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Black Women's Wellness Project

Primary Purpose

Weight, Body, Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRIDE counseling intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight, Body focused on measuring Weight Management, Obesity, African American, Women

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    Usual care

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    August 19, 2019
    Last Updated
    August 19, 2019
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04063059
    Brief Title
    Black Women's Wellness Project
    Official Title
    Women of Color and Family Obesity Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    October 14, 2018 (Actual)
    Study Completion Date
    November 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight, Body, Knowledge, Attitudes, Practice
    Keywords
    Weight Management, Obesity, African American, Women

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    454 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    PRIDE counseling intervention
    Intervention Description
    Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.
    Primary Outcome Measure Information:
    Title
    Weight (lb)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Weight (lb)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Secondary Outcome Measure Information:
    Title
    Height (inches)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Height (inches)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Waist Circumference (inches)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Waist Circumference (inches)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Blood Pressure (mmHg)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Blood Pressure (mmHg)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Total Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Total Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    High Density Lipoprotein Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    High Density Lipoprotein Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Low Density Lipoprotein Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Low Density Lipoprotein Cholesterol (mg/dL)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Triglycerides (mg/dL)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Triglycerides (mg/dL)
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Hemoglobin A1c
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Hemoglobin A1c
    Description
    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.
    Time Frame
    Closing Event (Month 12)
    Title
    Total Distance Walked (ft)
    Description
    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.
    Time Frame
    Kick Off Event (Month 0)
    Title
    Total Distance Walked (ft)
    Description
    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.
    Time Frame
    Closing Event (Month 12)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Identify as being female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Black Women's Wellness Project

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