Health BehaviorsNCT06616246
Training Community Members to be Coaches to Deliver the HealthyLifetime Program
A study testing HealthyLifetime in people with Health Behaviors and Functional Decline, run by University of Michigan at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Health Behaviors, Functional Decline, Chronic Disease
- What is being tested?
- HealthyLifetime
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 30 years of age, with no more than three, uncomplicated chronic conditions and want to learn to take better care of their health.
- Independent Living Index (ILI) greater than 35. ILI is derived by averaging the outcome measures scores.
- A score of less than 4 on items related to anxiety and depressive symptoms
- Have Medicare and/or Medicaid insurance.
- Be able to read, speak, and hear English - but may use glasses or hearing aids, if needed;
- Tell us their age, date of birth, address, and phone number, and explain their health problems;
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- Have a computer, iPad (Tablet), or Smartphone with an Internet connection, email address, a working camera, and microphone;
- Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room
- Are not currently participating in any other studies involving diet, weight management, exercise and/or coaching at the current time; and
- Reside in Michigan.
Who cannot join
- ● Are less than 30 years of age.
- Have more than three, uncomplicated chronic conditions.
- A score of more than 4 on items related to anxiety and depressive symptoms
- Do not have Medicare and/or Medicaid insurance.
- Do not reside in Michigan.
- Have a new acute health problem that requires seeing a doctor more than once a month for acute medical treatment.
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- Have been told their illness is not curable.
- Need help remembering their name, date of birth, or health problems.
- Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily.
- Are currently participating in any other studies involving diet, weight management, exercise and/or coaching at the current time; and
- Do not have, or cannot use, a computer, iPad, or another device with the Internet at home to use Zoom (e.g., internet streaming).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48104
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Margaret Calarco, PhD, 734-615-0085, mcalarco@med.umich.edu
Kathleen Potempa, PhD, 734-615-0085, potempa@umich.edu
About this study
Official title: Evaluating the Use of Community Members Trained as Health Coaches to Deliver the HealthyLifetimeTM Program
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?
Read the detailed description
The investigators will evaluate the use of trained community members [Health Coach, (HC)] in delivering the HealthyLifetime program to adults without complex chronic conditions. Our cumulative learnings about effective HL strategies, training, and outcomes assessments set the stage for the proposed use of trained community members as HL Health Coaches under the supervision of the nurse Clinical Services Manager. The Independent Living Index (ILI) measures 'risk' for loss of independence due to functional decline from complex chronic conditions and other factors. The investigators will use the ILI and other medical information to determine which participants can be appropriately delegated to non-clinical staff coaches, which the investigators define as participants without complex chronic conditions. Our training methods will be adapted for use with community members. Our health coaching competency assessment tools will be used to measure community members trained as Health Coaches and Nurse Health Coach' relative competency. The investigators will compare quantitative and qualitative outcomes between participants coached by HL Health Coaches (community members) vs. HL Nurse Health Coaches and any outcome differences due to demographic, social determinants, or other factors. Finally, the investigators intend to evaluate the program satisfaction and potential cost impact using our Medical Use Index as a proxy for cost savings.
- Conditions
- Health Behaviors, Functional Decline, Chronic Disease, Risk Factors
- Being tested
- HealthyLifetime
- Keywords
- health coach, health resiliency, independent self-care, community health workers, independent aging
- Medical subject headings
- Health Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyLifetimeBehavioural
HealthyLifetimeTM [HL] seeks to intervene early in the aging process when individuals have the best chance for longer-term benefits of changing their health behavior, staving off functional decline, and minimizing the onset or exacerbation of chronic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Coach | Active comparator | HealthyLifetime program is administered by an experienced nurse coach. Receives: Behavioral: HealthyLifetime |
| Health worker coach | Experimental | HealthyLifetime program is administered by a community health worker Receives: Behavioral: HealthyLifetime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participant Self- rated satisfaction with various aspects of their home and neighborhood.
Participants perception of their home and neighborhood on a scale of 1= Extremely Satisfied to 5 = Not at all satisfied
Measured: At 0, 8 and 20 weeks after study enrollment.
Satisfaction with Quality of Life
Questions are about how participant experiences their quality of life on a scale where "1" = "Do not agree at all" and "5" = "Agree completely",
Measured: At 0, 8 and 20 weeks after study enrollment.
Positive and negative Lifestyle Habits aggregate
Composite score of activities that participants engage in that affect health in a negative (lower score) or positive way (higher score) on a scale of 1 to 5. Smoking (yes or no), alcohol (number of drinks per week, 5= none, 5= more than eight), exercise (1 = none to 5= more than 3 hours/week), food choices (One serving or less a day to 5 or more servings a day of positive, e.g., vegetable, or negative food choice, e.g., sugary food), amount of sleep (1 = less than 4 to 5 = more than 7 hours)
Measured: At 0, 8 and 20 weeks after study enrollment.
Change in Goal attainment score
Health goals of participants (up to 3) confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)
Measured: At 0, 8 and 12 weeks after study enrollment.
Change in Self-efficacy in ability to continue essential life activities
Ability or confidence of the participant in doing certain activities on a scale of 1= Cannot do this myself/Not confident at all to 5 = Always able to do myself/Completely Confident. For the purposes of answering these questions, confidence is defined as the belief in the participant\'s chances of being able to do and/or complete an activity (e.g., hobbies and recreation, social visits, chores, errands, etc.) or task (e.g., hobbies and recreation, social visits, chores, errands, etc.) successfully however the participant defines it.
