Behavioral Interventions for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Jonathan Tobin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnant, Cognitive impairment, Serious illnesses, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

280 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on behavioral interventions, so you may not need to change your medication routine.

What data supports the effectiveness of the treatment T2.coach for Type 2 Diabetes?

Research shows that behavioral interventions like health coaching and motivational interviewing can help people with Type 2 diabetes manage their condition better. A study found that regular telephone coaching improved diet, exercise, and reduced symptoms in diabetes patients, suggesting that similar approaches like T2.coach could be effective. ^{1 2 3 4 5}

Is health coaching for type 2 diabetes safe for humans?

The research on health coaching for type 2 diabetes, including programs like T2.coach, does not report any safety concerns, suggesting it is generally safe for humans. ^{2 4 6 7 8}

How is the T2.coach treatment different from other treatments for type 2 diabetes?

T2.coach is unique because it likely involves a digital or behavioral coaching approach, similar to interventions like motivational interviewing and digital health coaching, which focus on personalized support for lifestyle changes such as physical activity and diet, rather than traditional medication. ^{2 4 9 10 11}

What is the purpose of this trial?

In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.

Research Team

Olena Mamykina, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults aged 18-65 with type 2 diabetes, an HbA1c level of at least 8.0, who own a mobile phone and speak English or Spanish. They must be patients at the health center for over six months and attend its diabetes education program. Those with severe cognitive issues, pregnancy, participation in similar past trials, serious illnesses like advanced cancer or heart failure, or plans to leave the health center within a year cannot join.

Inclusion Criteria

HbA1c ≥ 8.0,

Owns a basic mobile phone

Proficient in either English or Spanish

Exclusion Criteria

Presence of severe cognitive impairment (recorded in patient chart)

Pregnant

Participation in the previous trial of diabetes self-management technologies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard diabetes education and the experimental group uses T2.coach for 6 months

6 months

Regular visits as per FQHC schedule

Follow-up

Participants are monitored for changes in diabetes self-efficacy, problem-solving, and HbA1c levels

6 months

Assessments at baseline, 6 months, and 12 months

Treatment Details

Interventions

• T2.coach

Trial Overview The study tests T2.coach's effectiveness in personalizing self-management for type 2 diabetes based on behavioral and glycemic profiles against usual care alone. It's a randomized controlled trial involving 280 participants from Federally Qualified Health Centers (FQHCs), split evenly between control and experimental groups.

Participant Groups

Group I: T2.coach Experimental Treatment 1 Intervention

Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months.

Group II: Control Active Control 1 Intervention

Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Clinical Directors Network

Collaborator

Trials

13

Recruited

14,200+

Findings from Research

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]

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 12-month telephone diabetes health coaching (DHC) intervention significantly improved glycemic control in adults with type 2 diabetes, reducing A1C levels by 1.8% compared to 1.3% in the usual diabetes education group.

Participants receiving DHC also reported better quality of life, as indicated by improved scores on the Audit of Diabetes-Dependent Quality of Life (ADDQoL-19), with no increase in emergency department visits or hospitalizations, suggesting the intervention is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial. Sherifali, D., Brozic, A., Agema, P., et al.[2021]

The E-Supporter 1.0 digital coach was found to be an acceptable and user-friendly intervention for promoting a healthier lifestyle among 20 individuals with type 2 diabetes (T2D), with participants appreciating its motivational support and ease of use.

Participants showed significant improvements in daily step counts and self-efficacy levels after 9 weeks of using E-Supporter 1.0, although the intervention's impact on dietary behavior and the phase of behavior change was limited, indicating a need for further tailoring and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Coach (E-Supporter 1.0) to Support Physical Activity and a Healthy Diet in People With Type 2 Diabetes: Acceptability and Limited Efficacy Testing. Hietbrink, EAG., Oude Nijeweme-d'Hollosy, W., Middelweerd, A., et al.[2023]

References

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

KMAP-O framework for care management research of patients with type 2 diabetes. [2020]

2. 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]

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

Effect of a brief, regular telephone intervention by paraprofessionals for type 2 diabetes. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Applying the RE-AIM implementation framework to evaluate diabetes health coaching in individuals with type 2 diabetes: A systematic review and secondary analysis. [2023]

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a Health Coach Intervention for the Management of Individuals With Type 2 Diabetes Mellitus in China: A Pragmatic Cluster Randomized Controlled Trial. [2023]

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

Health Coaching for Patients With Type 2 Diabetes Mellitus to Decrease 30-Day Hospital Readmissions. [2019]

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

Effectiveness of motivational interviewing for improving physical activity self-management for adults with type 2 diabetes: A review. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

A Digital Coach (E-Supporter 1.0) to Support Physical Activity and a Healthy Diet in People With Type 2 Diabetes: Acceptability and Limited Efficacy Testing. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Behavioral strategies in diabetes prevention programs: a systematic review of randomized controlled trials. [2022]