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Gamification and Energetic Behavior Changes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050840
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Way to Health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gamification and Energetic Behavior Changes in Adolescent-Parent Dyads With Obesity
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : January 27, 2018

Arm Intervention/treatment
Self-monitoring
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
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.

Experimental: Self-monitoring plus gamification
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
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050840


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
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Principal Investigator: Elizabeth Parks Prout, MD Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03050840    
Other Study ID Numbers: 16-013613
1UL1TR001878-01 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms