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Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change) (BEST)

Primary Purpose

Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated educational text messages
Autonomy-supportive automated educational text messages
Financial incentives
Tailored text messages
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary Care Provider part of Michigan Medicine
  • Body mass index (BMI) of 25 or higher (23 or higher if of Asian descent)
  • Primary health insurance is U-M Premier Care
  • Recent Hgb (hemoglobin) A1c 5.7 - 6.4% (inclusive)

Exclusion Criteria:

  • Participated in pretesting of intervention materials
  • Diagnosis of type 2 Diabetes Mellitus
  • Serious mental health conditions (described by protocol)
  • End stage renal disease (described by protocol)
  • Alcohol dependence and opioid dependence (described by protocol)
  • Unable to send and receive several text messages weekly
  • No regular access to a smart phone or tablet with data capabilities or Wireless Fidelity (WiFi) connection at home
  • Currently taking metformin
  • Unable to take metformin due to contraindications or side effects
  • Participated in a Diabetes Prevention Program covered by University of Michigan Premier Care insurance
  • Currently enrolled in an interventional research study that is examining how a diet, program, or drug might: promote physical exercise, healthy eating habits, or weight loss; lower blood pressure; or lower blood sugar
  • Not planning to live in local area over the next year
  • Pregnant or planning a pregnancy in the next year
  • Received treatment for an eating disorder (e.g. anorexia or bulimia), not including binge-eating disorder, in last 12 months
  • Intensive cancer treatment such as bone marrow transplant, chemotherapy, radiation, or cancer related surgery (not including hormonal chemotherapy like Tamoxifen) in last six months or near future
  • Organ transplant in last six months
  • Bariatric/ gastric bypass surgery, gastric sleeve surgery, or gastric balloon procedure in last six months
  • Stroke, heart attack, heart surgery, or hospitalization for congestive heart failure in the past three months
  • Other serious health issues or personal concerns that could prevent participant from completing study

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Enhanced Usual Care (EUC)

Financial Incentives

Tailored Messages

Combo Arm-Financial Incentives Plus Tailored Messages Arm

Arm Description

Receives one intervention: automated educational text messages

Receives two interventions: automated educational text messages and financial incentives.

Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.

Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.

Outcomes

Primary Outcome Measures

Change in hemoglobin A1C from baseline to 6 months
Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.
Change in hemoglobin A1C from baseline to 12 months
Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.

Secondary Outcome Measures

Change in weight from baseline to 6 months
Participants will measure their body weight using a scale in their home.
Change in weight from baseline to 12 months
Participants will measure their body weight using a scale in their home.
Engagement in DPP
Health insurance claims will be used to collect this data.
Proportion of days covered by Metformin
Prescription plan claims will be used to collect this data.

