Goal Setting to Promote Physical Activity Adherence in Midlife Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorArizona State University

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical Activity

    Behavioral

    Theory-driven behavioral physical activity promotion intervention.

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: Static weekly physical activity goal of 150 minutes/weekExperimental treatment 1 intervention
Group B: Incremental weekly physical activity goal increaseExperimental treatment 1 intervention
Group C: Self-selected weekly physical activity goalExperimental treatment 1 intervention
Group D: No stated weekly physical activity goal (comparison group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at baseline, 6-months, 9-months
2

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.

Time frame
Assessed daily up to 9-months
3

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.

Time frame
Assessed at baseline, 6-months, 9-months

Secondary outcomes

1

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.

Time frame
Assessed monthly up to 9-months
2

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.

Time frame
Assessed monthly up to 9-months
3

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.

Time frame
Assessed monthly up to 9-months
4

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

Time frame
Assessed monthly up to 9-months

Other outcomes

1

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

Assessed using the Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.

Time frame
Assessed at baseline, 6-months, 9-months
2

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

Assessed using the Delayed Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.

Time frame
Assessed at baseline, 6-months, 9-months
3

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

Assessed using the Picture Sequence Memory Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.

Time frame
Assessed at baseline, 6-months, 9-months
4

Change in executive function from baseline to 6- and 9-months

Assessed using the Dimensional Change Card Sort Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.

Time frame
Assessed at baseline, 6-months, 9-months

Sponsors and contacts

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Arizona State University

Lead sponsor

National Institute on Aging (NIA)

Collaborator