Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02961192 |
Other study ID # |
825372 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.