Physical ActivityNCT03299348
AgingPLUS: Promoting Physical Activity in Adults
A study testing AgingPLUS in people with Physical Activity, run by Colorado State University at 1 site in United States.
Trial summary
This study examines the efficacy of a psycho-educational intervention program, AgingPLUS, with regard to increasing middle-aged and older adults' engagement in physical activity. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- AgingPLUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 May 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who engage in less than 60 minutes of PA per week and who intend starting a physical exercise program.
- English speaking.
- Willingness to be randomized to one of two programs.
- Willingness to take part in the physical fitness tests and wear an accelerometer.
- Willingness to commit to follow-up testing (i.e., not moving out of the area during the study period).
- Physician clearance to take part in a submaximal exercise test and to begin an exercise program.
Who cannot join
- Signs of cognitive decline (defined as more than 4 errors on the Short Portable Mental Status Questionnaire).
- Severe vision and/or hearing loss (obtained by self-report).
- Serious problems with mobility.
- A history of neurological, mental, or substance abuse disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1570
About this study
Official title: Testing Psychological Mechanisms to Promote Physical Activity in Adults
This study examines the efficacy of a psycho-educational intervention program, AgingPLUS, with regard to increasing middle-aged and older adults' engagement in physical activity.
Read the detailed description
AgingPLUS is a multi-component intervention program that addresses negative views of aging (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that keeps adults from engaging in health-promoting behavior. The program focuses on engagement in physical activity (PA) as the health behavior of choice. Engagement in PA is widely recognized as the best non-pharmacological, non-invasive, and cost-effective method of health promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This suggests that messages about the benefits of PA alone are not effective. Rather, it is essential to address the social-cognitive and motiva-tional mechanisms that prevent adults from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and deficient goal planning represent such a cluster of social-cognitive and motivational mechanisms.
Given this background, the specific aims and hypotheses of the proposed research are:
Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS program.
Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.
Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.
Upon completion of this project, we expect to have successfully established evidence for the efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to develop AgingPLUS into a full-fledged evidence-based program that can be implemented in community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective public health tool to promote healthy and successful aging.
- Conditions
- Physical Activity
- Being tested
- AgingPLUS, Active Control Group
- Keywords
- Psychological Mechanisms, Social-Cognitive Mechanisms
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgingPLUSBehavioural
The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans.
Active Control GroupBehavioural
The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | This group will get the AgingPLUS intervention program which addresses negative views on aging, low internal control beliefs, and deficient goal planning skills. Receives: Behavioral: AgingPLUS |
| Active Control Group | Placebo comparator | This group will get a generic health education program, called the "10 Keys to Healthy Aging". The control program will control for the effect of social contact and will not address the intervention targets of the active treatment group. The health education program will only provide information related to some of the most important health conditions, such as cardiovascular disease, cancer, type 2 diabetes, and clinical depression, and how these conditions can be managed. Receives: Behavioral: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased physical activity
We expect that participants significantly increase their engagement in physical activity as assessed by an accelerometer.
Measured: This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 May 2018
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has an active treatment group and an active control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Manfred Diehl, PhD, Colorado State University
- Investigators
- Manfred K. Diehl, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299348
- Sponsor's protocol ID
- 3437
- Other IDs
- 5R01AG051723-05
- Status last verified
- Jun 2025
- First submitted
- 23 Sep 2017
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brothers A, Diehl M. Feasibility and Efficacy of the AgingPlus Program: Changing Views on Aging to Increase Physical Activity. J Aging Phys Act. 2017 Jul;25(3):402-411. doi: 10.1123/japa.2016-0039. Epub 2016 Dec 5.
PubMed 27918687Diehl M, Nehrkorn-Bailey A, Thompson K, Rodriguez D, Li K, Rebok GW, Roth DL, Chung SE, Bland C, Feltner S, Forsyth G, Hulett N, Klein B, Mars P, Martinez K, Mast S, Monasterio R, Moore K, Schoenberg H, Thomson E, Tseng HY. The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults. Contemp Clin Trials. 2020 Sep;96:106105. doi: 10.1016/j.cct.2020.106105. Epub 2020 Aug 11.
PubMed 32791322Nehrkorn-Bailey AM, Rodriguez D, Forsyth G, Braun B, Burke K, Diehl M. Change in Views of Aging, Physical Activity, and Physical Health Over 8 Weeks: Results From a Randomized Study. J Aging Phys Act. 2023 Jan 28;31(4):666-678. doi: 10.1123/japa.2022-0133. Print 2023 Aug 1.
PubMed 36708712Diehl M, Tseng HY, Rebok GW, Li K, Nehrkorn-Bailey AM, Rodriguez D, Chen D, Roth DL. Testing the purported mechanisms of the AgingPLUS intervention: Effects on physical activity outcomes. Psychol Aging. 2025 Jun;40(4):355-370. doi: 10.1037/pag0000893. Epub 2025 Apr 10.
PubMed 40208719Tseng HY, Chasteen AL, Diehl M. Examining the malleability of implicit views of aging in middle-aged and older adults. Psychol Aging. 2025 Mar;40(2):147-158. doi: 10.1037/pag0000867. Epub 2024 Nov 25.
