Clinical trial NCT02829229: Community-based Obesity Treatment in African American Women After Childbirth
Official title: Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-07-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight loss (kilograms)
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Obesogenic dietary behaviors
timeFrame: At baseline and 12 months
measure: Insulin Resistance
timeFrame: At baseline and 12 months
measure: Health-related quality of life
timeFrame: At baseline and 12 months
measure: Physical Activity
timeFrame: At baseline and 12 months
measure: Physical Activity
timeFrame: At baseline and 12 months
measure: Sleep
timeFrame: At baseline and 12 months
measure: Sleep
timeFrame: At baseline and 12 months
measure: Sleep
timeFrame: At baseline and 12 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: At baseline and 12 months
measure: Lipids
timeFrame: At baseline and 12 months
Other outcomes:
measure: Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
timeFrame: 12 months
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Sharon J Herring, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: