Social Incentives to Improve Diabetes (iDiabetes)

• ClinicalTrials.gov Identifier: NCT02961192
• Recruitment Status: Completed
• First Posted: November 10, 2016
• Last Update Posted: September 16, 2021
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: November 8, 2016
• First Posted Date: November 10, 2016
• Last Update Posted Date: September 16, 2021
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: January 27, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2016)

• Change in hemoglobin A1c [ Time Frame: 12 months ]
  Change in hemoglobin A1c from baseline to the end of the one-year study.
• Change in weight in pounds [ Time Frame: 12 months ]
  Change in weight in pounds from baseline to the end of the one-year study.
• Change in mean daily steps [ Time Frame: 12 months ]
  Change in baseline step count compared to the entire one-year study period.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 8, 2016)

• Change in mean daily steps [ Time Frame: 6 months ]
  Change in baseline step count compared to the first 6 months of the study period
• Change in weight in pounds from baseline to the study midpoint [ Time Frame: 6 months ]
  Change in weight from baseline to the six-month midpoint of the study
• Change in hemoglobin A1c from baseline to the study midpoint [ Time Frame: 6 months ]
  Change in hemoglobin A1c to the six-month midpoint of the study
• Change in LDL-C levels [ Time Frame: 6 months ]
  Change in LDL-C from baseline to the six-month midpoint of the study
• Change in LDL-C levels [ Time Frame: 12 months ]
  Change in LDL-C from baseline to the end of the one-year study.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Social Incentives to Improve Diabetes
• Official Title: Using Social Incentives and Patient-Generated Health Data to Change Health Behaviors and Improve Glycemic Control Among Type 2 Diabetics
• Brief Summary: In this study, we will conduct a one-year, four-arm, randomized, controlled trial to compare three social incentive-based gamification interventions to control for promoting physical activity and weight loss toward improved glycemic control among type 2 diabetics.

Detailed Description

This is a four-arm, one-year randomized, controlled trial. The study will be conducted using Way to Health, an automated information technology platform at the University of Pennsylvania that integrates wireless devices, conducts clinical trial randomization and enrollment processes, delivers messaging (text or email) delivers self-administered surveys, automates payment transfers, and securely captures data for research purposes.

The study team will identify potential participants from the electronic health record at the University of Pennsylvania Health System. Interested participants will be instructed to visit the study website to create an account, review and complete informed consent, and complete an eligibility survey. Eligible participants will be instructed to obtain a hemoglobin A1c and LDL-C laboratory test. If the hemoglobin A1c is 8.0 or greater and the participant is still interested in continuing the enrollment process, a wearable activity tracking device will be mailed to them. After that, the participant will be scheduled for an in-person visit with the study team to complete the enrollment process.

Participants will be randomly assigned in blocks of four groups to one of the four study arms stratified based on whether the group of individuals already knew each other or not. Groups will have three individuals unless the individuals were already socially connected prior to the study, in which case they will be allowed to be randomized as a group of two or three. Participants randomized to the control arm will receive no other interventions.

Each participant in the intervention arms will be asked to choose their goals for the study as follows: 1) Choose a weight loss goal that is 6%, 7%, or 8% of their baseline weight rounded up to the next pound; 2) Choose a daily step count goal that is 33%, 40%, or 50% greater than their baseline rounded up to the nearest hundred, or choose their own step goal as long as it is at least 1500 steps above their baseline; 3) Choose a HbA1c reduction goal of 1.5%, 2%, or 2.5%.

Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. On a daily basis, they will be asked to weigh-in. They will have a weekly weight target and mean step goal. Weekly feedback will differ among the three arms to induce the different social incentives.

The primary outcome variables are change in mean daily steps, weight in pounds, and hemoglobin A1c from baseline to end of the one-year study.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Health Services Research

Condition

• Type II; Diabetes
• Obesity

Intervention

• Behavioral: Supportive social incentive
  A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
• Behavioral: Competitive social incentive
  Participants in this intervention will be competing against each other in the game.
• Behavioral: Collaborative social incentive
  Participants in this intervention will be working with each other in the game.

Study Arms

• No Intervention: Control
  Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts.
• Experimental: Supportive
  Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts. Additionally, participants will play a game designed with insights from behavioral economics. The game will involve points and levels. In addition to playing the game, participants will identify a family member or friend to receive updates and support them in their progress.
  Intervention: Behavioral: Supportive social incentive
• Experimental: Competitive
  Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts. Additionally, participants will play a game designed with insights from behavioral economics. The game will involve points and levels. In this arm, participants will be placed into competitive groups with one or two other participants to play the game.
  Intervention: Behavioral: Competitive social incentive
• Experimental: Collaborative
  Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts. Additionally, participants will play a game designed with insights from behavioral economics. The game will involve points and levels. In this arm, participants will be placed into collaborative groups with one or two other participants to play the game.
  Intervention: Behavioral: Collaborative social incentive

Publications *

• Patel MS, Small DS, Harrison JD, Hilbert V, Fortunato MP, Oon AL, Rareshide CAL, Volpp KG. Effect of Behaviorally Designed Gamification With Social Incentives on Lifestyle Modification Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e2110255. doi: 10.1001/jamanetworkopen.2021.10255.
• Fortunato M, Harrison J, Oon AL, Small D, Hilbert V, Rareshide C, Patel M. Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 20;8(11):e14180. doi: 10.2196/14180.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 9, 2019): 361
• Original Estimated Enrollment (submitted: November 8, 2016): 360
• Actual Study Completion Date: January 27, 2020
• Actual Primary Completion Date: January 27, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age 18 years to 70 years
2. Ability to read and provide informed consent to participate in the study
3. Diagnosis of type 2 diabetes with a hemoglobin A1c of 8.0 or greater
4. Self-reported body mass index (BMI) of 25 or greater.
5. Smartphone or tablet compatible with the application for the wearable activity tracking device and wireless weight scale.

Exclusion Criteria:

1. Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English
2. Conditions that would make participation unsafe such as pregnancy, previous diagnosis of an eating disorder, or history of unsafe weight loss practices
3. Already enrolled in another study targeting physical activity, weight loss, or glycemic control
4. Any other medical conditions or reasons he or she is unable to participate in the study for one year.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02961192
• Other Study ID Numbers: 825372
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Pennsylvania
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pennsylvania
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mitesh Patel, MD, MBA; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: September 2021