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Community-based Obesity Treatment in African American Women After Childbirth

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Temple University

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Community-based obesity treatment (PP)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02829229
R01HL130816 (U.S. NIH Grant/Contract)
23187

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Self-identification as African American
  2. Self-report pre-pregnancy BMI between 25-49.9 kg/m2
  3. Measured BMI at baseline between 25-49.9 kg/m2
  4. Philadelphia WIC participant
  5. Singleton birth
  6. Between 1 and 6 months postpartum
  7. Own a cell phone with an unlimited text messaging plan
  8. Able to participate in light physical activity (walking)
  9. Participants must be willing to comply with all study-related procedures
  10. Participants must be able to read and write fluently in English

Exclusion criteria

  1. BMI ≤ 24.9 or ≥ 50.0 kg/m2
  2. Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure > 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
  3. Known atherosclerotic cardiovascular disease
  4. Known congestive heart failure
  5. Known diabetes mellitus (type 1 or type 2)
  6. Known thyroid disease
  7. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
  8. History of testing HIV positive
  9. Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
  10. Current or recent history (past 6 months) of drug or alcohol abuse or dependence
  11. Participation in any weight control or investigational drug study within 6 weeks of screening
  12. Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
  13. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
  14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
  15. Previous weight loss surgery
  16. History of bulimia or anorexia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Usual care (UC)
No Intervention group
Description:
Usual postpartum WIC care
Community-based obesity treatment (PP)
Experimental group
Description:
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.
Treatment:
Behavioral: Community-based obesity treatment (PP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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