NCT03050840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

February 9, 2017

Last Update Submit

May 9, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    12 weeks

Study Arms (2)

Self-monitoring

OTHER

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

Self-monitoring plus gamification

EXPERIMENTAL

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

Interventions

Way to HealthBEHAVIORAL

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.

Self-monitoringSelf-monitoring plus gamification

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Parks Prout, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

February 13, 2017

Primary Completion

December 4, 2017

Study Completion

January 27, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)