Behavioral Interventions for Type 2 Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new tool, T2.coach, helps people manage type 2 diabetes. It compares two groups: one receiving regular care and another using T2.coach for six months. The trial focuses on personalizing diabetes management based on individual behavior and blood sugar patterns. People with type 2 diabetes who have been patients at participating health centers for at least six months and regularly attend diabetes education may be a good fit. Participants must have a smartphone and speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies.

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 prior data suggests that this behavioral intervention is safe for managing type 2 diabetes?

Research has shown that the T2.coach program is safe for people with type 2 diabetes. Users have not reported any major safety issues. In one study, participants who followed this health coaching program for over six months experienced health improvements, with blood sugar levels dropping by about 0.57%. This suggests that the program is not only effective but also easy to use over time. Overall, evidence indicates that T2.coach is a safe way to help manage type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about T2.coach because it offers a personalized digital approach to managing Type 2 Diabetes. Unlike traditional treatments that focus solely on medication and standard education, T2.coach integrates tailored behavioral interventions through a digital platform. This innovative method aims to enhance patient engagement and adherence by providing real-time feedback and support, potentially leading to better long-term outcomes. By leveraging technology, T2.coach addresses the daily challenges of diabetes management in a more interactive and supportive way.

What evidence suggests that T2.coach is effective for managing type 2 diabetes?

Studies have shown that blended-care approaches, such as the T2.coach app, effectively manage type 2 diabetes. These studies reported improvements in users' health. In this trial, participants in the T2.coach arm will receive standard care and access to the T2.coach app for 6 months. T2.coach is a mobile app designed to help people manage their diabetes more effectively. Research indicates that apps with online coaching can lead to better blood sugar control. Additionally, users have found T2.coach to be a reliable tool for managing their condition. ^{1 3 6 7 8}

Who Is on the Research Team?

Olena Mamykina, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9161069/

Effectiveness of a personal health coaching intervention ... Blended-care interventions targeting T2D have been found to be effective in multiple studies (d=0.23–0.56). An additional distinctive ...

2. researchgate.net researchgate.net/publication/391239851_T2_Coach_A_Qualitative_Study_of_an_Automated_Health_Coach_for_Diabetes_Self-Management

T2 Coach: A Qualitative Study of an Automated Health ... This paper presents the results of an exploratory qualitative study conducted with nurses on the process of construction/loss of meaning at work ...

3. semanticscholar.org semanticscholar.org/paper/T2-Coach%3A-A-Qualitative-Study-of-an-Automated-Coach-Mitchell-Desai/ca484753837f79c4270bef9f679e8bf30cc1d725

T2 Coach: A Qualitative Study of an Automated Health ... A study with individuals with diabetes and prediabetes who used a CA for health coaching, T2 Coach, revealed that participants saw T2 Coach as reliable in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9445358/

Improving Glycemic Control in Type 2 Diabetes Using Mobile ... According to the MTC analysis using the data from published RCT, mobile apps or apps with e-coaching for T2DM management are more effective in reducing the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02128815

Evaluating the Effect of a Diabetes Health Coach in ... Outcome: The primary outcome is the difference the mean A1C in the diabetes health coaching program, compared to the mean A1C in the control group at 1 year. ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830238

Automated Insulin Delivery in Adults With Type 2 Diabetes In this nonrandomized clinical trial including 305 adults with type 2 diabetes, there was a significant decrease in hemoglobin A 1c (HbA 1c ) levels from 8.2% ...

7. dl.acm.org dl.acm.org/doi/abs/10.1145/3706598.3714404

T2 Coach: A Qualitative Study of an Automated Health ... We conducted a study with sixteen individuals with diabetes and prediabetes who used a CA for health coaching, T2 Coach. Qualitative interviews ...

8. cdc.gov cdc.gov/diabetes-prevention/media/pdfs/T2-Coaches-Handouts-Combined.pdf

Lifestyle Coach Training Guide Prevent T2 is a yearlong lifestyle change program for people at risk of developing type 2 diabetes. Prevent T2 was developed following a comprehensive review of ...