Behavioral Interventions for Type 2 Diabetes

(COMMITTED2-KC Trial)

Overseen By Jared M Bruce, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri, Kansas City

Must not be taking: Short-acting insulin

Disqualifiers: Type 1 diabetes, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people better manage type 2 diabetes. The program combines diabetes coaching and financial rewards with a continuous glucose monitor, a device that tracks blood sugar levels. This Behavioral Intervention involves lifestyle changes and non-pharmacological strategies. Researchers aim to determine if this approach improves adherence to diabetes treatment plans and blood sugar management. Suitable participants have type 2 diabetes, a recent hemoglobin A1c test result between 8.0 and 11.0, and a smartphone compatible with a continuous glucose monitor. Participants will either receive the new program or continue their usual treatment while wearing the glucose monitor. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies without the constraints of traditional drug development phases.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require that you are currently receiving treatment for diabetes from a healthcare provider.

What prior data suggests that this behavioral intervention is safe for individuals with type 2 diabetes?

Research has shown that behavioral treatments for type 2 diabetes are generally safe and manageable. These treatments help individuals with diabetes improve their health habits without causing harm. For instance, smartphone apps delivering these treatments have improved blood sugar levels. In one study, patients experienced a drop in their HbA1c levels, which measures blood sugar control.

Programs that include coaching and lifestyle changes have also helped individuals take their medication regularly and lose weight. These programs typically offer structured feedback and support, making diabetes management easier.

Overall, no strong evidence indicates negative effects from participating in behavioral treatments for diabetes. This suggests these treatments are safe for individuals with type 2 diabetes seeking better health management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the behavioral intervention for type 2 diabetes because it combines financial rewards and personalized coaching to motivate lifestyle changes. Unlike standard treatments that often focus on medication or insulin therapy, this approach uses contingency management and motivational interviewing to encourage healthier behaviors. By integrating continuous glucose monitoring with these strategies, the intervention offers real-time feedback and support, potentially leading to more sustainable improvements in diabetes management.

What evidence suggests that this behavioral intervention is effective for type 2 diabetes?

Research has shown that cognitive behavioral therapy (CBT) can help people manage diabetes more effectively. In one study, CBT improved adherence to medication plans by 16.3% in patients with type 2 diabetes. Another study found that CBT reduced depression and enhanced diabetes self-care and sleep quality. This trial will evaluate a Behavioral Intervention with financial rewards and coaching, incorporating lifestyle changes and coaching, as a method to manage type 2 diabetes. These methods can help control blood sugar levels and improve the overall quality of life for those with diabetes. ^{1 3 6 7 8}

Who Is on the Research Team?

Jared Bruce, PhD

Principal Investigator

University of Missouri, Kansas City

Are You a Good Fit for This Trial?

Adults with type 2 diabetes in Kansas City who are interested in improving their blood sugar management may qualify for this study. Participants should be willing to follow a diabetes treatment plan, use continuous glucose monitoring, and engage with coaching sessions.

Inclusion Criteria

Most recent hemoglobin A1c result between 8.0 and 11.0

Hemoglobin A1c test available within the last 3 months

I am currently being treated for diabetes by a healthcare professional.

Exclusion Criteria

Known or acknowledged active substance use disorder

Type 1 diabetes

I have type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral treatment program including motivational interviewing, contingency management with financial rewards, and continuous glucose monitoring

12 weeks

Regular visits for coaching and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Intervention

Trial Overview The trial is testing a program that combines continuous glucose monitoring with personalized coaching and financial incentives to see if it helps patients better stick to their diabetes treatment plans and manage their blood sugar levels.

How Is the Trial Designed?

Group I: Behavioral Intervention with financial rewards and coaching Experimental Treatment 1 Intervention

Individuals in the treatment group will receive financial rewards (contingency management) and diabetes coaching (motivational interviewing) in addition to wearing a continuous glucose monitor while receiving their usual diabetes treatment.

Group II: Control Active Control 1 Intervention

Individuals in the control group will not receive any interventions and will only wear a continuous glucose monitor while receiving their usual diabetes treatment.

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

Published Research Related to This Trial

Behavioral lifestyle interventions for obesity in individuals with Type 2 diabetes have shown significant and lasting health improvements, highlighting their importance in disease management.

The Look AHEAD intensive lifestyle intervention serves as a successful model for secondary prevention of Type 2 diabetes and obesity, emphasizing the need for behavior change expertise in developing effective weight control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. West, DS., Coulon, SM., Monroe, CM., et al.[2022]

A behavioral intervention combining Social Cognitive Theory-based counseling with technology-based self-monitoring led to a significant reduction in glycated hemoglobin levels in participants with type 2 diabetes, with reductions of 0.5% at 3 months and 0.6% at 6 months.

While both the intervention and control groups showed improvements in glycemic control, there were no significant differences between the two groups, indicating that both approaches may be effective for managing diabetes without one being superior to the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial. Sevick, MA., Korytkowski, M., Stone, RA., et al.[2022]

A 10-week habit formation intervention for 8 adults with Type 2 diabetes showed significant improvements in self-care behaviors for 6 out of 8 participants, indicating that this approach can effectively enhance diabetes management.

