Skills Training Within a Family-based Obesity Treatment Intervention

Study Overview
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Brief Summary
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This study is investigating the impact of a skills training program in stimulus control of meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity treatment intervention with education on child health or a standard family-based obesity treatment intervention with experiential learning about meal stimulus control strategies.

Detailed Description
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Family-based obesity treatment interventions can successfully reduce weight in children, but are often limited in the practice of skills being taught during treatment sessions. Skills training focused on a particular behavioral strategy can provide parents with an experiential component of learning where the information learned as part of a family-based obesity treatment intervention is also practiced. Health education simply provides knowledge to a family about a topic.

Official Title
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Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: child health education
* Behavioral: skills training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: caregiver of child is ≥18 years of age; the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile); the caregiver and child are able to read, speak and understand English due to delivery of the program in English; has transportation to the University of Delaware; and is willing and able to commit to the 3-month study. Exclusion Criteria: the child has a medical condition impacting physical activity or eating (e.g. Type 1 or Type 2 diabetes); the child have a medical condition that affects growth (e.g. Prader Willi Syndrome); the child is currently participating in a weight management program, and/or taking weight loss medication; or the caregiver or child has an inability to participate in regular physical activity.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Child Health Education<br>The child health education condition will participate in a family-based obesity treatment program for the first 40 minutes of each session, followed by 20 minutes designated to education about a child health topic. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. | Behavioral: child health education<br>* 10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of education about a child health topic.<br>|
| Experimental: Skills Training<br>The skills training condition will participate in a family-based obesity treatment program for the first 40 minutes of each session followed by 20 minutes of experiential learning about meal stimulus control strategies. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. In addition they will self-monitor the use the following stimulus control strategies: portion control, energy density and variety. | Behavioral: skills training<br>* 10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of experiential learning about stimulus control strategies (portion size, energy density, variety).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| z-BMI | Height and weight will be used to calculate BMI (kg/m2) and BMI will be standardized in relation to the population mean and standard deviation for the child's age to sex to determine zBMI. | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake | Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days. | 3-months | 
| Percent Energy from Fat | Based upon a 3-day dietary record analyzed using NDS-R, the calories from fat will be divided by total energy intake (calories) to get percentage energy from fat. | 3-months | 
| Food groups servings | Based upon a 3-day dietary record analyzed using NDS-R, the number of servings consumed from each food group will be averaged over three days. | 3-months | 
| Physical Activity | Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR. | 3-months |