An interventional study of Polar M400 + Facebook Group (PM400+FG) and Facebook Only Group (FG) in Behavior Change, Physical Activity and Young Adults, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
Among 34 studies in Motor Activity by University of Minnesota — 1 open to participants now, 2 under way, none of them phase 3. Motor Activity · University of Minnesota.
Among the 34 studies in Motor Activity by University of Minnesota, this one is the 23rd largest by enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2017, is one of 29 with no phase, and was the 19th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →1 of the 34 studies in Motor Activity by University of Minnesota is open now, in 1 country. Recruiting first, the newest first:
University of Minnesota · Sites in United States
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years to 29 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 2
First in 2005; this study’s year is marked. 2 started in 2017.
This study's enrollment of 38 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 77 across the 33 interventional studies, 0 across the 1 observational. Of the 29 that completed or were terminated, 7 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
1 of the studies in Motor Activity by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07649135University of MinnesotaFeasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke | 2026-11-30 |
Among the 34 studies in Motor Activity by University of Minnesota, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
The prevalence of overweight and obesity among individuals 20-39 years of age is 60.9%. Unfortunately, physical inactivity and poor dietary practices among this age cohort appear to be two major contributory factors for the preceding statistic. Among the youngest individuals within this age cohort are college students. Research suggests college students possess risk factors for overweight and obesity as many of these individuals are now independent and, for some, making physical activity- and nutrition-related decisions autonomously for the first time. Studies on obesity- and weight-related behaviors in this population suggest approximately 25% to 30% of college students are overweight or obese. Desai et al. also suggested rates of complete physical inactivity among college students is between 37% and 46%. Unfortunately, dietary practices among college students are not ideal either.
Poor nutritional behaviors also contribute to risk factors among this population. In a study among college freshman and sophomores, Racette, Deusinger, Strube, Highstein, and Deusinger found that 70% of the 764 college students assessed consumed less than the U.S. Department of Agriculture (USDA) recommendations of two servings of fruit and three servings of vegetables daily. Strikingly, approximately half of the students surveyed also reported high-fat fast or fried food consumption ≥ 3 times in the past week. Notably, a subsample of these students was assessed again a year later with 70% of these students gaining, on average, four kilograms. Indeed, other studies have demonstrated the impact poor dietary practices (e.g., consumption of "junk foods", sugar-sweetened beverages, or fast foods high in fat and low in nutrient density) and obesogenic environments (e.g., continuously eating at buffet-style student dining halls) can have on weight gain from freshman year of college onward. As such, not only is it clear that theoretically-backed physical activity interventions are needed among college students, there is also a distinct need to include a dietary component within these interventions. Technology integration within these physical activity and nutritional interventions among college students might present a viable approach.
While few empirical data is available regarding health wearable use among young adults, it is likely that this technology-savvy age cohort represents a large proportion of the one in six consumers currently owning a health wearable. Further, with the number of health wearables sold in 2018 projected to be 110 million, it is likely that this age cohort will contribute substantially to this figure. Moreover, research indicates the popularity of social media among young adults. Indeed, among individuals 18-29 years of age, approximately 90% use at least one social media site. Currently, Facebook represents the most widely used social media site with 1.71 billion active users and individuals 18 to 34 years of age representing the majority of Facebook users.
Therefore, the combined use of health wearable technology, these devices' associated smartphone applications, and a theoretically-driven health intervention delivered via social media, may prove appealing and effective as a health promotion strategy among college students. Specifically, use of the Polar M400 may increase college students' ability to self-regulate physical activity behaviors as self-regulation is posited as an important factor in promoting behavior change. Further, the Polar M400's associated smartphone application-based and Internet-based portal allows individuals to not only track physical activity-related metrics, but view predicted energy expenditure as well, which may allow individuals to self-regulate food intake in relation to daily energy expenditure. In combination with the Polar M400's capabilities, a twice-weekly Facebook-delivered Social Cognitive Theory-based health intervention may be able to increase college students' self-efficacy, outcome expectancy, enjoyment, and social support while decreasing barriers for participation in greater physical activity and nutritious eating behaviors. Relatedly, it is vital to also examine the preceding intervention's ability to promote changes in college students' intrinsic motivation for these health behaviors-an investigation which can be completed via application of the Self-Determination Theory.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Included exclusively in a separate, but content-identical, Facebook group for 12 weeks.
Behavioral: Facebook Only Group (FG)
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.
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.
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.
Time frame: "Change in Physical Activity from Baseline to 6 Weeks" and "Change in Physical Activity from Baseline to 12 Weeks"
Cardiovascular Fitness
Evaluated with YMCA 3-minute step test (Golding, Meyers, \& Sinning, 1998). Participants will step up and down for three minutes on a 12-inch riser to a metronome beep set at 96 beats per minute (each beep corresponding to one movement of the leg, with 4 beeps representing one "up-down" cycle). Participants' heart rate will be assessed immediately for one minute following the conclusion of the test by the researcher via palpation of the carotid/radial artery. The step test will be performed at baseline and 12 weeks to assess changes in cardiovascular fitness over time.
