RecruitingNot Applicable

Goal Setting to Promote Physical Activity Adherence in Midlife Adults

United States144 participantsStarted 2023-07-17

Plain-language 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. 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

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study focuses on goal-setting strategies to help midlife adults stick with physical activity — given my current health status, is this kind of behavioral intervention something you'd feel comfortable with me participating in alongside any treatment I'm already on?
2The trial tracks physical activity intensity using both a Fitbit and an accelerometer device over 9 months — are there any medical reasons, like heart conditions or joint issues, why I should be cautious about increasing my moderate-to-vigorous physical activity right now?
3Since this study is listed as 'Phase NA,' meaning it's a behavioral research study rather than a drug trial, what does that mean for my safety oversight, and how does the level of monitoring here compare to what I'd get in a standard clinical setting?
4The study measures activity changes at 6 and 9 months, which is a fairly long commitment — do you think my current schedule, energy levels, and health situation make this kind of sustained participation realistic for me?
5Are there standard exercise programs or physical therapy options you'd recommend I consider first, or do you think enrolling in a structured research study like this one might actually be a better fit for where I am right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

Timeframe: Assessed at baseline, 6-months, 9-months

Change in Fitbit-assessed moderate-to-vigorous intensity physical activity

Timeframe: Assessed daily up to 9-months

Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

Timeframe: Assessed at baseline, 6-months, 9-months

Trial details

NCT IDNCT05980052

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Rodney Joseph, PhD

602-496-0772 rodney.joseph@asu.edu

View on ClinicalTrials.gov More Physical Activity trials

Plain-language summary

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

Timeframe: Assessed at baseline, 6-months, 9-months

Change in Fitbit-assessed moderate-to-vigorous intensity physical activity

Timeframe: Assessed daily up to 9-months

Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

Timeframe: Assessed at baseline, 6-months, 9-months