Clinical trial NCT05980052: Goal Setting to Promote Physical Activity Adherence in Midlife Adults
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Exercise
Keywords: exercise
physical activity
mild cognitive impairment
Alzheimer's disease
dementia
behavior change
midlife
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-07
Enrollment: 144
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four arm randomized mechanistic proof-of-concept trial
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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 where English is not the primary language.
* 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)

Primary outcomes:
measure: 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
measure: Change in Fitbit-assessed moderate-to-vigorous intensity physical activity
timeFrame: Assessed daily up to 9-months
measure: 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
Secondary outcomes:
measure: Change in physical activity self-regulation from baseline to 6- and 9-months
timeFrame: Assessed monthly up to 9-months
measure: Change in physical activity behavioral strategies from baseline to 6- and 9-months
timeFrame: Assessed monthly up to 9-months
measure: Change in physical activity self-efficacy from baseline to 6- and 9-months
timeFrame: Assessed monthly up to 9-months
measure: Change in general self-regulation from baseline to 6- and 9-months
timeFrame: Assessed monthly up to 9-months
measure: Change in General Self-Efficacy from baseline to 6- and 9-months
timeFrame: Assessed monthly up to 9-months
Other outcomes:
measure: Change in immediate verbal memory from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in delayed verbal memory from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in visual memory from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in executive function from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in pattern comparison processing speed from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in processing speed from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Adjudication for Mild Cognitive Impairment (MCI)
timeFrame: Performed using data collected at 6-months and 9-months
measure: Change in body weight from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in BMI from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in blood pressure (mmHG) from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months
timeFrame: baseline, 6-months, 9-months
measure: Change in serum lipids (mg/DL) from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Change in depressive symptoms from baseline to 6- and 9-months
timeFrame: Assessed at baseline, 6-months, 9-months
measure: Protocol Adherence
timeFrame: Assessed at 6-months and 9-months
measure: Treatment acceptance
timeFrame: Assessed at 6-months and 9-months
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: