Clinical trial NCT04902326: Behavioral Economics and Self-Determination Theory to Change Diabetes Risk (BEST Change)
Official title: Integrating Behavioral Economics and Self-Determination Theory to Advance Patient Engagement in Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Keywords: Prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Hemoglobin A1c From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Hemoglobin A1c From Baseline to 12 Months
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Change in Weight From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Weight From Baseline to 12 Months
timeFrame: baseline to 12 months
measure: Engagement in Diabetes Prevention Program or Use of Metformin
timeFrame: Months 2-12 of participation in the study
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey Kullgren, MD
role: PRINCIPAL_INVESTIGATOR
References: