Health Wearables and College Student Health

NCT03253406 | Completed

• 1 other identifier: STUDY00000386
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot randomized trial is to determine (1) the effectiveness of the Polar M400, used in combination with a twice-weekly Facebook-delivered Social Cognitive Theory-based health intervention, in the promotion of more healthful physical activity and nutritious eating behaviors over 12 weeks in college students versus a comparison group; and (2) the validity and reliability of the Polar M400 in the assessment of free-living (i.e., non-laboratory based) physical activity (in this case, steps per day and daily durations of moderate and vigorous physical activity) and energy expenditure.

Conditions

Behavior Change; Physical Activity; Young Adults; Technology; Intervention

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Will be assessed via Actigraph Link accelerometers with daily moderate-to-vigorous physical activity, light physical activity, sedentary behavior, steps per day, and energy expenditure the outcomes of interest. The Actigraph accelerometer has been validated among adults (Kaminsky \& Ozemek, 2012). Participants will wear the accelerometer for seven days (ensuring the collection of physical activity data on at least two weekdays and one weekend day) as suggested for field-based accelerometer research (Trost, McIver, \& Pate, 2005), with the accelerometer appended to the same wrist as the Polar M400. Accelerometry measurements will take place at baseline, six weeks, and 12 weeks to examine changes over time in the aforementioned outcomes.

  "Change in Physical Activity from Baseline to 6 Weeks" and "Change in Physical Activity from Baseline to 12 Weeks"

Secondary Outcomes (11)

• Cardiovascular Fitness

  "Change in Cardiovascular Fitness from Baseline to 12 Weeks"

• Body Composition

  "Change in Body Composition from Baseline to 12 Weeks"

• Body Weight

  "Change in Weight from Baseline to 12 Weeks"

• Self-Efficacy

  "Change in Self-Efficacy from Baseline to 12 Weeks"

• Social Support

  "Change in Social Support from Baseline to 12 Weeks"

Study Arms (2)

Polar M400 + Facebook Group (PM400+FG)

EXPERIMENTAL

Will be provided a Polar M400 to track physical activity and energy expenditure while also being included in a Facebook group wherein Social Cognitive Theory-based physical activity and nutritious eating tips will be provided twice weekly for 12 weeks.

Behavioral: Polar M400 + Facebook Group (PM400+FG)

Facebook Only Group (FG)

ACTIVE COMPARATOR

Included exclusively in a separate, but content-identical, Facebook group for 12 weeks.

Behavioral: Facebook Only Group (FG)

Interventions

Polar M400 + Facebook Group (PM400+FG) BEHAVIORAL

Throughout the intervention period experimental group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page. Additionally, experimental group participants will be asked to track all physical activity with the Polar M400 smartwatch and use this information to set physical activity-related goals conducive to improved health.

Polar M400 + Facebook Group (PM400+FG)

Facebook Only Group (FG) BEHAVIORAL

Throughout the intervention period comparison group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page.

Facebook Only Group (FG)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Body mass index ≥ 18.5
• Is currently not engaging in physical activity levels above the Physical Activity Guidelines for Americans (PAGA; U.S. Department of Health and Human Services, 2008)-verified through a structured screening interview prior to participant recruitment and randomization
• Eats less than the recommended two serving of fruits and three serving of vegetables per day (USDA, 2015)-verified through screening using a 10-item fruit and vegetable food frequency questionnaire (F. Thompson et al., 2002)
• No self-reported diagnosed physical/mental disability
• Provides informed consent and completes the Physical Activity Readiness Questionnaire (PAR-Q)
• Willing to be randomized into an intervention or comparison group

You may not qualify if:

• Self-reported diagnosed physical/mental disability
• Contraindication to physical activity participation as determined by PAR-Q results

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Physical Activity Epidemiology Laboratory

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Zan Gao, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Every attempt will be made to ensure participants do not know the group with which they have been randomized, accomplished by advertising to potential college student participants that two novel, technology-based interventions will be employed in the study, with no more detail provided. After screening and randomization, participants will be informed of study intervention procedures in an identical manner regardless of group allocation via the use of a study script repeated to each participant by the study's primary investigator. The only difference between the scripts will be a discussion with experimental group participants regarding how to use the Polar M400 smartwatch during the study intervention period. Importantly, college students will be brought into the Lab for screening and baseline testing on an individual basis ensuring the individuals from different groups have no idea of the differing intervention procedures utilized between the experimental and comparison groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm randomized pilot trial design will be used, with one Experimental Group and one Comparison Group. A random numbers table will be used to randomize participants with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: September 6, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 7, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)