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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK135599 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regulation of Cues | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness. |
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| Family-Based Treatment | Active Comparator | The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance. |
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| Regulation of Cues + | Experimental | The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake |
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| Health Education | Active Comparator | The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. | Change from baseline at 6 months,12 months, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Child Food Cue Responsiveness as measured during exposure to a preferred food |
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Inclusion Criteria:
Exclusion Criteria:
Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaylen Moline, MPH | Contact | 1-855-827-3498 | chear@ucsd.edu | |
| Kerri Boutelle, Ph.D. | Contact | 858-249-3528 | kboutelle@ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kerri Boutelle, Ph.D. | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Center for Healthy Eating and Activity Research (CHEAR) | Recruiting | La Jolla | California | 92037 | United States |
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| Label | URL |
|---|---|
| Learn more on our study webpage | View source |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Family Based Behavioral Treatment | Behavioral | FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance. |
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| Regulation of Cues + | Behavioral | ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake |
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| Health Education | Behavioral | The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Child Energy Intake | Automated Self-Administered 24-hour recall (ASA-24) | Change from baseline at 6 months,12 months, and 18 months |
| Parent Body Mass Index (BMI) | kg/m^2 | Change from baseline at 3 months, 6 months,12 months, and 18 months |
| Parent Overeating | Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger. | Change from baseline at 6 months,12 months, and 18 months |
| 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 |
| 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] |
| 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 |
| 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 |
| 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 |
| 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 |
| Parent Energy Intake | Automated Self-Administered 24-hour recall (ASA-24) | Change from baseline at 6 months,12 months, and 18 months |
| Ambulatory Research Center - University of Minnesota | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D012817 | Signs and Symptoms, Digestive |