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

NCT ID: NCT02233673

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-08-28

Brief 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.

Conditions

Overweight; Obesity; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Behavioral, incentives

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

Group Type: EXPERIMENTAL

Financial incentives

Intervention Type: BEHAVIORAL

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

Standard care

Participants receive standard obstetrical care from their provider

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Financial incentives

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Julie Phillips

Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33319756 (View on PubMed)

Other Identifiers

13-276

Identifier Type: -

Identifier Source: org_study_id