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Behavioural Intervention

Goal Setting for Exercise Adherence in Midlife Adults

N/A

Recruiting

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI between 30 kg/m2 to 50 kg/m2

Aged 45 to 65 years

Must not have

Self-reported current diagnosis of major depression

History of stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-months, 9-months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to identify techniques to help midlife adults get more physical activity, reducing their risk of Alzheimer's and dementia.

Who is the study for?

This trial is for midlife adults aged 45-65 with a BMI of 30-50, engaging in minimal physical activity and owning a smartphone. They must weigh at least 110 pounds and not be on Alzheimer's meds, have high blood pressure without clearance, or planning pregnancy/moving from Phoenix soon.

What is being tested?

The study tests goal-setting techniques to increase physical activity among midlife adults. It aims to improve self-regulation behaviors to meet national guidelines and reduce the risk of Alzheimer's disease through regular exercise adherence.

What are the potential side effects?

Since this trial involves increasing physical activity levels, potential side effects may include muscle soreness, fatigue, joint pain or injury due to new exercise routines. However, these are typically mild and decrease over time as fitness improves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30 and 50.

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I am between 45 and 65 years old.

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I weigh at least 110 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with major depression.

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I have had a stroke in the past.

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I am currently on two or more antidepressants.

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I have been prescribed an Alzheimer's medication before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-months, 9-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-months, 9-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-months, 9-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

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

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

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

+2 more

Other study objectives

Adjudication for Mild Cognitive Impairment (MCI)

Change in BMI from baseline to 6- and 9-months

Change in blood pressure (mmHG) from baseline to 6- and 9-months

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Static weekly physical activity goal of 150 minutes/weekExperimental Treatment1 Intervention

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.

Group II: Self-selected weekly physical activity goalExperimental Treatment1 Intervention

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.

Group III: No stated weekly physical activity goal (comparison group)Experimental Treatment1 Intervention

Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve.

Group IV: Incremental weekly physical activity goal increaseExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity

2019

Completed Phase 3

~4760

0 / 7Eligibility criteria met