Black Women's Wellness Project

Knowledge, Attitudes, Practice Clinical Trial

Official title:

Women of Color and Family Obesity Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063059
• Other study ID #: BWWP
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: November 15, 2018

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: November 15, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Knowledge, Attitudes, Practice
• Weight, Body

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)