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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
Must not have
Serious cognitive impairment (e.g., inability to complete questionnaires)
Thought disorder (e.g., schizophrenia or other psychosis), suicidal, or homicidal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the FIT Families program, which helps African American teens and their families adopt healthier habits through regular visits, motivational talks, and practical skills training. It targets obese African American adolescents aged 12-17 because they have high rates of obesity and related health issues. The program aims to reduce obesity by encouraging healthy behaviors and providing support at home. The FIT Families program integrates cultural tailoring, positive parenting, and motivational strategies to help African American adolescents reduce obesity.
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.
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.
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 belowSelect...
My BMI is in the top 5% for my age and gender.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have difficulty understanding or completing questionnaires due to cognitive issues.
Select...
I do not have schizophrenia, other psychosis, and am not suicidal or homicidal.
Select...
My obesity is due to medication I take for another health issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Height
Percent of body fat
Weight
Secondary study objectives
Brief Symptom Inventory
Delayed Reward Discounting Task
Flanker task
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Metabolic Syndrome, particularly those similar to the FIT Families trial, involve multicomponent lifestyle interventions that include dietary changes, increased physical activity, and behavioral modifications. These treatments work by improving insulin sensitivity, reducing body weight, and lowering blood pressure and lipid levels.
Dietary changes focus on reducing caloric intake and choosing healthier foods, aiding in weight loss and metabolic improvements. Physical activity enhances glucose uptake by muscles and boosts cardiovascular health.
Behavioral modifications help patients adhere to these lifestyle changes by addressing psychological and social factors. These mechanisms are vital for Metabolic Syndrome patients as they address the underlying causes, such as obesity and insulin resistance, thereby reducing the risk of type 2 diabetes and cardiovascular diseases.
Find a Location
Who is running the clinical trial?
Florida State UniversityOTHER
219 Previous Clinical Trials
35,994 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
103 Patients Enrolled for Metabolic Syndrome
Medical University of South CarolinaLead Sponsor
966 Previous Clinical Trials
7,399,260 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
477 Patients Enrolled for Metabolic Syndrome
Wayne State UniversityOTHER
314 Previous Clinical Trials
109,728 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
40 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My obesity is due to a chronic condition like Down syndrome.I have difficulty understanding or completing questionnaires due to cognitive issues.I do not have schizophrenia, other psychosis, and am not suicidal or homicidal.I am between 12 and 17 years old and identify as African American.My obesity is due to medication I take for another health issue.I am a teenager living mostly with my main caregiver within 30 miles of MUSC.My primary caregiver is overweight or obese and willing to join the treatment.My BMI is in the top 5% for my age and gender.
Research Study Groups:
This trial has the following groups:- Group 1: Home-Based Family Support
- Group 2: FIT Families
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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