Goal Setting to Promote Physical Activity Adherence in Midlife Adults

NCT05980052 | Recruiting

• 2 other identifiers: STUDY00016394R61AG078089
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Physical Activity; Exercise

Keywords

exercise; physical activity; mild cognitive impairment; Alzheimer's disease; dementia; behavior change; midlife

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed at baseline, 6-months, 9-months

Secondary Outcomes (5)

• Change in physical activity self-regulation from baseline to 6- and 9-months

  Assessed monthly up to 9-months

• Change in physical activity behavioral strategies from baseline to 6- and 9-months

  Assessed monthly up to 9-months

• Change in physical activity self-efficacy from baseline to 6- and 9-months

  Assessed monthly up to 9-months

• Change in general self-regulation from baseline to 6- and 9-months

  Assessed monthly up to 9-months

• Change in General Self-Efficacy from baseline to 6- and 9-months

  Assessed monthly up to 9-months

Other Outcomes (18)

• Change in immediate verbal memory from baseline to 6- and 9-months

  Assessed at baseline, 6-months, 9-months

• Change in delayed verbal memory from baseline to 6- and 9-months

  Assessed at baseline, 6-months, 9-months

• Change in visual memory from baseline to 6- and 9-months

  Assessed at baseline, 6-months, 9-months

Study Arms (4)

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.

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.

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.

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.

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Theory-driven behavioral physical activity promotion intervention.

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rodney Joseph, PhD

CONTACT

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

Molly Maxfield, PhD

CONTACT

602-496-2311; molly.maxfield@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four arm randomized mechanistic proof-of-concept trial

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 7, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)