Time frame: "Change in Cardiovascular Fitness from Baseline to 12 Weeks"
Body Composition
Determined via bioelectrical impedance performed with the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan). Bioelectrical impedance sends a small electrical pulsatile wave through the body. Muscle is more conducive to electrical current transmission due to its higher water content versus fat meaning individuals with higher lean mass (i.e., lower body fat mass) will not impede the current to the degree of individuals with higher fat mass and therefore register lower body fat percentage values. Bioelectrical impedance has proven a valid measure of body composition in young adults enrolling in the military (Aandstad, Holtberget, Hageberg, Holme, \& Anderssen, 2014). Notably, to decrease variability in these body composition measurements, individuals will be asked to come in for testing at approximately the same time of day and having eaten/drank similar foods/beverages the night before as they did prior to previous session(s).
Time frame: "Change in Body Composition from Baseline to 12 Weeks"
Body Weight
Body Weight will be assessed using a calibrated weight scale: the Tanita BC-558 IRONMAN® Segmental Body Composition Monitor (Tanita, Tokyo, Japan).
Time frame: "Change in Weight from Baseline to 12 Weeks"
Self-Efficacy
Self-efficacy will be measured by a nine-question measure developed by Rodgers, Wilson, Hall, Fraser, and Murray (2008) wherein participants will rate how confident they feel in certain exercise situations (e.g., ..."exercise when you feel discomfort" or "...exercise when you lack energy") on a percentage scale (0%: not confident at all to 100%: extremely confident in 10% increments).
Time frame: "Change in Self-Efficacy from Baseline to 12 Weeks"
Social Support
Social support will be assessed using a five-question measure adapted from the Patient-Centered Assessment and Counseling for Exercise questionnaire, with participants rating on a five-point Likert-type scale (1: almost never to 5: almost always) how often significant others support/encourage them to be physically activity (Carlson et al., 2012).
Time frame: "Change in Social Support from Baseline to 12 Weeks"
Enjoyment
A 5-question measure developed by Harter et al. (1978) quantified PA enjoyment as college students noted agreement with statements such as "Engaging in physical activity is the thing I like to do best" on a 5-point Likert-type scale (1: strongly disagree to 5: strongly agree).
Time frame: "Change in Enjoyment from Baseline to 12 Weeks"
Barriers
A 14-question measure will evaluate participants' physical activity barriers, with participants asked to rate agreement between hypothetical barriers and their own barriers on a four-point Likert-type scale (1: strongly disagree to 4: strongly agree) (Sechrist, Walker, \& Pender, 1987).
Time frame: "Change in Barriers from Baseline to 12 Weeks"
Outcome Expectancy
Outcome expectancy will be assessed with a nine-question measure developed by Trost et al. (1997) using a five-point Likert-type scale (1: strongly disagree to 5: strongly agree) to evaluate participants' agreement with responses originating from the stem "If I was to exercise on most days it would...". Sample responses are "give me more energy" and "help to control my weight".
Time frame: "Change in Outcome Expectancy from Baseline to 12 Weeks"
Intrinsic Motivation
Will be evaluated using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (McAuley, Duncan, \& Tammen, 1987). This seven-question subscale requires participants to determent how true certain statements such as "I enjoyed this activity very much" and "I would describe this activity as interesting" are to them on a seven-point Likert-type scale (1: not at all true to 7: very true). The Intrinsic Motivation Inventory has demonstrated good validity in the assessment of intrinsic motivation during exercise (Deci, Eghrari, Patrick, \& Leone, 1994).
Time frame: "Change in Intrinsic Motivation from Baseline to 12 Weeks"
Nutritious Eating Behaviors
To assess participant eating behaviors, the National Cancer Institute's Automated Self-Administered (ASA) 24-hour Dietary Recall will be used requiring participants to recall all foods consumed within the past 24 hours. The ASA 24-hour Dietary Recall has been validated in previous research (Kipnis et al., 2003; Moshfegh et al., 2008). Participants will receive unique login information allowing them to access and complete the recall after which the researcher will be able to download and analyze the results. The ASA 24-hour Dietary recall will be administered three times on random dates during the seven days following baseline and post-intervention testing at 12 weeks, with participants notified during these testing sessions that they will be asked to complete this questionnaire. Concentration will be placed on examining changes in participants' fruit and vegetable consumption in addition to the participants' intake of fast food and sugar-sweetened beverages.
Time frame: "Change in Nutritious Eating Behaviors from Baseline to 12 Weeks"
Facebook-Delivered Health Intervention Adherence
Regardless of group allocation, adherence to the social media-delivered health intervention previously outlined will be tracked. Briefly, the researcher will determine whether the participants have checked the Facebook health tips twice weekly in two manners following the alert each participant will receive when a new post goes live on each groups' Facebook page. First, Facebook now has a "Seen By" function that automatically indicates and lists everyone who has interacted with a new posting within a private Facebook group. Second, the researcher will also ask participants to "Like" each of the postings they read. In this way, the researcher will keep a running tally of whether each participant checked the posting by reviewing the "Seen By" function and whether the individual "Liked" the posting. Only individuals listed both within the "Seen By" function and as having "Liked" the posting will be counted as having seen the health tips.
Time frame: "Assessed Weekly throughout 12-Week Intervention Period"
Plan to share: Undecided
Ran from Sep 2017 to primary completion in May 2018, 7 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 7 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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