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OpenTrials
Completed

NCT Number: NCT03050840

Gamification and Energetic Behavior Changes

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Way to Health

Behavioral

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.

Primary outcomes

  1. Difference in the total number of steps per day

    Time frame: 12 weeks

    Fitbit estimated steps per day will be compared between the two treatment groups at the end of the treatment period

Secondary outcomes

  1. Difference in the total number of sugar sweetened beverages consumed per day

    Time frame: 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 13, 2017
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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