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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233673
• Other study ID #: 13-276
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 28, 2017

Study information

• Verified date: October 2018
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• Financial incentives
Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Cesarean delivery rate	Cesarean delivery rate (as a percent of total deliveries) will be assessed	Time of delivery
Secondary	Fetal macrosomia	Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight >4000g) will be assessed.	At delivery