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

NCT02233673 | Completed

• 1 other identifier: 13-276
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Pregnancy

Outcome Measures

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.

  At time of delivery

Secondary Outcomes (2)

• Cesarean delivery rate

  Time of delivery

• Fetal macrosomia

  At delivery

Other Outcomes (1)

• Cost of intervention

  Intake to 6 weeks postpartum

Study Arms (2)

Behavioral, incentives

EXPERIMENTAL

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

Behavioral: Financial incentives

Standard care

NO INTERVENTION

Participants receive standard obstetrical care from their provider

Interventions

Financial incentives BEHAVIORAL

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

Behavioral, incentives

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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

You may not qualify if:

• Major fetal congenital or chromosomal anomaly
• Women with a restricted diet (i.e., celiac disease, prior bariatric surgery, Phenylketonuria, or other metabolic disorder)

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 33319756 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 8, 2014
• Study Start: March 1, 2014
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

US (1)