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Social Incentives to Improve Diabetes

Using Social Incentives and Patient-Generated Health Data to Change Health Behaviors and Improve Glycemic Control Among Type 2 Diabetics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02961192
Acronym
iDiabetes
Enrollment
361
Registered
2016-11-10
Start date
2017-02-13
Completion date
2020-01-27
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type II; Diabetes

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.

Interventions

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.

Participants in this intervention will be competing against each other in the game.

Participants in this intervention will be working with each other in the game.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in hemoglobin A1c12 monthsChange in hemoglobin A1c from baseline to the end of the one-year study.
Change in weight in pounds12 monthsChange in weight in pounds from baseline to the end of the one-year study.
Change in mean daily steps12 monthsChange in baseline step count compared to the entire one-year study period.

Secondary

MeasureTime frameDescription
Change in mean daily steps6 monthsChange in baseline step count compared to the first 6 months of the study period
Change in LDL-C levels6 monthsChange in LDL-C from baseline to the six-month midpoint of the study
Change in weight in pounds from baseline to the study midpoint6 monthsChange in weight from baseline to the six-month midpoint of the study
Change in hemoglobin A1c from baseline to the study midpoint6 monthsChange in hemoglobin A1c to the six-month midpoint of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026