Community-based Obesity Treatment in African American Women After Childbirth

NCT ID: NCT02829229

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care (UC)

Usual postpartum WIC care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Community-based obesity treatment (PP)

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.

Group Type: EXPERIMENTAL

Community-based obesity treatment (PP)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon J Herring, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01HL130816

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23187

Identifier Type: -

Identifier Source: org_study_id