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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-months, 9-months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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
~4710

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,370 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,741 Total Patients Enrolled

Media Library

Goal Setting (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05980052 — N/A
Physical Activity Research Study Groups: Incremental weekly physical activity goal increase, Self-selected weekly physical activity goal, No stated weekly physical activity goal (comparison group), Static weekly physical activity goal of 150 minutes/week
Physical Activity Clinical Trial 2023: Goal Setting Highlights & Side Effects. Trial Name: NCT05980052 — N/A
Goal Setting (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05980052 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial extend to participants under the age of twenty?

"This clinical trial has designated a target age group of 45–65 years old. There are 52 trials available for those below the minimum age and 125 studies that cater to individuals above 65 years old."

Answered by AI

What is the capacity for participants in this investigation?

"Correct. According to the data available on clinicaltrials.gov, this medical study is actively seeking volunteers to participate in its research, first posted on July 17th 2023 and last updated August 3rd of the same year. It requires 144 participants from a single site."

Answered by AI

Who has access to the enrollment criteria for this trial?

"To be eligible for this medical research, patients must exhibit a certain level of physical activity and have attained the age between 45 and 65 years old. Approximately 144 participants are being sought out."

Answered by AI

Is there still an opportunity for participants to join this trial?

"Affirmative. According to information on the clinicaltrials.gov website, this trial was first posted on July 17th 2023 and is still actively recruiting patients as of August 3rd 2023. A total of 144 participants need to be recruited from 1 medical centre for the study's completion."

Answered by AI

What are the projected benefits of this research endeavor?

"This clinical trial, which will be evaluated at baseline, 6-months and 9 months is intended to measure the alteration of moderate-to-vigorous intensity physical activity as recorded by Fitbit. As secondary objectives it also seeks to study any changes in behaviour strategies for incorporating physical activities (as measured with a Health Belief Survey) self efficacy (measured through an Exercise Self Efficacy survey), and general self regulation (via the 31 item short version of the self regulation scale). The scores on all these measures range from 1 to 5 or 31 to 155 respectively, with higher numbers indicating better results."

Answered by AI
~96 spots leftby Jan 2027