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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, and 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child and adult body mass index

Child and adult salivary habituation

Secondary outcome measures

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Miriam HospitalOTHER

238 Previous Clinical Trials

37,319 Total Patients Enrolled

75 Trials studying Obesity

14,984 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

2,359 Previous Clinical Trials

4,314,435 Total Patients Enrolled

446 Trials studying Obesity

588,782 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

Frequently Asked Questions

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

Is the age requirement for this research project confined to individuals under 40?

"In order to be admissible for this trial, the age of potential participants must range between 8 and 12 years old."

Answered by AI

Who is eligible to take part in this trial?

"Participants aged 8-12 and meeting the criteria of a BMI > 85th percentile alongside an adult caretaker with a baseline BMI > 25 kg/m2 are being admitted for this trial focused on obesity. In addition, it's imperative that the accompanying guardian is willing to attend all scheduled meetings."

Answered by AI

Are volunteers currently being accepted for participation in this investigation?

"Affirmative. According to clinicaltrials.gov, the protocol for this medical experiment is currently recruiting participants who will be monitored at 1 site. The trial was launched on October 29th 2019 and its most recent update was made on October 30th 2022; it seeks 156 volunteers in total."

Answered by AI

What effects does this trial hope to produce?

"The primary endpoint of this trial will measure the Child and Adult Body Mass Index over a period spanning from 0 to 6 months, and then again at 6 to 18 months. Secondary endpoints include evaluations for Child Routines, Home Food Inventory, and Compliance/Process Data such as weekly self-monitoring records completed or number of treatment sessions attended."

Answered by AI

How many test subjects have enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this medical experiment is actively recruiting participants, beginning October 29th 2019 and most recently updated on October 30th 2022. The research team seeks 156 volunteers from a single institution."

Answered by AI