Community-based Obesity Treatment in African American Women After Childbirth

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.

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