Clinical trial NCT06207110: Family, Responsibility, Education, Support, and Health for Food Responsiveness
Official title: Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: Food Responsiveness
Satiety Responsiveness
Weight Loss
Overeating
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-16
Enrollment: 280
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility criteria: 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 3.8 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 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. 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.

Primary outcomes:
measure: Child age and sex adjusted body mass index z-score (BMIz)
timeFrame: Change from baseline at 3 months, 6 months, 12 months, and 18 months
measure: Child percentage of the 95th percentile BMI (%BMIp95)
timeFrame: Change from baseline 3 months, 6 months, 12 months, and 18 months
measure: Change in Child Overeating
timeFrame: Change from baseline at 6 months,12 months, and 18 months
Secondary outcomes:
measure: Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire
timeFrame: Change from baseline at 6 months,12 months, and 18 months]
measure: Child Food Cue Responsiveness as measured during exposure to a preferred food
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Child Satiety Responsiveness as measured by the Water Load Task (WLT)
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Child Inhibition as measured by the Stop Signal Task
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Child Inhibition as measured by the Go No Go (GNG) Task
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Child Energy Intake
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Body Mass Index (BMI)
timeFrame: Change from baseline at 3 months, 6 months,12 months, and 18 months
measure: Parent Overeating
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Food Cue Responsiveness as measured during exposure to a preferred food
timeFrame: Change from baseline at 6 months,12 months, and 18 months]
measure: Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Satiety Responsiveness as measured by the Water Load Task
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Inhibition as measured by the Stop Signal Task
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Inhibition as measured by the Go No Go (GNG) Task
timeFrame: Change from baseline at 6 months,12 months, and 18 months
measure: Parent Energy Intake
timeFrame: Change from baseline at 6 months,12 months, and 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
state: California
city: Minneapolis
country: United States
facility: Ambulatory Research Center - University of Minnesota
state: Minnesota
Study officials:
affiliation: UC San Diego
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: