Gamification and Energetic Behavior Changes

Study Overview
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Brief Summary
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Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile or ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and physical activity, but change in these behaviors requires self-monitoring and support, and weight loss is not always successful. Parent involvement and parent weight-loss can help their children to lose weight and successfully change their behavior. Guidance from pediatricians can also help to facilitate weight loss among obese adolescents. That said, treatment of obesity through behavior change within the time constraints of a Pediatric practice visit is limited by treatment adherence and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep adolescents with severe obesity engaged in therapy outside of standard practice is a critical need. The effects of monetary incentives through games (gamification), and a comprehensive remote digital monitoring system on sleep, physical activity, and dietary intake, has been successful in adults, but has not been tested in adolescents with obesity.

Official Title
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Gamification and Energetic Behavior Changes in Adolescent-Parent Dyads With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Way to Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child Subjects age 10 - 16 Obese as defined by body mass index (BMI) Computer access and data plan with text messaging SSB intake of 2 or more servings per day (1 serving=12oz) Exclusion Criteria: Active substance abuse. Syndromic or secondary obesity. Any developmental disorder. Eating disorder (with the exception of binge eating disorder). Psychosis. Untreated depression. Use of medications (prescription or otherwise) known to effect body weight. Weight loss of more than 5% body weight in the past 3 months. History of bariatric surgery.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 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 |
| --- | --- |
| Other: Self-monitoring<br>Participants will wear a Fitbit, to self-monitor steps per day, and will report sugar sweetened beverage (SSB) consumption via text messaging. The Way to Health platform will record data. | Behavioral: Way to Health<br>* An online platform (Way to Health) will be used to test if self-monitoring plus gamification principles can increase steps per day and lower sugar sweetened beverage consumption per day, among obese children and adults, compared to self-monitoring alone.<br>|
| Experimental: Self-monitoring plus gamification<br>Participants will wear a Fitbit, to self-monitor steps per day, and will report sugar sweetened beverage consumption via text messaging. Participants will be awarded medals and points based on meeting step per day and SSB consumption goals The Way to Health platform will be used to record data. | Behavioral: Way to Health<br>* An online platform (Way to Health) will be used to test if self-monitoring plus gamification principles can increase steps per day and lower sugar sweetened beverage consumption per day, among obese children and adults, compared to self-monitoring alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the total number of steps per day | Fitbit estimated steps per day will be compared between the two treatment groups at the end of the treatment period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the total number of sugar sweetened beverages consumed per day | Self-reported sugar sweetened beverage consumption per day via automated text messaging and compared between the two groups at the end of the treatment period | 12 weeks |