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Social Incentives to Improve Diabetes (iDiabetes)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02961192
First received: November 8, 2016
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Type II; Diabetes
Obesity
Behavioral: Supportive social incentive
Behavioral: Competitive social incentive
Behavioral: Collaborative social incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Treatment
Official Title: Using Social Incentives and Patient-Generated Health Data to Change Health Behaviors and Improve Glycemic Control Among Type 2 Diabetics

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Actual Study Start Date: January 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Behavioral: Competitive social incentive
Participants in this intervention will be competing against each other in the game.
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.
Behavioral: Collaborative social incentive
Participants in this intervention will be working with each other in the game.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 30 or greater. However, since the self-report may not be accurate and because weight can fluctuate, when they arrive for the in-person baseline weigh-in they will be allowed to participate if their BMI is 28 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02961192

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Mitesh Patel, MD, MBA University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02961192     History of Changes
Other Study ID Numbers: 825372
Study First Received: November 8, 2016
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017