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Social Incentives to Improve Diabetes (iDiabetes)

Primary Purpose

Type II; Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive social incentive
Competitive social incentive
Collaborative social incentive
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type II; Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Supportive

Competitive

Collaborative

Arm Description

Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c
Change in hemoglobin A1c from baseline to the end of the one-year study.
Change in weight in pounds
Change in weight in pounds from baseline to the end of the one-year study.
Change in mean daily steps
Change in baseline step count compared to the entire one-year study period.

Secondary Outcome Measures

Change in mean daily steps
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
Change in weight from baseline to the six-month midpoint of the study
Change in hemoglobin A1c from baseline to the study midpoint
Change in hemoglobin A1c to the six-month midpoint of the study
Change in LDL-C levels
Change in LDL-C from baseline to the six-month midpoint of the study
Change in LDL-C levels
Change in LDL-C from baseline to the end of the one-year study.

Full Information

First Posted
November 8, 2016
Last Updated
September 14, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02961192
Brief Title
Social Incentives to Improve Diabetes
Acronym
iDiabetes
Official Title
Using Social Incentives and Patient-Generated Health Data to Change Health Behaviors and Improve Glycemic Control Among Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II; Diabetes, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive a wireless weight scale and a wearable activity tracker to monitor their weight and step counts.
Arm Title
Supportive
Arm Type
Experimental
Arm Description
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.
Arm Title
Competitive
Arm Type
Experimental
Arm Description
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.
Arm Title
Collaborative
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Supportive social incentive
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Competitive social incentive
Intervention Description
Participants in this intervention will be competing against each other in the game.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative social incentive
Intervention Description
Participants in this intervention will be working with each other in the game.
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c
Description
Change in hemoglobin A1c from baseline to the end of the one-year study.
Time Frame
12 months
Title
Change in weight in pounds
Description
Change in weight in pounds from baseline to the end of the one-year study.
Time Frame
12 months
Title
Change in mean daily steps
Description
Change in baseline step count compared to the entire one-year study period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in mean daily steps
Description
Change in baseline step count compared to the first 6 months of the study period
Time Frame
6 months
Title
Change in weight in pounds from baseline to the study midpoint
Description
Change in weight from baseline to the six-month midpoint of the study
Time Frame
6 months
Title
Change in hemoglobin A1c from baseline to the study midpoint
Description
Change in hemoglobin A1c to the six-month midpoint of the study
Time Frame
6 months
Title
Change in LDL-C levels
Description
Change in LDL-C from baseline to the six-month midpoint of the study
Time Frame
6 months
Title
Change in LDL-C levels
Description
Change in LDL-C from baseline to the end of the one-year study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years to 70 years Ability to read and provide informed consent to participate in the study Diagnosis of type 2 diabetes with a hemoglobin A1c of 8.0 or greater Self-reported body mass index (BMI) of 25 or greater. Smartphone or tablet compatible with the application for the wearable activity tracking device and wireless weight scale. Exclusion Criteria: 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 pregnancy, previous diagnosis of an eating disorder, or history of unsafe weight loss practices Already enrolled in another study targeting physical activity, weight loss, or glycemic control Any other medical conditions or reasons he or she is unable to participate in the study for one year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh Patel, MD, MBA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34028550
Citation
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.
Results Reference
derived
PubMed Identifier
31746765
Citation
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.
Results Reference
derived

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Social Incentives to Improve Diabetes

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