Full Information

First Posted
May 21, 2021
Last Updated
October 6, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04902326
Brief Title
Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
Acronym
BEST
Official Title
Integrating Behavioral Economics and Self-Determination Theory to Advance Patient Engagement in Diabetes Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
September 18, 2023 (Actual)
Study Completion Date
September 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients with prediabetes can significantly reduce their risk of developing type 2 diabetes mellitus (T2DM) by participating in a Diabetes Prevention Program (DPP) or using metformin, but very few patients with prediabetes engage in these strategies. This randomized controlled trial will compare, among adults with prediabetes, the effectiveness of financial incentives, tailored messages based on self-determination theory (SDT) principles, and the combination of financial incentives plus tailored messages based on SDT principles in decreasing hemoglobin A1c (HbA1c) and weight and in increasing participation in a DPP or use of metformin. Our main hypotheses are that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives generic health education messages, and that the mean decrease in HbA1c will be greater in the arm that receives a combination of financial incentives plus tailored messages than in the arm that receives financial incentives alone and the arm that receives tailored messages alone. The study will also identify moderators and mediators of the effectiveness of the interventions and evaluate facilitators of and barriers to scalability, acceptability, and sustainability of the different interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
Keywords
Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
All investigators, data analysts, and the project manager will be blinded to arm assignment until primary outcome data are collected
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
Receives one intervention: automated educational text messages
Arm Title
Financial Incentives
Arm Type
Experimental
Arm Description
Receives two interventions: automated educational text messages and financial incentives.
Arm Title
Tailored Messages
Arm Type
Experimental
Arm Description
Receives two interventions: autonomy-supportive automated educational text messages and tailored text messages.
Arm Title
Combo Arm-Financial Incentives Plus Tailored Messages Arm
Arm Type
Experimental
Arm Description
Receives three interventions: autonomy-supportive automated educational text messages, tailored text messages, and financial incentives.
Intervention Type
Behavioral
Intervention Name(s)
Automated educational text messages
Intervention Description
During the first two weeks, participants receive a series of educational messages delivered via text message. These messages welcome participants to the study, set expectations for the next 12 months, and establish a general level of knowledge among all participants on prediabetes, the Diabetes Prevention Program (DPP), and metformin. For the next 11.5 months, participants receive three automated text messages per week that provide evidence-based educational content about prediabetes and tips on prevention. Additionally, participants receive monthly messages reminding them about their health insurance plan's coverage of the DPP at no cost and coverage of metformin as a low co-pay medication, and monthly messages providing feedback on their participation in the DPP and use of metformin in the previous calendar month. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Autonomy-supportive automated educational text messages
Intervention Description
Participants receive the same text messages as in the automated educational text message intervention, but the thrice weekly messages have been modified, where applicable, to support the participant's autonomy, in accordance with principles of Self-Determination Theory. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Intervention Description
Participants in this arm have the opportunity to earn a financial incentive ranging from $50 to $250 per month for taking an evidence-based action to prevent T2DM (i.e., engagement in a DPP or fill of a metformin prescription) in the previous month.
Intervention Type
Behavioral
Intervention Name(s)
Tailored text messages
Intervention Description
Participants receive twice-weekly tailored text messages that link evidence-based actions to prevent T2DM to the participant's self-identified top values, roles, and strengths. Text messages are also tailored, when possible, to participants' self-reported importance of taking action to try to prevent T2DM (i.e., participating in the DPP or taking metformin), confidence in being able to take such preventive action, and past preventive actions taken.
Primary Outcome Measure Information:
Title
Change in hemoglobin A1C from baseline to 6 months
Description
Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.
Time Frame
baseline and 6 months
Title
Change in hemoglobin A1C from baseline to 12 months
Description
Hemoglobin A1C will be tested at clinical lab using blood sample from venipuncture.
Time Frame
baseline and12 months
Secondary Outcome Measure Information:
Title
Change in weight from baseline to 6 months
Description
Participants will measure their body weight using a scale in their home.
Time Frame
baseline and 6 months
Title
Change in weight from baseline to 12 months
Description
Participants will measure their body weight using a scale in their home.
Time Frame
baseline and 12 months
Title
Engagement in DPP
Description
Health insurance claims will be used to collect this data.
Time Frame
up to 12 months
Title
Proportion of days covered by Metformin
Description
Prescription plan claims will be used to collect this data.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary Care Provider part of Michigan Medicine Body mass index (BMI) of 25 or higher (23 or higher if of Asian descent) Primary health insurance is U-M Premier Care Recent Hgb (hemoglobin) A1c 5.7 - 6.4% (inclusive) Exclusion Criteria: Participated in pretesting of intervention materials Diagnosis of type 2 Diabetes Mellitus Serious mental health conditions (described by protocol) End stage renal disease (described by protocol) Alcohol dependence and opioid dependence (described by protocol) Unable to send and receive several text messages weekly No regular access to a smart phone or tablet with data capabilities or Wireless Fidelity (WiFi) connection at home Currently taking metformin Unable to take metformin due to contraindications or side effects Participated in a Diabetes Prevention Program covered by University of Michigan Premier Care insurance Currently enrolled in an interventional research study that is examining how a diet, program, or drug might: promote physical exercise, healthy eating habits, or weight loss; lower blood pressure; or lower blood sugar Not planning to live in local area over the next year Pregnant or planning a pregnancy in the next year Received treatment for an eating disorder (e.g. anorexia or bulimia), not including binge-eating disorder, in last 12 months Intensive cancer treatment such as bone marrow transplant, chemotherapy, radiation, or cancer related surgery (not including hormonal chemotherapy like Tamoxifen) in last six months or near future Organ transplant in last six months Bariatric/ gastric bypass surgery, gastric sleeve surgery, or gastric balloon procedure in last six months Stroke, heart attack, heart surgery, or hospitalization for congestive heart failure in the past three months Other serious health issues or personal concerns that could prevent participant from completing study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kullgren, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified data will be made available after conclusion of the study upon written request to the study team and approval of the Principal Investigator.
IPD Sharing Time Frame
Once study results are posted on this site (by the primary completion date--no later than 12 months after all primary outcome data have been collected), the de-identified data will be available for five years.
IPD Sharing Access Criteria
The de-identified data will be made available after conclusion of the study upon written request to the study team and approval of the Principal Investigator.

Learn more about this trial

Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)

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