Health TrialsbyHealthPanel

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

ConditionObesity, Childhood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorUniversity of California, San Diego

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Family Based Behavioral Treatment

    Behavioral

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

  • Regulation of Cues +

    Behavioral

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

  • Health Education

    Behavioral

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

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: Regulation of CuesExperimental treatment 1 intervention
Group B: Family-Based TreatmentActive comparator 1 intervention
Group C: Regulation of Cues +Experimental treatment 1 intervention
Group D: Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Change from baseline at 3 months, 6 months, 12 months, and 18 months
2

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

Age and Sex specific percentage of the 95th percentile BMI

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

Change in Child Overeating

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.

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

Secondary outcomes

1

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.

Time frame
Change from baseline at 6 months,12 months, and 18 months]
2

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.

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

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.

Time frame
Change from baseline at 6 months,12 months, and 18 months
4

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

The Water Load Task

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

University of Minnesota

Collaborator

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

Collaborator

Source ClinicalTrials.gov
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