Black Women's Wellness Project

NCT04063059 | Completed DMC

• 1 other identifier: BWWP
• Study Type: interventional
• Target: 454
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight, Body; Knowledge, Attitudes, Practice

Keywords

Weight Management; Obesity; African American; Women

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Height (inches)

  Kick Off Event (Month 0)

• Height (inches)

  Closing Event (Month 12)

• Waist Circumference (inches)

  Kick Off Event (Month 0)

• Waist Circumference (inches)

  Closing Event (Month 12)

• Blood Pressure (mmHg)

  Kick Off Event (Month 0)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Usual care

Interventions

PRIDE counseling intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 20 Years - 59 Years
• Gender Eligibility Details: Identify as being female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Body Weight; Behavior; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: May 1, 2016
• Primary Completion: October 14, 2018
• Study Completion: November 15, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08