The intervention led to a statistically significant increase in habit strength across all self-management areas, including nutrition, blood glucose monitoring, medication management, and physical activity, suggesting that focusing on habit formation can be a promising strategy for diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habit Formation Intervention to Improve Type 2 Diabetes Self-Management Behaviors: A Feasibility Study. Feldhacker, DR., Ikiugu, MN., Fritz, H., et al.[2023]

Chronic stress plays a significant role in the development of insulin resistance and type 2 diabetes, highlighting the need for a new approach to treatment that addresses behavioral factors.

The authors propose a cognitive-behavioral program focused on self-management, motivation, and ongoing education as effective strategies for weight loss and diabetes management, emphasizing the importance of recognizing and treating comorbid psychological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Possibilities of behavior modification in the treatment of diabetes mellitus and obesity]. Sal, I., Papp, I., Perczel Forintos, D.[2018]

Healthy eating and increased physical activity are crucial for preventing or delaying diabetes, and primary care can adapt techniques to help patients adhere to these lifestyle changes.

A coaching approach that includes setting specific goals, regular follow-ups, and a team-based intervention can significantly enhance patient motivation and self-sufficiency in making long-term lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating treatment adherence with lifestyle changes in diabetes. Koenigsberg, MR., Bartlett, D., Cramer, JS.[2006]

Type 2 diabetes affects a significant portion of the American population, with lifestyle interventions being crucial for both initial treatment and ongoing management.

Effective management of type 2 diabetes includes a combination of healthy eating, physical activity, medication, and patient education to help control glucose, lipid levels, and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention: nutrition therapy and physical activity. Evert, AB., Riddell, MC.[2014]

Behavioral programs for adults with type 2 diabetes that include at least 11 contact hours significantly improve glycemic control, with a reduction of 0.4% or more in hemoglobin A1c (HbA1c), while programs with 10 or fewer hours show little benefit.

Participants with higher baseline HbA1c levels (7.0% or greater), those under 65 years old, and minority groups experienced greater reductions in HbA1c, indicating that these subgroups may benefit more from intensive behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. Pillay, J., Armstrong, MJ., Butalia, S., et al.[2022]

In a qualitative study involving 21 adults with type 2 diabetes, participants identified various dietary behavior change techniques (BCTs) like problem-solving and self-monitoring that they used to improve their diets after diagnosis.

Participants also recognized that their dietitians employed effective BCTs such as goal setting and providing instructions, suggesting that dietitians can enhance dietary behavior change by utilizing established behavior change taxonomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyzing Dietary Behaviors Self-reported by People With Diabetes Using a Behavior Change Technique Taxonomy. Rigby, RR., Mitchell, LJ., Hamilton, K., et al.[2022]

A new diagnostic tool was developed for pharmacists to assess diabetes patients' readiness to adhere to diet regimens, utilizing the Transtheoretical Model (TTM) to measure stages of change, decisional balance, and self-efficacy among 193 participants.

The study found that TTM measures effectively identified factors that facilitate or hinder diet adherence, but highlighted the importance of considering social desirability bias in self-reported diet adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision making: strategies for diabetes diet adherence intervention. Kavookjian, J., Berger, BA., Grimley, DM., et al.[2015]

A secondary meta-analysis of 67 randomized controlled trials found that psychological interventions can significantly reduce glycemic levels (HbA1c) in adults with type 2 diabetes, highlighting the importance of these interventions in diabetes management.

The most common behavior change techniques (BCTs) associated with this reduction were 'social support (unspecified)', 'problem solving', and 'goal setting (behavior)', suggesting these techniques could be key components in developing effective psychological interventions for diabetes, although further research is needed to determine the best combinations of BCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Behavior Change Techniques Underpinning Psychological Interventions to Improve Glycemic Levels for Adults With Type 2 Diabetes: A Meta-Analysis. Upsher, R., Onabajo, D., Stahl, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9475282/

The effectiveness of lifestyle interventions on type 2 diabetes ... Comprehensive lifestyle interventions are effective strategies to prevent type 2 diabetes among at-risk populations in LMICs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10351126/

The evaluation of cognitive-behavioral therapy-based ... The CBT-based intervention was beneficial in improving depression symptoms, diabetes self-care behaviors, the efficacy of CBT, and sleep quality in T2DM ...

3. nature.com nature.com/articles/s41598-023-40141-5

Cognitive behavioral therapy for lifestyle changes in ... Patients with type 2 diabetes who participated in CBT treatment reached better medication adherence (16.3% higher medication adherence in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1056872722000794

Effectiveness of cognitive behavioral therapy-based ... RCTs demonstrated an melioration of depressive symptoms, diabetes-related distress and the quality of life in patients with T2DM treated with CBT-based ...

5. diabetesjournals.org diabetesjournals.org/care/article/42/5/841/40473/Randomized-Trial-of-a-Tailored-Cognitive

Randomized Trial of a Tailored Cognitive Behavioral ... This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A1c (HbA1c) in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150315/

Behavioral Lifestyle Interventions for Weight Loss in ... Our findings suggest that structured BLIs, characterized by frequent feedback and support, can lead to a clinically meaningful 5% weight loss.

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038737

Digital Therapeutic Based Randomized Investigation to ... Digital platforms delivering behavioral interventions via smartphones (eg, AspyreRx) have demonstrated reductions in hemoglobin A1c, as well as ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809969

Mobile Health Intervention in Patients With Type 2 Diabetes Results from that study showed an overall decrease in HbA1c of 0.42 to 0.45 percentage points after 1 year, but the addition of a health coach ...