Black Women's Wellness Project

Study Overview
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Brief Summary
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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.

Official Title
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Women of Color and Family Obesity Management

Conditions
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Weight, Body, Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: PRIDE counseling intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>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. | Behavioral: PRIDE counseling intervention<br>* Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (lb) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Management, Obesity, African American, Women