Measured: At 0, 8 and 20 weeks after study enrollment.
Secondary outcomes (2)
Change in Sustained higher values of primary measures at 3 months
Are effects of program noted at 8 weeks still present at 20 weeks.
Measured: 20 weeks after study enrollment
Change in Self-reported medical visits
Number of unplanned medical visits with doctor or primary medical provider in past 2 months (0 to 10), emergency room visits (0 to 10 ), overnight stay in hospital (0 to 10).
Measured: At 0, 8 and 20 weeks after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 May 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Kathleen Potempa, University of Michigan
- Investigators
- Kathleen Potempa, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616246
- Sponsor's protocol ID
- 24-PAF04327
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Community Members Trained as Health Coaches to Deliver the HealthyLifetimeTM Program
- ClinicalTrials.gov ID
- NCT06616246
- Acronym / sponsor ID
- 24-PAF04327
- Conditions
- Health Behaviors, Functional Decline, Chronic Disease, Risk Factors
- Keywords
- health coach, health resiliency, independent self-care, community health workers, independent aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Centers for Medicare and Medicaid Services
- Study start
- 15 May 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The investigators will evaluate the use of trained community members [Health Coach, (HC)] in delivering the HealthyLifetime program to adults without complex chronic conditions. Our cumulative learnings about effective HL strategies, training, and outcomes assessments set the stage for the proposed use of trained community members as HL Health Coaches under the supervision of the nurse Clinical Services Manager. The Independent Living Index (ILI) measures 'risk' for loss of independence due to functional decline from complex chronic conditions and other factors. The investigators will use the ILI and other medical information to determine which participants can be appropriately delegated to non-clinical staff coaches, which the investigators define as participants without complex chronic conditions. Our training methods will be adapted for use with community members. Our health coaching competency assessment tools will be used to measure community members trained as Health Coaches and Nurse Health Coach' relative competency. The investigators will compare quantitative and qualitative outcomes between participants coached by HL Health Coaches (community members) vs. HL Nurse Health Coaches and any outcome differences due to demographic, social determinants, or other factors. Finally, the investigators intend to evaluate the program satisfaction and potential cost impact using our Medical Use Index as a proxy for cost savings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Coach | Active comparator | Behavioral: HealthyLifetimeHealthyLifetime program is administered by an experienced nurse coach. |
| Health worker coach | Experimental | Behavioral: HealthyLifetimeHealthyLifetime program is administered by a community health worker |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 30 years of age, with no more than three, uncomplicated chronic conditions and want to learn to take better care of their health.
- Independent Living Index (ILI) greater than 35. ILI is derived by averaging the outcome measures scores.
- A score of less than 4 on items related to anxiety and depressive symptoms
- Have Medicare and/or Medicaid insurance.
- Be able to read, speak, and hear English - but may use glasses or hearing aids, if needed;
Key exclusion criteria (11 listed)
- ● Are less than 30 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyLifetimeHealthyLifetimeTM [HL] seeks to intervene early in the aging process when individuals have the best chance for longer-term benefits of changing their health behavior, staving off functional decline, and minimizing the onset or exacerbation of chronic conditions. | Behavioural | Health worker coach, Nurse Coach |
Primary outcome
Change in Participant Self- rated satisfaction with various aspects of their home and neighborhood.
Time frame: At 0, 8 and 20 weeks after study enrollment.
Participants perception of their home and neighborhood on a scale of 1= Extremely Satisfied to 5 = Not at all satisfied
Satisfaction with Quality of Life
Time frame: At 0, 8 and 20 weeks after study enrollment.
Questions are about how participant experiences their quality of life on a scale where "1" = "Do not agree at all" and "5" = "Agree completely",
Positive and negative Lifestyle Habits aggregate
Time frame: At 0, 8 and 20 weeks after study enrollment.
Composite score of activities that participants engage in that affect health in a negative (lower score) or positive way (higher score) on a scale of 1 to 5. Smoking (yes or no), alcohol (number of drinks per week, 5= none, 5= more than eight), exercise (1 = none to 5= more than 3 hours/week), food choices (One serving or less a day to 5 or more servings a day of positive, e.g., vegetable, or negative food choice, e.g., sugary food), amount of sleep (1 = less than 4 to 5 = more than 7 hours)
Change in Goal attainment score
Time frame: At 0, 8 and 12 weeks after study enrollment.
Health goals of participants (up to 3) confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)
Change in Self-efficacy in ability to continue essential life activities
Time frame: At 0, 8 and 20 weeks after study enrollment.
Ability or confidence of the participant in doing certain activities on a scale of 1= Cannot do this myself/Not confident at all to 5 = Always able to do myself/Completely Confident. For the purposes of answering these questions, confidence is defined as the belief in the participant\'s chances of being able to do and/or complete an activity (e.g., hobbies and recreation, social visits, chores, errands, etc.) or task (e.g., hobbies and recreation, social visits, chores, errands, etc.) successfully however the participant defines it.
2 secondary outcomes
Change in Sustained higher values of primary measures at 3 months
Time frame: 20 weeks after study enrollment
Change in Self-reported medical visits
Time frame: At 0, 8 and 20 weeks after study enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Potempa, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyLifetime in people with Health Behaviors and Functional Decline, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Potempa, PhD (734-615-0085, potempa@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Participant Self- rated satisfaction with various aspects of their home and neighborhood. (time frame: At 0, 8 and 20 weeks after study enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.