Clinical trial NCT02204176: Exercise Behavior Among Young Adults Study
Official title: Exercise Behavior Among Young Adults Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The rate of adult obesity in the United States has increased more than two times since 1970, and the rate of child-teen obesity has increased by four times. One of the antecedents of obesity is an inactive lifestyle. Exercise has been known to be associated with increases in both physical and mental health by increasing longevity, preventing risk of obesity, coronary heart disease, and hypertension, and increasing self-esteem and overall quality of life. The broad aim of the current study is to investigate the effectiveness of psychoeducational training to increase exercise activity initiation and maintenance in young adults.

The goal of this study is to compare three training approaches for college students to increase exercise behavior. One approach provides general information on the different types of exercises and benefits of engaging in exercise behavior after an initial questionnaire assessment session. A second approach includes the general exercise information and questionnaire assessment as well as training on how to create specific goal intentions (i.e., implementation intentions) to aid in exercise initiation. A third approach uses all the components of the second approach but also tests the utility of a personality-informed module by incorporating concepts from the theory of learned industriousness. It is expected that the third approach will be the most effective in helping participants initiate and maintain their exercise activities during the course of the study duration.

Detailed description: The aims of the study (mentioned in the Brief Summary) will be addressed using a 6-month multi-wave assessment of approximately 200 college students. Participants will be randomly assigned to one of the three approaches once it is determined they meet study criteria. Random assignment will occur when the participants are scheduled for the first session.

All participants will partake in three group sessions. The first session will take approximately 2 hours to complete. The second and third sessions will be scheduled 2 and 6 months after the first session and will take approximately 45 minutes each to complete.

In the initial session for the first approach, the group session will include discussion of what constitutes regular physical activity and benefits of exercise and basic tips on the activity itself. Guidelines for prescribing suggested exercises will be based on recommendations from the U.S. Department of Health and Human Services as well as risks associated with exercise and how they can be reduced.

In the initial session for the second approach, the group session will include discussion of all the components from the first approach, but with more emphasis on how to create implementation intentions. Discussions will revolve around possible barriers to exercise plans and how to overcome those barriers by making specific plans of when and where to exercise, along with designating which types of exercises they will perform and for how long (or how many repetitions).

In the initial session for the third approach, the group session will include discussion of all the components from the second approach as well as include findings on industriousness. Participants will be directed to think about and generate solutions to how they can become more industrious despite the difficulties they may face and relate these solutions to help them engage in more exercise behavior.

For all approaches, participants will complete questionnaires regarding aspects of their personality, attitudes regarding exercise, beliefs about the positive and negative effects of exercise, confidence in engaging in exercise despite barriers, and current levels of exercise. Participants' body mass index will also be measured. All participants will be given an exercise booklet tailored to their respective approaches to record their exercise behavior during the three weeks following the initial session. They will also be loaned a pedometer that will be used to track their overall daily activities for the same three-week period. Participants in the third approach will also receive booster contacts (to encourage them to think about their efforts and monitoring of physical activity) every two weeks starting after the three-week tracking period until their six-month follow up (total of 11 booster contacts).

The first session will be video and audio recorded to check on and ensure presentation consistency. At the end of the first session, participants will be given a post-session survey to gauge how well materials were presented and to determine how much information participants felt they gained from the session. When participants return their daily exercise diaries and pedometers, they will also complete a condensed set of measures (similar to those in the first session) to track any changes experienced during the three-week tracking period.

For the 2- and 6-month follow-up sessions, participants in all approaches will complete the same questionnaires as in the initial session and have their body mass index measured.

Power analyses conducted via G\*Power, 3.1.6 indicated that 159 participants will be needed to detect an effect size of F of 0.25 with alpha error probability at 0.05 and power at 1-Β =.80. Oversampling by 25% will occur to account for possible attrition from the study, thereby making the target N = 200.

Eligibility criteria: Inclusion Criteria:

* be currently enrolled in full-time university coursework
* be between 18 and 24 years old
* understand and respond to screening questions in English
* be able to read at a Grade 6 level
* have adequate health, as assessed by having a body mass index between 18.5 and 29.9 (anyone with a BMI of 30+ is considered obese; National Heart, Lung, \& Blood Institute, 2012) to ensure that regular, moderate to intense exercise activity will not negatively affect health
* identify as individuals who have tried to initiate and continue an exercise regimen sometime in the past but have been unable to maintain the activity
* indicate the desire to initiate physical activity at the current time
* be willing to attempt to maintain an exercise schedule during the three-week intervention period to which they will be randomly assigned
* be willing to participate in the 2-month and 6-month follow up periods

Exclusion Criteria:

* not already be meeting current USDHHS physical activity recommendations (i.e., at least 150 minutes of moderate-intensity exercise per week)
* not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)
* not report consuming more than three (women) or four (men) alcoholic drinks per day (as this may interfere with their ability to engage in physical activity and confound study results)
* not be pregnant
* not have children
* not have preexisting physical limitations or recent injuries
* not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)

Primary outcomes:
measure: Total Physical Activity
timeFrame: 2-3 months after initial intervention session
measure: Total Physical Activity
timeFrame: 6 months after initial intervention session
Secondary outcomes:
measure: Exercise Self-efficacy
timeFrame: 2-3 months after initial intervention session
measure: Exercise Self-efficacy
timeFrame: 6 months after initial intervention session
Other outcomes:
measure: Industriousness Level
timeFrame: 2-3 months after initial intervention session
measure: Industriousness Level
timeFrame: 6 months after initial intervention session
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Phuong T Vo, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Tim D Bogg, PhD
role: STUDY_DIRECTOR
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