips (Project Director, University of Vermont) — Principal investigator
First posted
Sep 8, 2014
Start date
Mar 2014
Primary completion
Aug 28, 2017
Completion
Aug 28, 2017
Last update
Oct 15, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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