Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
Primary Purpose
Overweight, Obesity, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial incentives
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Obesity, Pregnancy
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)
Sites / Locations
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral, incentives
Standard care
Arm Description
Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals
Participants receive standard obstetrical care from their provider
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cesarean delivery rate
Cesarean delivery rate (as a percent of total deliveries) will be assessed
Fetal macrosomia
Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.
Full Information
NCT ID
NCT02233673
First Posted
September 3, 2014
Last Updated
October 10, 2018
Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT02233673
Brief Title
Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
Official Title
Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Pregnancy
Keywords
Obesity, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral, incentives
Arm Type
Experimental
Arm Description
Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants receive standard obstetrical care from their provider
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Intervention Description
Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
Primary Outcome Measure Information:
Title
Gestational weight gain within the Institute of Medicine guidelines
Description
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 Outcome Measure Information:
Title
Cesarean delivery rate
Description
Cesarean delivery rate (as a percent of total deliveries) will be assessed
Time Frame
Time of delivery
Title
Fetal macrosomia
Description
Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.
Time Frame
At delivery
Other Pre-specified Outcome Measures:
Title
Cost of intervention
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33319756
Citation
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.
Results Reference
derived
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Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
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