NCT02564445

Brief Summary

This is a 36-week, three-arm randomized, controlled trial using a team-based model to compare two weight loss programs to control. Each intervention will use insights from behavioral economics to leverage social incentives and gamification.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

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

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

September 29, 2015

Last Update Submit

December 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in weight in pounds

    24-week primary intervention period

Secondary Outcomes (3)

  • Change in weight in pounds

    12-week follow-up period

  • Physical activity (mean daily steps)

    24-week primary intervention period

  • Physical activity (mean daily steps)

    12-week follow-up period

Study Arms (3)

Control

EXPERIMENTAL

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts. They will be given information on the federal and CDC guidelines for physical activity and will also be told that they should strive to achieve 10,000 steps per day to help promote weight loss.

Behavioral: Feedback on weightBehavioral: Feedback on step counts

Gamification

EXPERIMENTAL

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts. All participants play a game with their teammate that includes points, levels and the opportunity to win a trophy, plaque or medal. They will advance or not advance based on their progress with weight loss and physical activity through 24 weeks. During the 12-week follow-up they'll be asked to maintain or make progress toward their weight loss goal.

Behavioral: GamificationBehavioral: Feedback on weightBehavioral: Feedback on step counts

Gamification + Share Data with PCP

EXPERIMENTAL

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts. Participants will be asked to allow the study team to share their weight and step data with their primary care physician (PCP). All participants play a game with their teammate that includes points, levels and the opportunity to win a trophy, plaque or medal. They will advance or not advance based on their progress with weight loss and physical activity through 24 weeks. During the 12-week follow-up they'll be asked to maintain or make progress toward their weight loss goal.

Behavioral: GamificationBehavioral: Share Data with PCPBehavioral: Feedback on weightBehavioral: Feedback on step counts

Interventions

GamificationBEHAVIORAL

All participants will be entered with their teammate into a game that includes points and levels

GamificationGamification + Share Data with PCP

Weight and step count data will be shared with the participant's primary care physician

Gamification + Share Data with PCP

Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.

ControlGamificationGamification + Share Data with PCP

Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts

ControlGamificationGamification + Share Data with PCP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years
  • Ability to read and provide informed consent
  • Has an iPhone 4 or newer
  • Have self-reported body mass index of 30 or greater and in-person body mass index of 28 or greater

You may not qualify if:

  • Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English
  • Conditions that would make participation unsafe such as current treatment for drug or alcohol use, myocardial infarction or stroke within the last 6 months, metastatic cancer, pregnant, breastfeeding or plan to become pregnant during study period, previous diagnosis of an eating disorder, or history of unsafe weight loss practices
  • Already enrolled in another weight loss study
  • Any other medical conditions or reasons that they could not complete a 36-week weight loss program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight LossObesityMotor Activity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Mitesh Patel, MD, MBA, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share