Women of Color and Family Obesity Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 454
- Primary Endpoint
- Weight (lb)
Study Overview
Brief Summary
The proposed randomized controlled trial will evaluate an educational self-management intervention in 450 African American women and weight management. It will be the first to use a culturally tailored in-person and telephone approach to address all aspects of wellness and social determinants for African American women to achieve optimal long term wellness for both self and family.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 20 Years to 59 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-identified African American woman, aged 20-59
- •BMI 27.5-57.4
- •Ability to walk unrestricted for > 3 min
- •Caretaker of a child -providing a meal at least 50% of days/week
- •Caretaker of at least one child aged 5 -12 years
- •Resides in Jackson, Saginaw, Ypsilanti, Lansing, Detroit (All cities in Michigan)
- •Speaks English fluently
Exclusion Criteria
- •<12 months postpartum
- •Active pregnancy
- •Prior or anticipated bariatric surgery
- •Non-ambulatory
- •History of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction)
- •Severe mental illness, neurologic disease and/or cognitive impairment
Arms & Interventions
Control
Usual care
Intervention
Subjects will be randomized to the program intervention which is a female-specific, culturally relevant, self-regulation based in-person group sessions and telephone counseling intervention designed for African American women who are overweight or obese.
Intervention: PRIDE counseling intervention (Behavioral)
Outcomes
Primary Outcomes
Weight (lb)
Time Frame: Closing Event (Month 12)
After 12 months all women will be invited to come to a clinical data collection event "Closing Event" where weight will be collected for all women on the same measurement scale. All measurements will be taken by project staff to ensure data validly.
Weight (lb)
Time Frame: Kick Off Event (Month 0)
All women will be invited to come to a clinical data collection event "Kick Off" where weight will be collected for all women on the same measurement scale. All measurements will be taken by project staff to ensure data validly.
Secondary Outcomes
- Height (inches)(Closing Event (Month 12))
- Waist Circumference (inches)(Closing Event (Month 12))
- Blood Pressure (mmHg)(Closing Event (Month 12))
- Total Cholesterol (mg/dL)(Closing Event (Month 12))
- High Density Lipoprotein Cholesterol (mg/dL)(Closing Event (Month 12))
- Low Density Lipoprotein Cholesterol (mg/dL)(Closing Event (Month 12))
- Triglycerides (mg/dL)(Closing Event (Month 12))
- Hemoglobin A1c(Closing Event (Month 12))
- Total Distance Walked (ft)(Closing Event (Month 12))
- Height (inches)(Kick Off Event (Month 0))
- Waist Circumference (inches)(Kick Off Event (Month 0))
- Blood Pressure (mmHg)(Kick Off Event (Month 0))
- Total Cholesterol (mg/dL)(Kick Off Event (Month 0))
- High Density Lipoprotein Cholesterol (mg/dL)(Kick Off Event (Month 0))
- Low Density Lipoprotein Cholesterol (mg/dL)(Kick Off Event (Month 0))
- Triglycerides (mg/dL)(Kick Off Event (Month 0))
- Hemoglobin A1c(Kick Off Event (Month 0))
- Total Distance Walked (ft)(Kick Off Event (Month 0))
Investigators
Randall Brown
PI
University of Michigan