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Behavioral Intervention

Regulation of Cues for Childhood Obesity (FRESH-FR Trial)

N/A

Recruiting

Led By Kerri Boutelle, Ph.D.

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Child high on Food Responsiveness Scale (FR) with scores at 4 or higher

Child on stable medication regimen for 3+ months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline 3 months, 6 months, 12 months, and 18 months

Awards & highlights

FRESH-FR Trial Summary

This trial aims to compare different types of treatments for children who are overweight and highly responsive to food cues.

Who is the study for?

This trial is for children aged 7-12 with obesity who are very responsive to food. They must be in stable health, able to do physical activities, and not on any new medications for the past 3 months. A parent involved in meal prep must join too, speaking English at least at a 5th-grade level.Check my eligibility

What is being tested?

The study compares four approaches: Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education/energy intake reduction (ROC+), and Health Education (HE) to help kids with high food responsiveness manage their weight.See study design

What are the potential side effects?

Since this trial involves behavioral treatments and education rather than medication, there may not be direct side effects like those from drugs; however, changes in diet or activity could cause temporary discomfort or adjustment issues.

FRESH-FR Trial Eligibility Criteria

Inclusion Criteria

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

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My child often feels very hungry and wants to eat a lot.

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My child has been on the same medication for over 3 months.

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My child is between 7-12 years old and is overweight or obese.

FRESH-FR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline 3 months, 6 months, 12 months, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline 3 months, 6 months, 12 months, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline 3 months, 6 months, 12 months, 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

Change in Child Overeating episodes

Child age and sex adjusted body mass index z-score (BMIz)

Child percentage of the 95th percentile BMI (%BMIp95)

Secondary outcome measures

Child Energy Intake

Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire

Child Food Cue Responsiveness as measured during exposure to a preferred food

+13 more

FRESH-FR Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Regulation of Cues +Experimental Treatment1 Intervention

The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake

Group II: Regulation of CuesExperimental Treatment1 Intervention

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.

Group III: Family-Based TreatmentActive Control1 Intervention

The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.

Group IV: Health EducationActive Control1 Intervention

The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

2,359 Previous Clinical Trials

4,314,312 Total Patients Enrolled

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,588,495 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,764 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants still able to enroll in this ongoing trial?

"As per information on clinicaltrials.gov, this research is actively seeking volunteers. The trial was initially disclosed on March 1st, 2024 and last revised on February 26th, 2024."

Answered by AI

Do I meet the necessary requirements to participate in this clinical investigation?

"Participants aged between 7 and 12 years with a medical history of childhood obesity are eligible for enrollment in this trial, which has spots available for up to 280 individuals."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Yes, as per clinicaltrials.gov, this trial is actively enrolling participants. The trial was first listed on March 1st, 2024 and last revised on February 26th, 2024. It aims to recruit a total of 280 individuals across two designated locations."

Answered by AI

Are individuals 18 years of age and older eligible to participate in this study?

"Participants eligible for this research study must be between 7 and 12 years old. Among the ongoing clinical trials, there are a total of 151 studies focused on individuals under 18 years old and 27 aimed at those over 65."

Answered by AI

What is the primary objective of this medical study?

"The main objective of this research is to assess the percentage of child BMI relative to the 95th percentile (%BMIp95) over a span of 3, 6, 12, and 18 months. Secondary assessments will include parent inhibition as evaluated by the Stop Signal Task using food cues, child responsiveness to food stimuli through exposure to preferred foods involving sensory evaluation and craving ratings within a 5-minute session, and parent inhibition measured via the Go No Go (GNG) Task with food-related cues."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family, Responsibility, Education, Support, and Health for Food Responsiveness

Kerri Boutelle 2024. "Family, Responsibility, Education, Support, and Health for Food Responsiveness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06207110.

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