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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Pregnancy
• Intervention / Treatment: Behavioral: Financial incentives

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral, incentives; Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals	Behavioral: Financial incentives; Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
No Intervention: Standard care; Participants receive standard obstetrical care from their provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean delivery rate	Cesarean delivery rate (as a percent of total deliveries) will be assessed	Time of delivery
Fetal macrosomia	Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.	At delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of intervention	Costs to the patient attending the intervention (transportation, childcare, missed wages) will be calculated against cost differences in outcomes.	Intake to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Overweight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 13-276