AgingNCT03253341
Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
A study testing Smart Aging Program and Educational Materials in people with Aging and Health Behavior, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of delivering an exercise and healthy lifestyle program, Smart Aging, to older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Health Behavior
- What is being tested?
- Smart Aging Program and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Clinician referred
- Ambulatory: walk unassisted and successfully complete the 6 minute walk test without rest
- Sufficiently fluent in English to participate in study procedures
- Sedentary or underactive by the Telephone Assessment of Physical Activity61
Who cannot join
- Clinically-significant systemic or psychiatric illness that may affect safety or completion
- Diagnosis of dementia; use of dementia medications (cholinesterase inhibitors, memantine)
- Myocardial infarction or unstable coronary artery disease (e.g., angina, arrhythmia) in last 6 months.
- Cerebrovascular event (stroke or transient ischemic attack) in the last 6 months
- Cancer diagnosis in the last 2 years (except non-metastatic basal or squamous cell carcinoma or cancer in remission in the absence of treatment for at least 2 years)
- Significant pain or musculoskeletal disorder limiting the ability to participate safely
- Another member of the household enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to test the efficacy of delivering an exercise and healthy lifestyle program, Smart Aging, to older adults.
Read the detailed description
The Smart Aging Program is designed to be scalable, implementable, and sustainable in the real world. This program joins patients and their clinicians with community-based fitness centers. The Smart Aging Program looks to use already existing resources to deliver an innovative program to increase physical activity in older adults.
The program begins at the patient-physician level. The program is conducted in community-based fitness centers, the participant's home (home exercise, monitoring) and also sends physical activity data back to the clinician using mobile technology.
The Smart Aging Program consists of a personalized and structured exercise program combined with lifestyle education and mobile-health monitoring. The exercise program includes a 12-week initiation phase, followed by a 40-week maintenance phase.
- Conditions
- Aging, Health Behavior
- Being tested
- Smart Aging Program, Educational Materials
- Keywords
- exercise program, lifestyle changes, fitness program, lifestyle intervention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Aging ProgramBehavioural
Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.
Educational MaterialsBehavioural
Current standard of care. Includes education materials covering benefits of a healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Smart Aging Program | Experimental | Participants will be enrolled into the Smart Aging Program. Receives: Behavioral: Smart Aging Program |
| Control Group | Active comparator | Participants will be enrolled into group that receives educational materials that reflect the current standard of care. Receives: Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness
Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
Measured: Change from Baseline to 12 Weeks
Change in Cardiorespiratory Fitness
Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
Measured: Change from Baseline to 52 Weeks
Secondary outcomes (4)
Changes in Insulin Resistance
Measured using Homeostasis Model Assessment 2.
Measured: 52 Weeks
Change in Fat Mass
Measured using a dual energy x-ray absorptiometry (DEXA) scan.
Measured: 52 Weeks
Change in Lean Mass
Measured using a dual energy x-ray absorptiometry (DEXA) scan.
Measured: 52 Weeks
Change in Cholesterol
Changes in total cholesterol, LDL, and HDL will be measured.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Jul 2018
- Primary completion1 Jun 2021
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Burns, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253341
- Sponsor's protocol ID
- Smart Aging Program
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2017
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holden R, Szabo-Reed AN, Watts A, Clutton J, Finley K, Wolff SF, Burns JM. Physician referral is associated with recruitment, motivation, and adherence in an exercise intervention study for older adults. J Natl Med Assoc. 2026 Feb;118(1):103-112. doi: 10.1016/j.jnma.2025.11.002. Epub 2025 Nov 15.
PubMed 41298205Watts A, Szabo-Reed A, Baker J, Morris JK, Vacek J, Clutton J, Mahnken J, Key MN, Vidoni ED, Burns JM. LEAP! Rx: A randomized trial of a pragmatic approach to lifestyle medicine. Alzheimers Dement. 2024 Dec;20(12):8374-8386. doi: 10.1002/alz.14265. Epub 2024 Oct 8.
