Physical ActivityNCT05980052
Goal Setting to Promote Physical Activity Adherence in Midlife Adults
A study testing Physical Activity in people with Physical Activity and Exercise, run by Arizona State University at 1 site in United States.
Trial summary
Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Exercise
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 31 May 2027
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 45 to 65 years
- BMI between 30 kg/m2 to 50 kg/m2
- Participants must weigh a minimum of 110 pounds
- Engaging in 60 minutes or less of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
- Self-reported ownership of a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a Fitbit activity monitor)
Who cannot join
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
- Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
- Pregnant or planning to become pregnant in next 8-months (Phase 1) or 12 months (Phase 2)
- Plans to relocate out of metropolitan Phoenix, Arizona area in the next 8-months (Phase 1) or 12 months (Phase 2)
- Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
- Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Montreal Cognitive Assessment (MoCA) at the study orientation session. A score < 26 is an exclusion criterion for US born participants. A score of <23 is an exclusion for participants born outside of the US who completed their high school education in a country where English is not the primary language.
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- Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
- Score of 16 or higher on the Center for Epidemiological Studies-Depression Scale (CES-D)
- Self-reported current diagnosis of major depression
- Currently taking 2 or more ant-depression drugs
- History of stroke
- Incarcerated individuals (i.e., Prisoners)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Rodney P Joseph, 602-496-0772, rodney.joseph@asu.edu
Rodney P Joseph, PhD
About this study
Official title: Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-Of-Concept Trial
Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. The purpose of this mechanistic trial is to identify effective goal setting techniques to enhance psychosocial processes of self-regulation for the successful promotion of PA and adherence to national PA guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk
Read the detailed description
More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA), particularly in midlife, is associated with reduced risk for AD/ADRD. Yet, nearly half of midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA include self-regulation and self-efficacy. However, the most effective goal setting technique to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to national PA guidelines remains unclear. In the proposed study, the investigators will use a two-phased approach to empirically test three goal setting techniques to enhance psychosocial mechanisms of self-regulation and self-efficacy for the successful promotion of PA and adherence to national PA guidelines among insufficiently active midlife adults with obesity. In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial (6-month active intervention and 3-month no contact follow-up) will be implemented to establish preliminary efficacy of goal setting techniques to increase PA and promote adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor PA and engage in PA action planning sessions with a study interventionist. In addition, participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150 minutes/week of moderate-intensity PA, which most closely resembles the approach of public health campaigns and care providers; ii) weekly self-selected PA goals, which allows for self-determination and adaptation of the goal; iii) modest incremental weekly PA increase goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting Theory, it is hypothesized that participants in the incremental goal group will have the greatest increases in self-regulation and self-efficacy, which in turn, will lead to the greatest improvements in PA and adherence to national PA guidelines over the 9-month intervention.
- Conditions
- Physical Activity, Exercise
- Being tested
- Physical Activity
- Keywords
- exercise, physical activity, mild cognitive impairment, Alzheimer's disease, dementia, behavior change, midlife
- Medical subject headings
- Motor Activity, Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Theory-driven behavioral physical activity promotion intervention.
| Study group | Role | What they receive |
|---|---|---|
| Static weekly physical activity goal of 150 minutes/week | Experimental | Participants will receive a physical activity action planning intervention and assigned a static weekly physical activity goal of 150 minutes/week of moderate-intensity activity; action planning sessions will focus on the participant achieving this weekly goal. Receives: Behavioral: Physical Activity |
| Incremental weekly physical activity goal increase | Experimental | Participants will receive a physical activity action planning intervention and assigned a weekly physical activity goal that is 20% greater than the level of moderate-intensity physical activity performed the previous week; action planning sessions will focus on the participant achieving their assigned goal. Receives: Behavioral: Physical Activity |
| Self-selected weekly physical activity goal | Experimental | Participants will receive a physical activity action planning intervention and will self-select their own moderate-intensity physical activity goal each week; action planning sessions will focus on helping participants achieve their self-selected goal. Receives: Behavioral: Physical Activity |
| No stated weekly physical activity goal (comparison group) | Experimental | Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity.
Measured: Assessed at baseline, 6-months, 9-months
Change in Fitbit-assessed moderate-to-vigorous intensity physical activity
Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.
Measured: Assessed daily up to 9-months
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.
Measured: Assessed at baseline, 6-months, 9-months
Secondary outcomes (5)
Change in physical activity self-regulation from baseline to 6- and 9-months
Assessed using the The 12-item Physical Activity Self-Regulation Scale (PASR-12; Umstattd et al., 2009). This scale assess 6 PA-related self-regulatory domains: self-monitoring, goal setting, eliciting social support, reinforcements, time management, relapse prevention. The range of possible scores is 5-60, with higher scores indicating higher levels of physical activity self-regulation.
Measured: Assessed monthly up to 9-months
Change in physical activity behavioral strategies from baseline to 6- and 9-months
Assessed using 10-item Self-Regulation scale from the Health Belief Survey (Anderson et al., 2010) This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.
Measured: Assessed monthly up to 9-months
Change in physical activity self-efficacy from baseline to 6- and 9-months
Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.
Measured: Assessed monthly up to 9-months
Change in general self-regulation from baseline to 6- and 9-months
Assessed using the 31-item short version of the self-regulation scale (SSRS; Carey, Neal, \& Collins, 2004). The range of possible scores is 31 to 155, with higher scores indicate greater self-regulation
Measured: Assessed monthly up to 9-months
Change in General Self-Efficacy from baseline to 6- and 9-months
Assessed using the 10-item Self-Efficacy Scale publicly available in SOBC repository \& NIH Toolbox. The range of possible scores is 31 to 155. Higher scores indicate greater self-efficacy.
