Motivational Interviews for Sedentary Lifestyle in Diabetes and Prediabetes

(EPPC Trial)

Overseen By Melissa Preciado, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must not be taking: Insulin

Disqualifiers: Cardiovascular event, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

451 Participants Needed

Trial Summary

What is the purpose of this trial?

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.

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 mainly focuses on increasing physical activity for those with diabetes or prediabetes who are not using insulin.

What data supports the effectiveness of the treatment Telephone-based motivational interviews for sedentary lifestyle in diabetes and prediabetes?

Research shows that motivational interviewing, a technique used in telephone-based interventions, can help improve blood sugar control in people with type 2 diabetes. Additionally, telephone coaching has been effective in supporting lifestyle changes, especially in diverse and low-income groups, which can be beneficial for managing diabetes and prediabetes. ^{1 2 3 4 5}

Is motivational interviewing safe for humans?

Motivational interviewing, including telephone-based health coaching, is generally considered safe for humans as it involves conversations aimed at encouraging positive behavior changes without physical interventions. ^{6 7 8 9 10}

How does the treatment of telephone-based motivational interviews for sedentary lifestyle in diabetes and prediabetes differ from other treatments?

Telephone-based motivational interviews are unique because they focus on encouraging positive behavior changes through personalized conversations over the phone, which can be particularly effective for people with low socioeconomic status or diverse backgrounds. This approach is different from traditional treatments that may not address individual barriers to lifestyle changes, such as motivation and access to resources. ^{1 4 11 12 13}

Eligibility Criteria

This trial is for Kaiser Permanente members at Fontana Medical Center who have prediabetes or diabetes (not on insulin), speak English or Spanish, have a BMI of 18.5-40, and exercise less than 30 minutes per week. It's not for pregnant women, those in other studies, planning to move soon, using insulin, or with recent heart issues.

Inclusion Criteria

Able to speak English or Spanish

Receives primary care at the Fontana Medical Center

Kaiser Permanente member for at least 12 months

Exclusion Criteria

Pregnancy, breastfeeding or planning pregnancy in next 2 years

Plans to move out of the area in next 2 years

You had a heart problem in the last 6 months or have a condition that makes it hard to be active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive telephone-based motivational interviews to encourage increases in physical activity

24 months

Regular phone calls

Usual Care

Participants receive advice from their primary care physician and handouts about general health topics every 6 weeks

24 months

Handouts every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Telephone-based motivational interviews

Trial Overview The study tests if motivational interviews over the phone can help people with prediabetes or diabetes increase their physical activity. This could lead to better health outcomes and be used widely in primary care if successful.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.

Group II: Usual Care Active Control 1 Intervention

Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Findings from Research

In a study of 10,870 adults with diabetes, higher intensity and heterogeneity in lifestyle counseling documentation were linked to improved glycemic control, with patients in the highest tertile achieving HbA1c levels below 7.0% faster than those in the lowest tertile.

Specifically, an increase in documentation intensity by 45 characters per note and heterogeneity by 0.15 units significantly correlated with quicker time to reach target HbA1c levels, suggesting that detailed and varied counseling notes can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Documentation of Lifestyle Counseling and Glycemic Control in Patients With Diabetes. Hosomura, N., Goldberg, SI., Shubina, M., et al.[2022]

The Diabetes Conversation Map™ Program significantly improved clinical outcomes in participants with type 2 diabetes, showing lower HbA1c, glucose, and LDL levels, as well as increased frequency of glucose testing over a 36-month period compared to matched controls.

Participants also experienced better health behaviors, such as higher HDL and lower triglyceride levels at 6- and 12-month follow-ups, along with improved medication adherence and lower diastolic blood pressure at 6 months, indicating sustained benefits from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study. Srulovici, E., Leventer-Roberts, M., Curtis, B., et al.[2021]

A study involving 697 lower-income and minority patients demonstrated that high-quality health data can be reliably collected using self-administered questionnaires, even among those with literacy limitations, achieving over 84% item completion rates.

The research suggests that less expensive data collection methods, like mail-out/mail-back or hand-out/assisted questionnaires, can be effective, reducing the need for costly in-home interviews while still ensuring reliable data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of various methods of collecting self-reported health outcomes data among low-income and minority patients. Sullivan, LM., Dukes, KA., Harris, L., et al.[2019]

Notifying individuals of their prediabetes status led to significant improvements in fasting plasma glucose and weight loss over 18 months, suggesting that awareness can motivate lifestyle changes.

Participants with prediabetes reported better dietary and exercise habits compared to a control group, indicating that self-directed lifestyle modifications may be a key factor in improving glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. Owei, I., Umekwe, N., Ceesay, F., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

How patients with type 2 diabetes mellitus respond to motivational interviewing. [2022]

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

Electronic Documentation of Lifestyle Counseling and Glycemic Control in Patients With Diabetes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial. [2022]

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

Intervention Fidelity Focusing on Interaction between Participants and Facilitators in a Telephone-Delivered Health Coaching Intervention for the Prevention and Management of Type 2 Diabetes. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Motivational interviewing delivered by diabetes educators: does it improve blood glucose control among poorly controlled type 2 diabetes patients? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study. [2021]

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

A comparison of various methods of collecting self-reported health outcomes data among low-income and minority patients. [2019]

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

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility of the FINDRISC questionnaire to identify individuals with impaired glucose tolerance in Swedish primary care. A cross-sectional population-based study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Fitness consultations in routine care of patients with type 2 diabetes in general practice: an 18-month non-randomised intervention study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Barriers to participation and lifestyle change among lower versus higher income participants in the National Diabetes Prevention Program: lifestyle coach perspectives. [2023]

13. Pakistan pubmed.ncbi.nlm.nih.gov

The effect of motivational interview persons with diabetes on self-management and metabolic variables. [2022]