HealthyLifetime Program for Improving Health Behaviors

Recruiting in Ann Arbor (>99 mi)

Overseen By Margaret Calarco, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: More than three conditions, Anxiety, Depression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled study is to learn if, in addition to nurses, community members can be trained as health coaches to deliver the HealthyLifetime (HL) program to people without complex chronic health conditions, an intervention that provides a short-term and effective health coaching intervention delivered through a virtual platform to improve health, resiliency, and independent self-care to participants who are without complex chronic conditions. The main question it aims to answer is: • Can Community Health Coaches achieve the same level of competency and outcome as Nurse Health Coaches in participants without complex chronic conditions?

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 to focus on health coaching rather than medication changes.

What data supports the effectiveness of the HealthyLifetime treatment?

Research shows that lifestyle medicine programs, which focus on healthy behavior changes like better nutrition and more exercise, can lead to improvements in nutrition knowledge, physical activity, and overall quality of life. These findings suggest that similar programs, like HealthyLifetime, could be effective in promoting healthier lifestyles. ^{1 2 3 4 5}

Is the HealthyLifetime Program safe for humans?

The available research on similar health programs, like HealtheSteps™ and others, suggests they are generally safe and well-received by participants, focusing on improving lifestyle habits such as diet and exercise without significant safety concerns. ^{6 7 8 9 10}

How is the HealthyLifetime treatment different from other treatments for improving health behaviors?

The HealthyLifetime treatment is unique because it is a personalized health coaching program delivered electronically, including face-to-face videoconferencing, which aims to prevent functional decline and minimize chronic conditions in older adults. This approach is distinct from other treatments as it focuses on early intervention in aging and uses technology to provide tailored support. ^{11 12 13 14 15}

Research Team

Kathleen Potempa, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals without complex chronic health conditions who are interested in improving their health, resiliency, and self-care. Participants will receive guidance from community members trained as health coaches.

Inclusion Criteria

I am [Age] years old, born on [DOB], live at [Address], and my contact number is [Phone Number]. I have health issues including [Health Problems].

A score of less than 4 on items related to anxiety and depressive symptoms

Have a computer, iPad (Tablet), or Smartphone with an Internet connection, email address, a working camera, and microphone

Exclusion Criteria

A score of more than 4 on items related to anxiety and depressive symptoms

I am under 30 years old.

I do not have Medicare or Medicaid insurance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Community members are trained as health coaches to deliver the HealthyLifetime program

4 weeks

Treatment

Participants receive health coaching through the HealthyLifetime program delivered by either community health workers or nurse coaches

8 weeks

Virtual sessions

Follow-up

Participants are monitored for changes in self-reported medical visits, satisfaction, and lifestyle habits

12 weeks

Treatment Details

Interventions

• HealthyLifetime

Trial Overview The study tests if community members can be as effective as nurses when trained to deliver the HealthyLifetime program through a virtual platform. It's a randomized controlled trial comparing outcomes of coaching by community members versus nurses.

Participant Groups

Group I: Health worker coach Experimental Treatment 1 Intervention

HealthyLifetime program is administered by a community health worker

Group II: Nurse Coach Active Control 1 Intervention

HealthyLifetime program is administered by an experienced nurse coach.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Michigan Department of Health and Human Services

Collaborator

Trials

13

Recruited

10,900+

Centers for Medicare and Medicaid Services

Collaborator

Trials

41

Recruited

31,230,000+

Findings from Research

A study involving 171 community residents with metabolic syndrome showed that a 5-month initiation health program significantly improved lifestyle and laboratory test results, with benefits sustained over a 2-year follow-up.

Both the initiation program and a subsequent 6-month enhancing program led to similar improvements, indicating that even the shorter program was effective in promoting healthier lifestyles among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention study to promote self-improvement of lifestyle in a Japanese community: a new health support program. Fukumoto, K., Wei, CN., Matsuo, H., et al.[2021]

A pilot plant-based lifestyle medicine program in a safety-net healthcare system led to significant improvements in patient-reported outcomes, including a 7.2% increase in nutrition knowledge and a 12.2% increase in participants reporting good or very good sleep quality after 6 months.

Participants also experienced a reduction in barriers to adopting a plant-based diet and increased physical activity, highlighting the effectiveness of lifestyle medicine interventions in promoting healthier behaviors among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. Massar, RE., McMacken, M., Kwok, L., et al.[2023]

HealtheSteps™ is a lifestyle prescription program that effectively engages participants at risk for chronic diseases through bi-monthly coaching sessions focused on physical activity and healthy eating, showing high acceptability among both coaches and participants.

Participants appreciated the program's accountability features but suggested enhancements like increased feedback from coaches and more resources on healthy eating, indicating areas for improvement without needing major changes to the program's structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of the HealtheSteps™ lifestyle prescription program. Blunt, W., Gill, DP., Riggin, B., et al.[2019]

The Healthy Lifetime (HL) health coaching program significantly improved health habits in participants aged 50 and older with chronic conditions after 8 weeks, and these improvements were maintained at 20 weeks, indicating its efficacy in promoting healthier lifestyles.

Participants in the HL group also showed improved self-care agency, particularly those with high blood pressure, although this improvement did not last beyond the initial 8 weeks, highlighting the need for ongoing support in managing chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a theory-driven model of health coaching for older adults: short-term and sustained outcomes. Potempa, K., Calarco, M., Flaherty-Robb, M., et al.[2023]

References

1. Japan pubmed.ncbi.nlm.nih.gov

An intervention study to promote self-improvement of lifestyle in a Japanese community: a new health support program. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. [2023]

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

Participants stories about long-term achievement 60-months after attending a Healthy Life Centre programme (the VEND-RISK study) - a qualitative study. [2023]

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

Wise Choices: Nutrition and Exercise for Older Adults: A Community-Based Health Promotion Intervention. [2019]

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

Practical Opportunities for Healthy Diet and Physical Activity: Relationship to Intentions, Behaviors, and Body Mass Index. [2019]

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

Process evaluation of the HealtheSteps™ lifestyle prescription program. [2019]

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

Family self-tailoring: Applying a systems approach to improving family healthy living behaviors. [2018]

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

Comparison of Veteran experiences of low-cost, home-based diet and exercise interventions. [2014]

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

The Healthy Worker Project: a work-site intervention for weight control and smoking cessation. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Surviving & Thriving; a healthy lifestyle app for new US firefighters: usability and pilot study protocol. [2023]

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

A randomized trial of a theory-driven model of health coaching for older adults: short-term and sustained outcomes. [2023]

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

Enhancing multiple domains of well-being by decreasing multiple health risk behaviors: a randomized clinical trial. [2016]

13. Switzerland pubmed.ncbi.nlm.nih.gov

HealthyLIFE, a Combined Lifestyle Intervention for Overweight and Obese Adults: A Descriptive Case Series Study. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Mitigating preventable chronic disease: Progress report of the Cleveland Clinic's Lifestyle 180 program. [2021]

15. Canada pubmed.ncbi.nlm.nih.gov

Electronic Health Lifestyle Coaching Among Diabetes Patients in a Real-Life Municipality Setting: Observational Study. [2020]