Measured: Assessed monthly up to 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start17 Jul 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Model description
- Four arm randomized mechanistic proof-of-concept trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980052
- Sponsor's protocol ID
- STUDY00016394
- Other IDs
- R61AG078089
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Joseph RP, Pituch KA, Yu F, Salisbury DL, Maxfield M. Comparing 3 Goal-Setting Techniques to Promote Adherence to National Physical Activity Guidelines in Midlife Adults: Feasibility Trial of a Mechanistic Study Design. JMIR Form Res. 2026 Mar 16;10:e82494. doi: 10.2196/82494.
PubMed 41838897
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-Of-Concept Trial
- ClinicalTrials.gov ID
- NCT05980052
- Acronym / sponsor ID
- STUDY00016394
- Conditions
- Physical Activity, Exercise
- Keywords
- exercise, physical activity, mild cognitive impairment, Alzheimer's disease, dementia, behavior change, midlife
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Aug 2023 (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.
Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. The purpose of this mechanistic trial is to identify effective goal setting techniques to enhance psychosocial processes of self-regulation for the successful promotion of PA and adherence to national PA guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk
Detailed description
More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA), particularly in midlife, is associated with reduced risk for AD/ADRD. Yet, nearly half of midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA include self-regulation and self-efficacy. However, the most effective goal setting technique to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to national PA guidelines remains unclear. In the proposed study, the investigators will use a two-phased approach to empirically test three goal setting techniques to enhance psychosocial mechanisms of self-regulation and self-efficacy for the successful promotion of PA and adherence to national PA guidelines among insufficiently active midlife adults with obesity. In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial (6-month active intervention and 3-month no contact follow-up) will be implemented to establish preliminary efficacy of goal setting techniques to increase PA and promote adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor PA and engage in PA action planning sessions with a study interventionist. In addition, participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150 minutes/week of moderate-intensity PA, which most closely resembles the approach of public health campaigns and care providers; ii) weekly self-selected PA goals, which allows for self-determination and adaptation of the goal; iii) modest incremental weekly PA increase goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting Theory, it is hypothesized that participants in the incremental goal group will have the greatest increases in self-regulation and self-efficacy, which in turn, will lead to the greatest improvements in PA and adherence to national PA guidelines over the 9-month intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four arm randomized mechanistic proof-of-concept trial
| Arm | Type | Receives |
|---|---|---|
| Static weekly physical activity goal of 150 minutes/week | Experimental | Behavioral: Physical ActivityParticipants will receive a physical activity action planning intervention and assigned a static weekly physical activity goal of 150 minutes/week of moderate-intensity activity; action planning sessions will focus on the participant achieving this weekly goal. |
| Incremental weekly physical activity goal increase | Experimental | Behavioral: Physical ActivityParticipants will receive a physical activity action planning intervention and assigned a weekly physical activity goal that is 20% greater than the level of moderate-intensity physical activity performed the previous week; action planning sessions will focus on the participant achieving their assigned goal. |
| Self-selected weekly physical activity goal | Experimental | Behavioral: Physical ActivityParticipants will receive a physical activity action planning intervention and will self-select their own moderate-intensity physical activity goal each week; action planning sessions will focus on helping participants achieve their self-selected goal. |
| No stated weekly physical activity goal (comparison group) | Experimental | Behavioral: Physical ActivityParticipants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 45 to 65 years
- BMI between 30 kg/m2 to 50 kg/m2
- Participants must weigh a minimum of 110 pounds
- Engaging in 60 minutes or less of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
- Self-reported ownership of a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a Fitbit activity monitor)
Key exclusion criteria (12 listed)
- Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
- Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
- Pregnant or planning to become pregnant in next 8-months (Phase 1) or 12 months (Phase 2)
- Plans to relocate out of metropolitan Phoenix, Arizona area in the next 8-months (Phase 1) or 12 months (Phase 2)
- Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
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 |
|---|---|---|
| Physical ActivityTheory-driven behavioral physical activity promotion intervention. | Behavioural | Incremental weekly physical activity goal increase, No stated weekly physical activity goal (comparison group), Self-selected weekly physical activity goal, Static weekly physical activity goal of 150 minutes/week |
Primary outcome
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Time frame: Assessed at baseline, 6-months, 9-months
Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity.
Change in Fitbit-assessed moderate-to-vigorous intensity physical activity
Time frame: Assessed daily up to 9-months
Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Time frame: Assessed at baseline, 6-months, 9-months
Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.
5 secondary outcomes
Change in physical activity self-regulation from baseline to 6- and 9-months
Time frame: Assessed monthly up to 9-months
Change in physical activity behavioral strategies from baseline to 6- and 9-months
Time frame: Assessed monthly up to 9-months
Change in physical activity self-efficacy from baseline to 6- and 9-months
Time frame: Assessed monthly up to 9-months
Change in general self-regulation from baseline to 6- and 9-months
Time frame: Assessed monthly up to 9-months
Change in General Self-Efficacy from baseline to 6- and 9-months
Time frame: Assessed monthly up to 9-months
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 17 Jul 2026.
- Derived from this study: PubMed 41838897Joseph RP, Pituch KA, Yu F, Salisbury DL, Maxfield M. Comparing 3 Goal-Setting Techniques to Promote Adherence to National Physical Activity Guidelines in Midlife Adults: Feasibility Trial of a Mechanistic Study Design. JMIR Form Res. 2026 Mar 16;10:e82494. doi: 10.2196/82494.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Physical Activity and Exercise, run by Arizona 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 5 inclusion and 12 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 17 Jul 2026. 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?
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 Rodney Joseph, PhD (602-496-0772, rodney.joseph@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months (time frame: Assessed at baseline, 6-months, 9-months). The study lists 3 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 NCT05980052, which also lists 1 linked publication.
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 17 Jul 2026.