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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

BMI≥95th percentile for age and gender

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

Select...

My BMI is in the top 5% for my age and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month follow-up 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 of body fat

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Florida State UniversityOTHER

202 Previous Clinical Trials

31,427 Total Patients Enrolled

3 Trials studying Metabolic Syndrome

103 Patients Enrolled for Metabolic Syndrome

Medical University of South CarolinaLead Sponsor

936 Previous Clinical Trials

7,396,480 Total Patients Enrolled

1 Trials studying Metabolic Syndrome

477 Patients Enrolled for Metabolic Syndrome

Wayne State UniversityOTHER

309 Previous Clinical Trials

108,700 Total Patients Enrolled

1 Trials studying Metabolic Syndrome

40 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

Recent research and studies

clinicaltrials.govStudy

FIT Families Multicomponent Obesity Intervention for African American Adolescents

Phillipe Cunningham 2021. "FIT Families Multicomponent Obesity Intervention for African American Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04974554.

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