Social Incentives to Improve Diabetes

Obesity Clinical Trial

— iDiabetes  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961192
• Other study ID #: 825372
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: January 27, 2020

Study information

• Verified date: September 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type II; Diabetes

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.
• Competitive social incentive
Participants in this intervention will be competing against each other in the game.
• Collaborative social incentive
Participants in this intervention will be working with each other in the game.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin A1c	Change in hemoglobin A1c from baseline to the end of the one-year study.	12 months
Primary	Change in weight in pounds	Change in weight in pounds from baseline to the end of the one-year study.	12 months
Primary	Change in mean daily steps	Change in baseline step count compared to the entire one-year study period.	12 months
Secondary	Change in mean daily steps	Change in baseline step count compared to the first 6 months of the study period	6 months
Secondary	Change in weight in pounds from baseline to the study midpoint	Change in weight from baseline to the six-month midpoint of the study	6 months
Secondary	Change in hemoglobin A1c from baseline to the study midpoint	Change in hemoglobin A1c to the six-month midpoint of the study	6 months
Secondary	Change in LDL-C levels	Change in LDL-C from baseline to the six-month midpoint of the study	6 months
Secondary	Change in LDL-C levels	Change in LDL-C from baseline to the end of the one-year study.	12 months