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Family-Based Treatment for Childhood Obesity

N/A

Recruiting

Led By Hollie Raynor, PhD RD LDN

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

one adult caregiver (> 18 years) living in the household with a BMI > 25 kg/m2 willing to attend treatment meetings

age between 8 and 12 years

Must not have

Child or adult caregiver report major psychiatric diseases or organic brain syndromes

Child report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 18 months, adult caregiver having bariatric surgery in the previous two years or planning to have bariatric surgery in the next 18 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, and 18 months

Awards & highlights

Summary

This trial will test if a limited variety of high-energy-dense foods can help reduce body mass index over time, and if baseline habituation rate is a predictor of success.

Who is the study for?

This trial is for children aged 8-12 with a BMI over the 85th percentile and an adult caregiver in the household with a BMI over 25 kg/m2. Both must live together full-time, be able to walk two blocks without stopping, not have had or plan bariatric surgery within certain time frames, and not be pregnant or planning pregnancy.

What is being tested?

The study tests if limiting high-energy-dense food variety affects body mass index (BMI) in kids during an 18-month family-based treatment (FBT). It compares standard FBT against FBT plus varied diet interventions, measuring changes in weight, eating habits, and physical activity.

What are the potential side effects?

Since this trial involves dietary intervention rather than medication, typical drug side effects are not expected. However, participants may experience changes in appetite or food preferences due to alterations in their usual diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an adult caregiver with a BMI over 25 willing to attend treatment meetings.

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I am between 8 and 12 years old.

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I have an adult caregiver with a BMI over 25 willing to attend treatment meetings.

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I am between 8 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or my caregiver report having a major psychiatric disease or brain condition.

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I am a child planning or having had weight loss surgery, or my caregiver is planning or has had it.

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I am currently trying to lose weight or have lost more than 5% of my body weight in the last 6 months.

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I cannot walk 2 blocks without stopping.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child and adult body mass index

Child and adult salivary habituation

Secondary study objectives

Child Routines

Child and Adult Sleep Habits

Child and adult dietary Intake

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FBT+VarietyExperimental Treatment1 Intervention

The FBT+Variety condition will receive FBT along with a limited variety prescription. In this prescription families will identify two RED foods, a dinner entree and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED entrees and snack foods.

Group II: FBT (family-based behavioral treatment)Active Control1 Intervention

This condition will be prescribed the Traffic Light Diet (1000-1500 kcal/day, < 2 servings/day of RED [non-nutrient-dense, energy-dense] foods) and a > 60 min/day of MVPA prescription for children and > 30 min/day of MVPA for adults at least 5 days/week. FBT will receive a family-based, behavioral intervention to assist the targeted child and a participating adult caregiver with making changes in energy balance behaviors.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Miriam HospitalOTHER

241 Previous Clinical Trials

37,432 Total Patients Enrolled

75 Trials studying Obesity

14,983 Patients Enrolled for Obesity

University at BuffaloOTHER

132 Previous Clinical Trials

98,823 Total Patients Enrolled

6 Trials studying Obesity

353 Patients Enrolled for Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,381 Previous Clinical Trials

4,314,946 Total Patients Enrolled

453 Trials studying Obesity

588,809 Patients Enrolled for Obesity

Media Library

FBT Clinical Trial Eligibility Overview. Trial Name: NCT04027426 — N/A

Obesity Research Study Groups: FBT (family-based behavioral treatment), FBT+Variety

Obesity Clinical Trial 2023: FBT Highlights & Side Effects. Trial Name: NCT04027426 — N/A

FBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04027426 — N/A

~10 spots leftby Jan 2025

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