PubMed 39376152
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT03253341
- Acronym / sponsor ID
- Smart Aging Program
- Conditions
- Aging, Health Behavior
- Keywords
- exercise program, lifestyle changes, fitness program, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 17 Aug 2017 (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 purpose of this study is to test the efficacy of delivering an exercise and healthy lifestyle program, Smart Aging, to older adults.
Detailed description
The Smart Aging Program is designed to be scalable, implementable, and sustainable in the real world. This program joins patients and their clinicians with community-based fitness centers. The Smart Aging Program looks to use already existing resources to deliver an innovative program to increase physical activity in older adults.
The program begins at the patient-physician level. The program is conducted in community-based fitness centers, the participant's home (home exercise, monitoring) and also sends physical activity data back to the clinician using mobile technology.
The Smart Aging Program consists of a personalized and structured exercise program combined with lifestyle education and mobile-health monitoring. The exercise program includes a 12-week initiation phase, followed by a 40-week maintenance phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Aging Program | Experimental | Behavioral: Smart Aging ProgramParticipants will be enrolled into the Smart Aging Program. |
| Control Group | Active comparator | Behavioral: Educational MaterialsParticipants will be enrolled into group that receives educational materials that reflect the current standard of care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Clinician referred
- Ambulatory: walk unassisted and successfully complete the 6 minute walk test without rest
- Sufficiently fluent in English to participate in study procedures
- Sedentary or underactive by the Telephone Assessment of Physical Activity61
Key exclusion criteria (7 listed)
- Clinically-significant systemic or psychiatric illness that may affect safety or completion
- Diagnosis of dementia; use of dementia medications (cholinesterase inhibitors, memantine)
- Myocardial infarction or unstable coronary artery disease (e.g., angina, arrhythmia) in last 6 months.
- Cerebrovascular event (stroke or transient ischemic attack) in the last 6 months
- Cancer diagnosis in the last 2 years (except non-metastatic basal or squamous cell carcinoma or cancer in remission in the absence of treatment for at least 2 years)
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 |
|---|---|---|
| Smart Aging ProgramComprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities. | Behavioural | Smart Aging Program |
| Educational MaterialsCurrent standard of care. Includes education materials covering benefits of a healthy lifestyle. | Behavioural | Control Group |
Primary outcome
Change in Cardiorespiratory Fitness
Time frame: Change from Baseline to 12 Weeks
Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
Change in Cardiorespiratory Fitness
Time frame: Change from Baseline to 52 Weeks
Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
4 secondary outcomes
Changes in Insulin Resistance
Time frame: 52 Weeks
Change in Fat Mass
Time frame: 52 Weeks
Change in Lean Mass
Time frame: 52 Weeks
Change in Cholesterol
Time frame: 52 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 41298205Holden R, Szabo-Reed AN, Watts A, Clutton J, Finley K, Wolff SF, Burns JM. Physician referral is associated with recruitment, motivation, and adherence in an exercise intervention study for older adults. J Natl Med Assoc. 2026 Feb;118(1):103-112. doi: 10.1016/j.jnma.2025.11.002. Epub 2025 Nov 15.
- Derived from this study: PubMed 39376152Watts A, Szabo-Reed A, Baker J, Morris JK, Vacek J, Clutton J, Mahnken J, Key MN, Vidoni ED, Burns JM. LEAP! Rx: A randomized trial of a pragmatic approach to lifestyle medicine. Alzheimers Dement. 2024 Dec;20(12):8374-8386. doi: 10.1002/alz.14265. Epub 2024 Oct 8.
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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. This study is not recruiting at the moment.
Jeffrey Burns, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Aging Program and Educational Materials in people with Aging and Health Behavior, run by University of Kansas Medical Center at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory Fitness (time frame: Change from Baseline to 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253341, which also lists 2 linked publications.
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 14 Sep 2023.