Black Women's Wellness Project

University of Michigan

Status: Completed

Conditions: Weight, Body; Knowledge, Attitudes, Practice

Treatments: Behavioral: PRIDE counseling intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04063059

BWWP

Details and patient eligibility

About

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.

Enrollment: 454 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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454 participants in 2 patient groups

Intervention

Active Comparator group

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.

Treatment:

Behavioral: PRIDE counseling intervention

Control

No Intervention group

Description:

Usual care