What side effects are associated with this type of intervention?

Common treatments for Metabolic Syndrome, particularly those involving lifestyle modifications like diet and exercise, generally have minimal side effects. However, some individuals may experience temporary discomfort such as muscle soreness, fatigue, or gastrointestinal issues when starting a new exercise or dietary regimen. Pharmacotherapy, if used, can have more specific side effects depending on the medication. For example, medications for managing blood pressure, cholesterol, or blood sugar levels can cause dizziness, gastrointestinal disturbances, or changes in blood glucose levels. It is important to discuss potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for components of Metabolic Syndrome, focusing on both pharmacological and lifestyle interventions. Pharmacological treatments include drugs like metformin for insulin resistance, statins for dyslipidemia, and antihypertensives for high blood pressure. For obesity, the FDA has approved medications such as orlistat, phentermine-topiramate, and naltrexone-bupropion. However, similar to the FIT Families trial, which emphasizes a multicomponent family-based behavioral intervention, the FDA also supports lifestyle interventions that include dietary changes, increased physical activity, and behavioral therapy as foundational treatments for Metabolic Syndrome.

What other types of research exist?

Promising alternatives to FIT Families for Metabolic Syndrome patients include: 1) The B.E. S.T.R.O.N.G. program, which is a comprehensive family-based multidisciplinary child obesity treatment program using an Internet-based health tracker. 2) Pharmacological treatments such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide) and SGLT2 inhibitors, which have shown efficacy in managing obesity and metabolic syndrome. 3) Intensive lifestyle interventions like those used in the Look AHEAD trial, focusing on diet, exercise, and behavioral therapy. 4) Surgical options such as laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which have been effective in severe obesity cases.

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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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month follow-up for reporting.

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 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 / 4Eligibility criteria met

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.