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

Trial Summary

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 data supports the effectiveness of this treatment for Type 2 Diabetes?

Research shows that behavioral and lifestyle interventions can help people with Type 2 Diabetes manage their condition better. These treatments, which include healthy eating and physical activity, have been shown to improve health outcomes and help with weight management, which is important for controlling diabetes. ^{1 2 3 4 5}

Is behavioral intervention for Type 2 diabetes safe for humans?

Behavioral interventions, such as lifestyle changes involving healthy eating and increased physical activity, are generally safe for humans and can lead to meaningful health improvements in managing Type 2 diabetes. ^{1 3 6 7 8}

How is the Behavioral Intervention treatment for Type 2 Diabetes different from other treatments?

Behavioral Intervention for Type 2 Diabetes focuses on changing lifestyle habits and self-management behaviors rather than using medication. It emphasizes forming healthy habits, managing stress, and ongoing education to improve health outcomes, which is different from traditional drug treatments that primarily target blood sugar levels. ^{1 3 7 9 10}

What is the purpose of this trial?

This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.

Research Team

Jared Bruce, PhD

Principal Investigator

University of Missouri, Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient decision making: strategies for diabetes diet adherence intervention. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based lifestyle interventions for obesity and Type 2 diabetes: The Look AHEAD intensive lifestyle intervention as exemplar. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Lifestyle intervention: nutrition therapy and physical activity. [2014]

5. Switzerland 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Analyzing Dietary Behaviors Self-reported by People With Diabetes Using a Behavior Change Technique Taxonomy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Facilitating treatment adherence with lifestyle changes in diabetes. [2006]

9. Hungary pubmed.ncbi.nlm.nih.gov

[Possibilities of behavior modification in the treatment of diabetes mellitus and obesity]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Habit Formation Intervention to Improve Type 2 Diabetes Self-Management Behaviors: A Feasibility Study. [2023]