Weight, BodyNCT04063059
Black Women's Wellness Project
A study testing PRIDE counseling intervention in people with Weight, Body and Knowledge, Attitudes, Practice, run by University of Michigan.
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… Read more about this study
- Who is it for?
- Ages 20 to 59 years, women only
- Conditions the study is for
- Weight, Body, Knowledge, Attitudes, Practice
- What is being tested?
- PRIDE counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- <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
About this study
Official title: Women of Color and Family Obesity Management
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
- Being tested
- PRIDE counseling intervention
- Keywords
- Weight Management, Obesity, African American, Women
- Medical subject headings
- Body Weight, Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIDE counseling interventionBehavioural
Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PRIDE counseling intervention |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Closing Event (Month 12)
Secondary outcomes (18)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
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.
Measured: Kick Off Event (Month 0)
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.
Measured: Closing Event (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 May 2016
- Primary completion14 Oct 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight, BodyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Brown, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063059
- Sponsor's protocol ID
- BWWP
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women of Color and Family Obesity Management
- ClinicalTrials.gov ID
- NCT04063059
- Acronym / sponsor ID
- BWWP
- Conditions
- Weight, Body, Knowledge, Attitudes, Practice
- Keywords
- Weight Management, Obesity, African American, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: PRIDE counseling interventionSubjects 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. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- <12 months postpartum
- Active pregnancy
- Prior or anticipated bariatric surgery
- Non-ambulatory
- History of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIDE counseling interventionStep-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling. | Behavioural | Intervention |
Primary outcome
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.
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.
18 secondary outcomes
Height (inches)
Time frame: Kick Off Event (Month 0)
Height (inches)
Time frame: Closing Event (Month 12)
Waist Circumference (inches)
Time frame: Kick Off Event (Month 0)
Waist Circumference (inches)
Time frame: Closing Event (Month 12)
Blood Pressure (mmHg)
Time frame: Kick Off Event (Month 0)
Blood Pressure (mmHg)
Time frame: Closing Event (Month 12)
Total Cholesterol (mg/dL)
Time frame: Kick Off Event (Month 0)
Total Cholesterol (mg/dL)
Time frame: Closing Event (Month 12)
High Density Lipoprotein Cholesterol (mg/dL)
Time frame: Kick Off Event (Month 0)
High Density Lipoprotein Cholesterol (mg/dL)
Time frame: Closing Event (Month 12)
Low Density Lipoprotein Cholesterol (mg/dL)
Time frame: Kick Off Event (Month 0)
Low Density Lipoprotein Cholesterol (mg/dL)
Time frame: Closing Event (Month 12)
Triglycerides (mg/dL)
Time frame: Kick Off Event (Month 0)
Triglycerides (mg/dL)
Time frame: Closing Event (Month 12)
Hemoglobin A1c
Time frame: Kick Off Event (Month 0)
Hemoglobin A1c
Time frame: Closing Event (Month 12)
Total Distance Walked (ft)
Time frame: Kick Off Event (Month 0)
Total Distance Walked (ft)
Time frame: Closing Event (Month 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PRIDE counseling intervention in people with Weight, Body and Knowledge, Attitudes, Practice, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (lb) (time frame: Kick Off Event (Month 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.