Black Women's Wellness Project

NCT ID: NCT04063059

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2018-11-15

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.

Detailed Description

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Conditions

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Weight, Body Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

PRIDE counseling intervention

Intervention Type BEHAVIORAL

Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRIDE counseling intervention

Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Randall Brown

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BWWP

Identifier Type: -

Identifier Source: org_study_id

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