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OpenTrials
Completed

NCT Number: NCT04063059

Black Women's Wellness Project

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.

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Key information

Conditions

Weight, Body Behavior Body Weight Knowledge, Attitudes, Practice Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Weight (lb)

    Time frame: Kick Off Event (Month 0)

    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.

  2. Weight (lb)

    Time frame: Closing Event (Month 12)

    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 outcomes

  1. Height (inches)

    Time frame: Kick Off Event (Month 0)

    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.

  2. Height (inches)

    Time frame: Closing Event (Month 12)

    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.

  3. Waist Circumference (inches)

    Time frame: Kick Off Event (Month 0)

    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.

  4. Waist Circumference (inches)

    Time frame: Closing Event (Month 12)

    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.

  5. Blood Pressure (mmHg)

    Time frame: Kick Off Event (Month 0)

    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.

  6. Blood Pressure (mmHg)

    Time frame: Closing Event (Month 12)

    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.

  7. Total Cholesterol (mg/dL)

    Time frame: Kick Off Event (Month 0)

    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.

  8. Total Cholesterol (mg/dL)

    Time frame: Closing Event (Month 12)

    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.

  9. High Density Lipoprotein Cholesterol (mg/dL)

    Time frame: Kick Off Event (Month 0)

    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.

  10. High Density Lipoprotein Cholesterol (mg/dL)

    Time frame: Closing Event (Month 12)

    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.

  11. Low Density Lipoprotein Cholesterol (mg/dL)

    Time frame: Kick Off Event (Month 0)

    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.

  12. Low Density Lipoprotein Cholesterol (mg/dL)

    Time frame: Closing Event (Month 12)

    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.

  13. Triglycerides (mg/dL)

    Time frame: Kick Off Event (Month 0)

    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.

  14. Triglycerides (mg/dL)

    Time frame: Closing Event (Month 12)

    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.

  15. Hemoglobin A1c

    Time frame: Kick Off Event (Month 0)

    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.

  16. Hemoglobin A1c

    Time frame: Closing Event (Month 12)

    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.

  17. Total Distance Walked (ft)

    Time frame: Kick Off Event (Month 0)

    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.

  18. Total Distance Walked (ft)

    Time frame: Closing Event (Month 12)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Women of Color and Family Obesity Management

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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