Knowledge, Attitudes, Practice, Weight, Body
Conditions
Keywords
Weight Management, Obesity, African American, Women
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.
Interventions
BEHAVIORALPRIDE 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight (lb) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference (inches) | 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. |
| Blood Pressure (mmHg) | 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. |
| Total Cholesterol (mg/dL) | 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. |
| High Density Lipoprotein Cholesterol (mg/dL) | 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. |
| Height (inches) | 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. |
| Triglycerides (mg/dL) | 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. |
| Hemoglobin A1c | 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. |
| Total Distance Walked (ft) | 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. |
| Low Density Lipoprotein Cholesterol (mg/dL) | 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. |
Outcome results
None listed