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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether motivational interviews over the phone can help people with diabetes or prediabetes become more active. Increased activity can lower the risks associated with these conditions. Participants will either receive motivational calls or continue with their usual care, which might include advice from their doctor and health handouts. This study suits those who have diabetes or prediabetes, are not very active, and have been members of Kaiser Permanente for at least a year. As an unphased trial, it offers a unique opportunity to contribute to research that could improve health outcomes for people with diabetes or prediabetes.

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 prior data suggests that telephone-based motivational interviews are safe for increasing physical activity in individuals with diabetes or prediabetes?

Research has shown that phone conversations designed to motivate people are generally safe. These talks aim to encourage more physical activity. As this method doesn't involve drugs or physical treatments, no known physical side effects exist. Studies have found that these conversations can help people with diabetes or prediabetes become more active. Being a non-invasive approach, it carries very low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using telephone-based motivational interviews to tackle sedentary lifestyles in individuals with diabetes and prediabetes. Unlike standard care, which often includes general advice and informational handouts, this approach involves personalized and direct interactions with trained professionals. This method taps into the power of motivation and personal encouragement, aiming to inspire lasting behavioral changes that increase physical activity. By offering tailored support over the phone, this approach could prove more accessible and effective, potentially leading to better health outcomes for those managing diabetes and prediabetes.

What evidence suggests that telephone-based motivational interviews are effective for increasing physical activity in diabetes and prediabetes?

Research has shown that talking with a counselor over the phone can help people with type 2 diabetes better control their blood sugar. In this trial, participants in the intervention arm will receive telephone-based motivational interviews to encourage more physical activity. Studies also suggest that this method can increase physical activity and boost confidence in managing diabetes. It may also help control blood pressure and improve overall diabetes care. Specifically, in older adults, phone conversations with a counselor increased physical activity. These findings suggest that this approach could help people with diabetes or prediabetes make healthier lifestyle changes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Receives primary care at the Fontana Medical Center

Kaiser Permanente member for at least 12 months

Your body mass index is between 18.5 and 40, which is a measure of your weight in relation to your height.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6332699/

Telephone-based motivational interviewing versus usual ... Intense lifestyle interventions, including physical activity and weight loss, can reduce the transition of prediabetes to diabetes [4]. However, ...

2. withpower.com withpower.com/trial/phase-prediabetic-state-7-2020-d85bd

Motivational Interviews for Sedentary Lifestyle in Diabetes ... Research shows that motivational interviewing, a technique used in telephone-based interventions, can help improve blood sugar control in people with type 2 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8912910/

Telehealth Delivery of Motivational Interviewing for Diabetes ... Conclusions. MI-based telehealth seems most effective for improving A1C, systolic blood pressure, diabetes self-efficacy, and physical activity behaviors.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748916000869

Effects of telephone-based motivational interviewing in ... It is also reported that telephone-based motivational interviewing has beneficial effects on self-efficacy for physical activity in persons over age 55 ( ...

5. researchgate.net researchgate.net/publication/258522864_Telephone-Based_Motivational_Interviewing_to_Promote_Physical_Activity_and_Stage_of_Change_Progression_in_Older_Adults

Telephone-Based Motivational Interviewing to Promote ... This study examined the efficacy of motivational interviewing (MI) for increasing physical activity in aging adults.

6. journals.humankinetics.com journals.humankinetics.com/view/journals/japa/22/4/article-p527.xml

in Journal of Aging and Physical Activity This study examined the efficacy of motivational interviewing (MI) for increasing physical activity in aging adults. Eighty-six participants aged 55 years ...