Social Incentives to Improve Diabetes

NCT02961192 | Completed

• 1 other identifier: 825372
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II; Diabetes; Obesity

Outcome Measures

Primary Outcomes (3)

• Change in hemoglobin A1c

  Change in hemoglobin A1c from baseline to the end of the one-year study.

  12 months

• Change in weight in pounds

  Change in weight in pounds from baseline to the end of the one-year study.

  12 months

• Change in mean daily steps

  Change in baseline step count compared to the entire one-year study period.

  12 months

Secondary Outcomes (5)

• Change in mean daily steps

  6 months

• Change in weight in pounds from baseline to the study midpoint

  6 months

• Change in hemoglobin A1c from baseline to the study midpoint

  6 months

• Change in LDL-C levels

  6 months

• Change in LDL-C levels

  12 months

Study Arms (4)

Control

NO INTERVENTION

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

Supportive

EXPERIMENTAL

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

Competitive

EXPERIMENTAL

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

Collaborative

EXPERIMENTAL

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

Interventions

Supportive social incentive BEHAVIORAL

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.

Supportive

Competitive social incentive BEHAVIORAL

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

Competitive

Collaborative social incentive BEHAVIORAL

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

Collaborative

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 34028550 DERIVED

• 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.

  PMID: 31746765 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitesh Patel, MD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: February 13, 2017
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)