Black Women's Wellness Project

August 19, 2019 updated by: Randall Brown, University of Michigan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
454

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Usual care
Active Comparator: Intervention
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
Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)
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.
Kick Off Event (Month 0)
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.
Closing Event (Month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BWWP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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