- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441655
Families Implementing Good Health Traditions for Life (FIGHT for Life)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rakale C Quarells, PhD
- Phone Number: 404-752-1956
- Email: rquarells@msm.edu
Study Contact Backup
- Name: Asia K Rivers, MPH
- Phone Number: +1 (404) 752-1610
- Email: arivers@msm.edu
Study Locations
-
-
Georgia
-
Albany, Georgia, United States, 31705
- Recruiting
- Morehouse School of Medicine
-
Contact:
- Asia K Rivers, MPH
- Phone Number: 404-752-1610
- Email: arivers@msm.edu
-
Contact:
- Kenya Baker, MSPAS
- Phone Number: 3123 229-639-3103
- Email: kenya.baker@aaphc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old
- Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
- Parent/Guardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months
- Parent/child are ambulatory and able to participate in physical activity
Exclusion Criteria:
- Individuals with severe psychological disorders that may prevent/interfere with study participation
- Physical impairments that may prevent participation in moderate intensity physical activity;
- Previous diagnosis of diabetes
- History of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction or stroke;
- Person taking medications that may affect endpoint analyses
- Persons with co-morbid contraindications to physical activity or dietary changes.
- Currently pregnant or planning to become pregnant in the next year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Families Implementing Good Health Traditions for Life
Seven cohorts with a total of seventy families (10 families per cohort) will be enrolled in the study.
Families will meet for weekly for 16 weeks and be administered child and adult specific curriculums to encourage healthy lifestyle changes.
The adults will received the initial 16-week curriculum of the CDC's Diabetes Prevention Program, and the children will receive an aligned DPP-adapted curriculum.
|
The 16-session weekly curriculum will have five components: 1) strategies for monitoring food intake and reducing calories; 2) identifying and controlling both personal and social cues for unhealthy eating behaviors; 3) the role of stress in unhealthy eating and relapse prevention; 4) strategies for monitoring and improving physical activity and sedentary behaviors; and 5) strategies to improve family support and cohesion.
Parents and children will be divided into separate, 2-hour sessions most weeks.
The sessions will be co-facilitated by trained CHWs and research staff members.
As children of different ages will be participating, we will ensure enough staff are present to keep youth sessions well-coordinated in order to engage all ages.
All sessions will be held in community locations convenient to the families, such as YMCAs, faith-based institutions, federally qualified health centers, etc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Weight
Time Frame: 10 months
|
Parents enrolled in the family intervention will demonstrate a 4% reduction in weight at the end of the intervention.
|
10 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022805-14
- 2U54MD007602-36 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual Participant Data (IPD) collected during this study will not be shared with external researchers. The decision not to share IPD is based on considerations including participant confidentiality, informed consent limitations, and institutional data protection policies. All data will be reported in aggregate form in publications and presentations to ensure that no individual participant can be identified.
Qualified researchers may contact the study sponsor or principal investigator with specific inquiries; however, access to raw individual-level data will not be provided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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