NCT02829229

Community-based Obesity Treatment in African American Women After Childbirth

Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effect of the community-based obesity treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.

Detailed description

The investigators propose to randomize overweight or obese, African American postpartum WIC participants (n=300) to either usual care (UC) or a community-based obesity treatment (PP) arm. Recruitment will occur in 6 of Philadelphia Women Infants Children's (WIC) clinic sites in the early postpartum period (≤ 6 months after birth). Once enrolled, participants will complete surveys and baseline assessments of their weight, waist circumference, blood pressure, and height at The Center for Obesity Research and Education (CORE). Participants will also have a fasting blood sample taken. Study staff will administer a number of questionnaires assessing demographics, psychosocial factors, contextual factors, and behavioral targets via questionnaires prior to randomization. Participants will then be randomized to the 12-month postpartum weight loss intervention (PP) or usual care (UC). Additional assessments will be conducted at 6 and 12 months post baseline. The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook. Data will be analyzed using an intent-to-treat (ITT) approach where subjects are analyzed according to their treatment assignment at randomization, regardless of level of engagement. The primary outcome is weight loss at 12 months. If successful, the expected results could provide a sustainable, low-cost, postpartum weight loss intervention model for widespread dissemination to reduce disparities in obesity and cardiometabolic comorbidities.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Community-based obesity treatment (PP)	Participants in the treatment (PP) arm will receive a 5-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; 4)Video testimonials \& 5)Interpersonal counseling. Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-01-01
• Completion: 2021-06-01
• First posted: 2016-07-12
• Last updated: 2022-07-07

Locations

1 site across 1 country: United States