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NCT Number: NCT06207110

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

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).

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego Center for Healthy Eating and Activity Research (CHEAR), La Jolla, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed assent and parental consent
  • A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
  • Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.
  • 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
  • Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
  • Child is on stable medication regimen for medications that can impact weight (3+ months)
  • 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

  • Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
  • 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
  • Child who is taking medication for weight loss
  • Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
  • 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.

Treatment and study plan

Regulation of Cues

Behavioral

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.

Other names: ROC

Family Based Behavioral Treatment

Behavioral

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

Other names: FBT

Regulation of Cues +

Behavioral

ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake

Other names: ROC+

Health Education

Behavioral

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

Other names: HE

Primary outcomes

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

    Time frame: Change from baseline at 3 months, 6 months, 12 months, and 18 months

    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

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

    Time frame: Change from baseline 3 months, 6 months, 12 months, and 18 months

    Age and Sex specific percentage of the 95th percentile BMI

  3. Change in Child Overeating

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Measured by The Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.

Secondary outcomes

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

    Time frame: Change from baseline at 6 months,12 months, and 18 months]

    The Food Responsiveness (FR) Scale of the Child Eating Behavior Questionnaire; scores range from 1-5 with higher scores representing greater FR.

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

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    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.

  3. Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Satiety Responsiveness (SR) scale of the Child Eating Behavior Questionnaire (CEBQ). Scores range from 1-5 with higher scores representing greater SR.

  4. Child Satiety Responsiveness as measured by the Water Load Task (WLT)

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Water Load Task

  5. Child Inhibition as measured by the Stop Signal Task

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Stop Signal Task with food stimuli

  6. Child Inhibition as measured by the Go No Go (GNG) Task

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Go No Go (GNG) task with food stimuli

  7. Child Energy Intake

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Automated Self-Administered 24-hour recall (ASA-24)

  8. Parent Body Mass Index (BMI)

    Time frame: Change from baseline at 3 months, 6 months,12 months, and 18 months

    kg/m^2

  9. Parent Overeating

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.

  10. Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    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.

  11. Parent Food Cue Responsiveness as measured during exposure to a preferred food

    Time frame: Change from baseline at 6 months,12 months, and 18 months]

    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.

  12. Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Satiety Responsiveness Scale of the AEBQ; scores range from 1-5 with higher scores equating to higher SR

  13. Parent Satiety Responsiveness as measured by the Water Load Task

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Water Load Task

  14. Parent Inhibition as measured by the Stop Signal Task

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Stop Signal Task with food stimuli

  15. Parent Inhibition as measured by the Go No Go (GNG) Task

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    The Go No Go (GNG) task with food stimuli.

  16. Parent Energy Intake

    Time frame: Change from baseline at 6 months,12 months, and 18 months

    Automated Self-Administered 24-hour recall (ASA-24)

Study contacts

Contact information is provided by the study sponsor or research team.

Kaylen Moline, MPH

CONTACT

[email protected]

1-855-827-3498

Kerri Boutelle, Ph.D.

CONTACT

[email protected]

858-249-3528

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Minnesota

Registry information

Official study title

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

Acronym: FRESH-FR

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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