Community-based Obesity Treatment in African American Women After Childbirth

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Community-based obesity treatment (PP)

• Registration Number: NCT02829229
• Lead Sponsor: Temple University

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.

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Study Start: 2016-09
• Primary Completion: 2021-01
• Study Completion: 2021-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community-based obesity treatment (PP)	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.

Primary Outcome Measures

Name	Time	Method
Weight loss (kilograms)	At baseline and 12 months	Weight will be measured using a calibrated scale at baseline and 12-month follow-up. Weight loss will be calculated as the difference between mean 12-month and baseline weight in kilograms.

Secondary Outcome Measures

Name	Time	Method
Physical Activity	At baseline and 12 months	Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.
Sleep	At baseline and 12 months	Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.
Obesogenic dietary behaviors	At baseline and 12 months	Using National Cancer Institute's Diet History Questionnaire, the investigators will assess categories of sugary drink intake, fast/fried food intake, and snacking at baseline and 12-month follow-up.
Insulin Resistance	At baseline and 12 months	Blood will be drawn to assess insulin resistance (insulin and glucose). The Homeostatic model assessment for Insulin Resistance (HOMA-IR) calculation will be used to quantify participant mean insulin resistance at baseline and 12-month follow-up.
Health-related quality of life	At baseline and 12 months	Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.
Hemoglobin A1c (HbA1c)	At baseline and 12 months	Hemoglobin A1c test will be performed by a lab to identify the 3-month average plasma glucose concentration at baseline and 12-month follow-up. The investigators will categorize participants as no diabetes (HbA1c \<5.7), prediabetes (HBA1c 5.7-6.4), and diabetes (HBA1c \>6.4) at both timepoints.
Lipids	At baseline and 12 months	Total cholesterol test will be performed by a lab to identify mean total blood cholesterol level, low density lipoprotein and high density lipoprotein levels at baseline and 12-month follow-up.

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States