Reducing Obesity in Underserved Postpartum African American Women
RENEW
3 other identifiers
interventional
128
0 countries
N/A
Brief Summary
In this proposal, the investigators will develop a culturally-tailored, 8-week clinic-based weight loss program to reduce obesity among postpartum African American (AA) adult women that can be integrated into a postpartum care model within a clinical setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedResults Posted
Study results publicly available
August 9, 2017
CompletedAugust 9, 2017
June 1, 2017
2.1 years
May 12, 2015
July 25, 2016
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Weekly up to 8 weeks
Secondary Outcomes (6)
Change From Baseline Weight to 8 Weeks
Baseline and 8 weeks
Participant Satisfaction as Measured by Questionnaire and Exit Interview
8 weeks
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Baseline and 8 weeks
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Baseline and 8 weeks
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Baseline and 8 weeks
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALWeekly, in-person, support groups providing nutrition and physical activity education
Control
NO INTERVENTIONStandard of care - one counseling visit with a study dietitian
Interventions
Eligibility Criteria
You may qualify if:
- Pre-Natal:
- BMI greater than or equal to 25
- Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
- English-speaking
- Post-partum:
- Live birth (based on medical record review)
You may not qualify if:
- Pre-Natal:
- Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
- Previous enrollment in the Birth Sister's program prior to the study
- Post-partum:
- Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ashley McCarthy, Clinical Research Manager
- Organization
- Boston Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline M. Apovian, MD
Professor of Medicine and Pediatrics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Pediatrics
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 19, 2015
Study Start
August 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 9, 2017
Results First Posted
August 9, 2017
Record last verified: 2017-06