PubMed 39585776
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Psychological Mechanisms to Promote Physical Activity in Adults
- ClinicalTrials.gov ID
- NCT03299348
- Acronym / sponsor ID
- 3437
- Conditions
- Physical Activity
- Keywords
- Psychological Mechanisms, Social-Cognitive Mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Aging (NIA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 3 Oct 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.
This study examines the efficacy of a psycho-educational intervention program, AgingPLUS, with regard to increasing middle-aged and older adults' engagement in physical activity.
Detailed description
AgingPLUS is a multi-component intervention program that addresses negative views of aging (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that keeps adults from engaging in health-promoting behavior. The program focuses on engagement in physical activity (PA) as the health behavior of choice. Engagement in PA is widely recognized as the best non-pharmacological, non-invasive, and cost-effective method of health promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This suggests that messages about the benefits of PA alone are not effective. Rather, it is essential to address the social-cognitive and motiva-tional mechanisms that prevent adults from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and deficient goal planning represent such a cluster of social-cognitive and motivational mechanisms.
Given this background, the specific aims and hypotheses of the proposed research are:
Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS program.
Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.
Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.
Upon completion of this project, we expect to have successfully established evidence for the efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to develop AgingPLUS into a full-fledged evidence-based program that can be implemented in community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective public health tool to promote healthy and successful aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study has an active treatment group and an active control group
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Behavioral: AgingPLUSThis group will get the AgingPLUS intervention program which addresses negative views on aging, low internal control beliefs, and deficient goal planning skills. |
| Active Control Group | Placebo comparator | Behavioral: Active Control GroupThis group will get a generic health education program, called the "10 Keys to Healthy Aging". The control program will control for the effect of social contact and will not address the intervention targets of the active treatment group. The health education program will only provide information related to some of the most important health conditions, such as cardiovascular disease, cancer, type 2 diabetes, and clinical depression, and how these conditions can be managed. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults who engage in less than 60 minutes of PA per week and who intend starting a physical exercise program.
- English speaking.
- Willingness to be randomized to one of two programs.
- Willingness to take part in the physical fitness tests and wear an accelerometer.
- Willingness to commit to follow-up testing (i.e., not moving out of the area during the study period).
Key exclusion criteria (4 listed)
- Signs of cognitive decline (defined as more than 4 errors on the Short Portable Mental Status Questionnaire).
- Severe vision and/or hearing loss (obtained by self-report).
- Serious problems with mobility.
- A history of neurological, mental, or substance abuse disorders.
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 |
|---|---|---|
| AgingPLUSThe program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans. | Behavioural | Active Treatment Group |
| Active Control GroupThe program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully. | Behavioural | Active Control Group |
Primary outcome
Increased physical activity
Time frame: This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.
We expect that participants significantly increase their engagement in physical activity as assessed by an accelerometer.
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 19 Jun 2025.
- Background: PubMed 27918687Brothers A, Diehl M. Feasibility and Efficacy of the AgingPlus Program: Changing Views on Aging to Increase Physical Activity. J Aging Phys Act. 2017 Jul;25(3):402-411. doi: 10.1123/japa.2016-0039. Epub 2016 Dec 5.
- Background: PubMed 32791322Diehl M, Nehrkorn-Bailey A, Thompson K, Rodriguez D, Li K, Rebok GW, Roth DL, Chung SE, Bland C, Feltner S, Forsyth G, Hulett N, Klein B, Mars P, Martinez K, Mast S, Monasterio R, Moore K, Schoenberg H, Thomson E, Tseng HY. The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults. Contemp Clin Trials. 2020 Sep;96:106105. doi: 10.1016/j.cct.2020.106105. Epub 2020 Aug 11.
- Background: PubMed 36708712Nehrkorn-Bailey AM, Rodriguez D, Forsyth G, Braun B, Burke K, Diehl M. Change in Views of Aging, Physical Activity, and Physical Health Over 8 Weeks: Results From a Randomized Study. J Aging Phys Act. 2023 Jan 28;31(4):666-678. doi: 10.1123/japa.2022-0133. Print 2023 Aug 1.
- Derived from this study: PubMed 40208719Diehl M, Tseng HY, Rebok GW, Li K, Nehrkorn-Bailey AM, Rodriguez D, Chen D, Roth DL. Testing the purported mechanisms of the AgingPLUS intervention: Effects on physical activity outcomes. Psychol Aging. 2025 Jun;40(4):355-370. doi: 10.1037/pag0000893. Epub 2025 Apr 10.
- Derived from this study: PubMed 39585776Tseng HY, Chasteen AL, Diehl M. Examining the malleability of implicit views of aging in middle-aged and older adults. Psychol Aging. 2025 Mar;40(2):147-158. doi: 10.1037/pag0000867. Epub 2024 Nov 25.
- 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. This study is not recruiting at the moment.
Manfred K. Diehl, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AgingPLUS in people with Physical Activity, run by Colorado State University 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 6 inclusion and 4 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 19 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Increased physical activity (time frame: This effect should be observable (1) at the Week-4 post-test, (2) the Week-8 post-test, and (3) the 6-Month post-test.). 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 NCT03299348, which also lists 5 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 19 Jun 2025.