Black Women's Wellness Project

Not Applicable

Completed

• Conditions: Weight, Body; Knowledge, Attitudes, Practice
• Interventions: Behavioral: PRIDE counseling intervention

• Registration Number: NCT04063059
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2018-10-14
• Study Completion: 2018-11-15
• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 454

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	PRIDE counseling 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.

Primary Outcome Measures

Name	Time	Method
Weight (lb)	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.

Secondary Outcome Measures

Name	Time	Method
Height (inches)	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.
Waist Circumference (inches)	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.
Blood Pressure (mmHg)	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.
Total Cholesterol (mg/dL)	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.
High Density Lipoprotein Cholesterol (mg/dL)	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.
Low Density Lipoprotein Cholesterol (mg/dL)	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.
Triglycerides (mg/dL)	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.
Hemoglobin A1c	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.
Total Distance Walked (ft)	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.