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Family-Based Obesity Intervention for Childhood Obesity

N/A
Recruiting
Led By Phillippe B Cunningham, Ph.D.
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents (ages 12-17) self-identifying as AA
Adolescent residing primarily with the primary caregiver within 30 miles of the MUSC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month follow-up
Awards & highlights

Study Summary

This trial will test how well a family-based behavioral intervention works to reduce obesity in African American adolescents.

Who is the study for?
This trial is for African American adolescents aged 12-17 with obesity, living within 30 miles of the MUSC. They must have a BMI in the 95th percentile or higher and a primary caregiver who is overweight or obese willing to participate. Both must get physical activity clearance from a healthcare provider. Those with obesity due to chronic conditions, serious cognitive impairments, thought disorders, or medication-induced obesity cannot join.Check my eligibility
What is being tested?
The study tests 'FIT Families', a culturally tailored behavioral intervention aimed at reducing obesity in African American teens and their caregivers against an attention control condition. It's delivered by Community Health Workers which could make it sustainable if effective.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on lifestyle changes rather than medication, typical medical side effects are not expected. However, participants may experience fatigue or stress related to new exercise routines and dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 17 years old and identify as African American.
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I am a teenager living mostly with my main caregiver within 30 miles of MUSC.
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My primary caregiver is overweight or obese and willing to join the treatment.
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My BMI is in the top 5% for my age and gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for six months during treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily for six months during treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height
Percent overweight
Weight
Secondary outcome measures
Brief Symptom Inventory
Delayed Reward Discounting Task
Flanker task
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FIT FamiliesExperimental Treatment1 Intervention
1. FIT Families is a 6 month comprehensive multicomponent family-based behavioral intervention delivered by Community Health Workers (CHWs). FIT Families integrates home-based service delivery, Motivational Interviewing (MI; intrinsic motivation), Cognitive Behavior Skills Treatment (CBST; skills acquisition), supervised physical activity (PA), and Contingency Management (CM; extrinsic motivation). Sessions occur twice weekly for the first three months, and weekly for the second three months.
Group II: Home-Based Family SupportActive Control1 Intervention
2. Home-based Family Support (HBFS). Adolescents and their primary caregiver randomly assigned to HBFS will receive 6 months of weekly, home-based, client-centered, non-directive supportive family counseling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIT
2022
Completed Phase 2
~13520

Find a Location

Who is running the clinical trial?

Florida State UniversityOTHER
197 Previous Clinical Trials
30,288 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
103 Patients Enrolled for Metabolic Syndrome
Medical University of South CarolinaLead Sponsor
931 Previous Clinical Trials
7,393,651 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
477 Patients Enrolled for Metabolic Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,077 Total Patients Enrolled
34 Trials studying Metabolic Syndrome
19,190 Patients Enrolled for Metabolic Syndrome

Media Library

FIT Families Multicomponent Obesity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04974554 — N/A
Metabolic Syndrome Research Study Groups: Home-Based Family Support, FIT Families
Metabolic Syndrome Clinical Trial 2023: FIT Families Multicomponent Obesity Intervention Highlights & Side Effects. Trial Name: NCT04974554 — N/A
FIT Families Multicomponent Obesity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04974554 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for potential participants in this medical trial?

"This research trial is actively seeking volunteers, having been initially posted on May 1st 2021 and last updated on May 3rd 2022."

Answered by AI

What primary outcomes is this research attempting to demonstrate?

"This clinical trial aims to measure Height over a 12-month follow up period. Additional objectives include assessing the preference for immediate rewards versus delayed ones via Delayed Reward Discounting Task, gauging Quality of Life through Neuro-QOL T scores, and measuring Symptoms of Metabolic Syndrome with sphygmomanometer readings."

Answered by AI

How many participants are being surveyed in this clinical investigation?

"Affirmative. On clinicaltrials.gov, it is stated that this study has opened its recruitment process on May 1st 2021 and the last update was made in early May 2022. The research requires 360 people to take part at one location."

Answered by AI
~153 spots leftby Apr 2026