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

Obesity, Childhood Clinical Trial

— FRESH-FR  

Official title:

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207110
• Other study ID #: 806055
• Secondary ID: 1R01DK135599
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Est. completion date: January 1, 2029

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Kaylen Moline, MPH
• Phone: 1-855-827-3498
• Email: chear[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).

Description:

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that FBT has merit for some children, but not all, this study will compare ROC to FBT, ROC with nutrition education and reducing energy intake (ROC+), and Health Education (HE). Treatment will consist of weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months for a total of 20 sessions. The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness (FR) and their parent and will conduct assessments at baseline, post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Informed assent and parental consent

2. A child with overweight or obesity (= 85th BMI%) aged 7-12 years of age

3. Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 4 or higher constituting a child with high FR.

4. A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level

5. Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments

6. Child and parent is on stable medication regimen for medications that can impact weight (3+ months)

7. Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity

Exclusion Criteria:

1. Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)

2. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted

3. Child who is taking medication for weight loss

4. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)

5. Parent is pregnant or planning on becoming pregnant or lactating during the duration of the study

6. First degree relative or someone in the household with anorexia or bulimia nervosa.

Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Regulation of Cues
ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.
• Family Based Behavioral Treatment
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
• Regulation of Cues +
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
• Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Locations

Country	Name	City	State
United States	UC San Diego Center for Healthy Eating and Activity Research (CHEAR)	La Jolla	California
United States	Ambulatory Research Center - University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child age and sex adjusted body mass index z-score (BMIz)	Age and sex adjusted body mass index (BMI (kg/m^2)) z-score based on the Centers for for Disease Control and Prevention (CDC) norms	Change from baseline at 3 months, 6 months, 12 months, and 18 months
Primary	Child percentage of the 95th percentile BMI (%BMIp95)	Age and Sex specific percentage of the 95th percentile BMI	Change from baseline 3 months, 6 months, 12 months, and 18 months
Primary	Change in Child Overeating episodes	Measured by The Child Eating Disorder Examination (chEDE)	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire	The Food Responsiveness (FR) Scale of the Child Eating Behavior Questionnaire; scores range from 1-5 with higher scores representing greater FR.	Change from baseline at 6 months,12 months, and 18 months]
Secondary	Child Food Cue Responsiveness as measured during exposure to a preferred food	The child will be asked to hold, smell, and taste the highly craved food and rate their current cravings over the course of 5 minutes.	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire	The Satiety Responsiveness (SR) scale of the Child Eating Behavior Questionnaire (CEBQ). Scores range from 1-5 with higher scores representing greater SR.	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Satiety Responsiveness as measured by the Water Load Task (WLT)	The Water Load Task	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Inhibition as measured by the Stop Signal Task	Stop Signal Task with food stimuli	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Inhibition as measured by the Go No Go (GNG) Task	The Go No Go (GNG) task with food stimuli	Change from baseline at 6 months,12 months, and 18 months
Secondary	Child Energy Intake	Automated Self-Administered 24-hour recall (ASA-24)	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Body Mass Index (BMI)	kg/m^2	Change from baseline at 3 months, 6 months,12 months, and 18 months
Secondary	Parent Overeating Episodes	The Eating Disorder Examination (EDE)	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire	Measured by the Food Responsiveness (FR) Scale of the Adult Eating Behavior Questionnaire (AEBQ); scores range from 1-5 with higher scores equating to higher FR.	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Food Cue Responsiveness as measured during exposure to a preferred food	The parent will be asked to hold, smell, and taste the highly craved food and rate their current cravings over the course of 5 minutes.	Change from baseline at 6 months,12 months, and 18 months]
Secondary	Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire	The Satiety Responsiveness Scale of the AEBQ; scores range from 1-5 with higher scores equating to higher SR	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Satiety Responsiveness as measured by the Water Load Task	The Water Load Task	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Inhibition as measured by the Stop Signal Task	Stop Signal Task with food stimuli	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Inhibition as measured by the Go No Go (GNG) Task	The Go No Go (GNG) task with food stimuli.	Change from baseline at 6 months,12 months, and 18 months
Secondary	Parent Energy Intake	Automated Self-Administered 24-hour recall (ASA-24)	Change from baseline at 6 months,12 months, and 18 months