NCT02204176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

July 25, 2014

Results QC Date

January 21, 2019

Last Update Submit

April 9, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Total Physical Activity

    The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin \& Shephard, 1985) was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise (open-ended format). Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, \& Boullon, 1986). Higher scores on this scale indicates more exercise engagement. Also, participants were loaned a pedometer to obtain objective measures of exercise activity. The pedometers allow participants to enter their weight and height and measure steps taken throughout the day based on this information. The devices automatically reset at midnight and store the information for 30 days.

    2-3 months after initial intervention session

  • Total Physical Activity

    The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin \& Shephard, 1985) was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise (open-ended format). Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, \& Boullon, 1986). Higher scores indicate more exercise engagement. Also, participants were loaned a pedometer to obtain objective measures of exercise activity. The pedometers allow participants to enter their weight and height and measure steps taken throughout the day based on this information. The devices automatically reset at midnight and store the information for 30 days.

    6 months after initial intervention session

Secondary Outcomes (2)

  • Exercise Self-efficacy

    2-3 months after initial intervention session

  • Exercise Self-efficacy

    6 months after initial intervention session

Other Outcomes (2)

  • Industriousness Level

    2-3 months after initial intervention session

  • Industriousness Level

    6 months after initial intervention session

Study Arms (3)

Exercise info only

SHAM COMPARATOR

Participants in the "exercise information only" group will engage in a group discussion with the principal investigator to discuss 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 (USDHHS, 2008) as well as risks associated with exercise and how they can be reduced.

Other: Exercise infoDevice: pedometer

Exercise info + implementation intentions

EXPERIMENTAL

Participants in the "exercise information plus implementation intentions" group will engage in a group discussion with the principal investigator to discuss all of the components from the exercise information only approach, but with more emphasis on how to create implementation intentions. Discussions will revolve around possible barriers to exercise plans and how to overcome/address 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).

Other: Exercise infoOther: Implementation intentionsDevice: pedometer

Exercise info + implementation intentions + industriousness

EXPERIMENTAL

Participants in the "exercise information plus implementation intentions plus industriousness training" group will engage in a group discussion with the principal investigator to discuss all of the components from the second approach as well as include findings linking industriousness and exercise behavior. Participants will be directed to think about and generate solutions to how they can become more industrious and monitor their efforts despite the difficulties they may face and relate these solutions to help them engage in more exercise behavior.

Other: Exercise infoOther: Implementation intentionsOther: IndustriousnessDevice: pedometer

Interventions

Discussion: * benefits of exercise * types of exercise * exercise guidelines * components of an exercise session * how to reduce risk of injuries

Exercise info + implementation intentionsExercise info + implementation intentions + industriousnessExercise info only

Discussion of: * barriers to exercise and how to address/overcome barriers * how to create detailed exercise plans

Exercise info + implementation intentionsExercise info + implementation intentions + industriousness

Discussion of: * realistic monitoring of efforts related to exercise * reaching and pushing past thresholds for sustained effort for exercise

Exercise info + implementation intentions + industriousness
pedometerDEVICE
Exercise info + implementation intentionsExercise info + implementation intentions + industriousnessExercise info only

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (11)

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PMID: 12365955BACKGROUND
  • Eisenberger R. Learned industriousness. Psychol Rev. 1992 Apr;99(2):248-67. doi: 10.1037/0033-295x.99.2.248.

    PMID: 1594725BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • McAuley E & Rudolph D. Physical activity, aging, and psychological well-being. Journal of Aging and Physical Activity 3: 67-96, 1995.

    BACKGROUND
  • National Heart, Lung, and Blood Institute. (2012, July 13). How are overweight and obesity diagnosed? Retrieved from http://www.nhlbi.nih.gov/health/health-topics/topics/obe/diagnosis.html

    BACKGROUND
  • U.S. Department of Health and Human Services. 2008 physical activity guidelines for Americans. Washington DC: U.S. Department of Health and Human Services, 2008.

    BACKGROUND
  • Webb TL & Sheeran P. Identifying good opportunities to act: Implementation intentions and cue discrimination. European Journal of Social Psychology, 34: 407-419, 2004.

    BACKGROUND
  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PMID: 4053261BACKGROUND
  • Benosovich SV, Rossi JS, Norman GJ, & Nigg CR. Development of a multidimensional measure of exercise self-efficacy. Annals of Behavioral Medicine, 20: S190, 1998.

    BACKGROUND
  • Roberts BW, Bogg T, Walton KE, Chernyshenko OS, & Stark. A lexical investigation of the lower-order structure of conscientiousness. Journal of Research in Personality, 38: 164-178, 2004.

    BACKGROUND
  • Hill PL, Roberts BW. The role of adherence in the relationship between conscientiousness and perceived health. Health Psychol. 2011 Nov;30(6):797-804. doi: 10.1037/a0023860. Epub 2011 May 23.

    PMID: 21604876BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Phuong Vo
Organization
Wayne State University and Michigan State University

Study Officials

  • Phuong T Vo, BA

    Wayne State University

    PRINCIPAL INVESTIGATOR
  • Tim D Bogg, PhD

    Wayne State University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 30, 2014

Study Start

August 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 3, 2019

Results First Posted

May 3, 2019

Record last verified: 2019-04

Locations