N/A
N=62
Reducing Obesity in Underserved Postpartum African American Women
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02448563 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) — 9; 12; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutrition and physical activity education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Medical Center
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff) |
9; 12; 11 | — |
| SECONDARY Change From Baseline Weight to 8 Weeks |
2.4; 2.2 | — |
| SECONDARY Participant Satisfaction as Measured by Questionnaire and Exit Interview |
100; 58; 60; 26; 73; 32 | — |
| SECONDARY Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire |
4.7; 4.2; 1.5; -1.2; -0.8; -2.8 | — |
| SECONDARY Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire |
0.1; 0.2; -0.02; -0.02; 0.1; 0.1 | — |
| SECONDARY Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale |
-0.1; 0.2; 0.4; 0.1; -0.6; -0.3 | — |
| SECONDARY Waist Circumference at 8 Weeks |
107.3; 108.1; 109.6; 109.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02448563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.