Clinical trial NCT02233673: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Pregnancy
Keywords: Obesity
Pregnancy
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-09-08
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Gestational weight gain within the Institute of Medicine guidelines
timeFrame: At time of delivery
Secondary outcomes:
measure: Cesarean delivery rate
timeFrame: Time of delivery
measure: Fetal macrosomia
timeFrame: At delivery
Other outcomes:
measure: Cost of intervention
timeFrame: Intake to 6 weeks postpartum
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
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.