- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829229
Community-based Obesity Treatment in African American Women After Childbirth
July 6, 2022 updated by: Temple University
Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Self-identification as African American
- Self-report pre-pregnancy BMI between 25-49.9 kg/m2
- Measured BMI at baseline between 25-49.9 kg/m2
- Philadelphia WIC participant
- Singleton birth
- Between 1 and 6 months postpartum
- Own a cell phone with an unlimited text messaging plan
- Able to participate in light physical activity (walking)
- Participants must be willing to comply with all study-related procedures
- Participants must be able to read and write fluently in English
Exclusion Criteria:
- BMI ≤ 24.9 or ≥ 50.0 kg/m2
- 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.
- Known atherosclerotic cardiovascular disease
- Known congestive heart failure
- Known diabetes mellitus (type 1 or type 2)
- Known thyroid disease
- Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
- History of testing HIV positive
- Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
- Current or recent history (past 6 months) of drug or alcohol abuse or dependence
- Participation in any weight control or investigational drug study within 6 weeks of screening
- Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
- 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
- Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
- Previous weight loss surgery
- History of bulimia or anorexia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care (UC)
Usual postpartum WIC care
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss (kilograms)
Time Frame: 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.
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At baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obesogenic dietary behaviors
Time Frame: 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.
|
At baseline and 12 months
|
Insulin Resistance
Time Frame: 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.
|
At baseline and 12 months
|
Health-related quality of life
Time Frame: 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.
|
At baseline and 12 months
|
Physical Activity
Time Frame: At baseline and 12 months
|
Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.
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At baseline and 12 months
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Physical Activity
Time Frame: 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.
|
At baseline and 12 months
|
Sleep
Time Frame: At baseline and 12 months
|
Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.
|
At baseline and 12 months
|
Sleep
Time Frame: At baseline and 12 months
|
Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Time Frame: 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.
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At baseline and 12 months
|
Hemoglobin A1c (HbA1c)
Time Frame: 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.
|
At baseline and 12 months
|
Lipids
Time Frame: 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.
|
At baseline and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
Time Frame: 12 months
|
The five steps are Reach the target population; Effectiveness; Adoption by target staff, settings or institutions; Implementation consistency, costs and adaptions made during delivery and Maintenance of intervention effects in individuals and settings over time.
Previously collected data such as target population characteristics; attrition and completion percentages; results related to primary, secondary and unintended outcomes; intervention fidelity; participant knowledge application and sustainability will be used within scope of 5 steps to determine dissemination potential.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharon J Herring, MD MPH, Temple University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 12, 2016
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23187
- R01HL130816 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Dr. Herring (PI) will ensure that all publications that result from data collected as part of this project will comply with the NIH public access policy.
Also, Dr. Herring agrees to develop a transportable de-identified database, codebook, and mechanism by which data can be shared with other investigators upon approval of the study's research team.
The Resource Sharing Plan will be reviewed and approved by Temple University's Institutional Review Board.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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