- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063059
Black Women's Wellness Project
August 19, 2019 updated by: Randall Brown, University of Michigan
Women of Color and Family Obesity Management
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
454
Phase
- Not Applicable
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
20 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual care
|
|
Active Comparator: 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.
|
Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Kick Off Event (Month 0)
|
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.
|
Closing Event (Month 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height (inches)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where height will be collected for all women on the same stadiometer.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Height (inches)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where height will be collected for all women on the same stadiometer.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Waist Circumference (inches)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where waist circumference will be collected for all women using the same measuring tape.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Waist Circumference (inches)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where waist circumference will be collected for all women using the same measuring tape.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Blood Pressure (mmHg)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where blood pressure will be collected for all women using the same electronic blood pressure machine on their non-dominant arm.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Blood Pressure (mmHg)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where blood pressure will be collected for all women using the same electronic blood pressure machine on their non-dominant arm.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Total Cholesterol (mg/dL)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where total cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Total Cholesterol (mg/dL)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where total cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
High Density Lipoprotein Cholesterol (mg/dL)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where High Density Lipoprotein Cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
High Density Lipoprotein Cholesterol (mg/dL)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where High Density Lipoprotein Cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Low Density Lipoprotein Cholesterol (mg/dL)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where Low Density Lipoprotein Cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Low Density Lipoprotein Cholesterol (mg/dL)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where Low Density Lipoprotein Cholesterol will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Triglycerides (mg/dL)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where triglycerides will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Triglycerides (mg/dL)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where triglycerides will be collected for all women using the same CardioCheck PA Analyzer machine.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Hemoglobin A1c
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where Hemoglobin A1c will be collected for all women using the same A1C Now+ machine.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Hemoglobin A1c
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where Hemoglobin A1c will be collected for all women using the same A1C Now+ machine.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Total Distance Walked (ft)
Time Frame: Kick Off Event (Month 0)
|
All women will be invited to come to a clinical data collection event "Kick Off" where women will walk for 6 minutes and total distance will be measured by the same measuring tape.
All measurements will be taken by project staff to ensure data validly.
|
Kick Off Event (Month 0)
|
Total Distance Walked (ft)
Time Frame: Closing Event (Month 12)
|
All women will be invited to come to a clinical data collection event "Closing Event" where women will walk for 6 minutes and total distance will be measured by the same measuring tape.
All measurements will be taken by project staff to ensure data validly.
|
Closing Event (Month 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2016
Primary Completion (Actual)
October 14, 2018
Study Completion (Actual)
November 15, 2018
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 21, 2019
Study Record Updates
Last Update Posted (Actual)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BWWP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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