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Health BehaviorMAPSNCT02592590

Multiphase Activity Promotion Study

A study testing Group A, Group B and Group C in people with Health Behavior and Sedentary Lifestyle, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the individual and combined effectiveness of two smartphone-based tools for improving physical activity. The first is an individualized and guided goal-setting module, and the second uses "points", "levels", and "badges" to provide instant positive feedback throughout the… Read more about this study

Who is it for?
Ages 30 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Health Behavior, Sedentary Lifestyle
What is being tested?
Group A, Group B and Group C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
Nov 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 30-54 years;
  • Own an Apple iPhone or Android smartphone;
  • Have consistent access to mobile internet and text messaging;
  • Are low-active (i.e., do not engage in 30 or more minutes of moderate to vigorous physical activity on two or more days per week).

Who cannot join

  • Inability to communicate in English;
  • Presence of cognitive impairment;
  • Presence of any medical contraindication to exercise;
  • Inability to walk without assistance;
  • Enrollment in another physical activity study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Illinois at Urbana-Champaign

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: A Social-Cognitive Smartphone Application for Improving Physical Activity in Adults

The purpose of this study is to determine the individual and combined effectiveness of two smartphone-based tools for improving physical activity. The first is an individualized and guided goal-setting module, and the second uses "points", "levels", and "badges" to provide instant positive feedback throughout the program. It is hypothesized that both components will be effective, and greater effects will be noted for those receiving both components.

Read the detailed description

The purpose of the proposed study is to test the efficacy of individual components of a smartphone application designed using theories of human behavior to promote physical activity in low-active adults. Smartphones have become commonplace: approximately two-thirds of adults own a smartphone. They allow for wireless internet connectivity and the ability to communicate via voice and text message at any time. Perhaps most importantly from the perspective of behavior change, the devices are often carried on the person at all times. In recent years researchers have attempted to use these devices to promote physical activity, but continue to encounter a number of barriers. Notably, development in the commercial sector far outpaces the standard randomized controlled trial (RCT) cycle. As a result, researchers utilizing RCT designs find it difficult to publish findings that are relevant to current technology. Additionally, this approach typically examines a full application that includes a package of features, making it difficult to draw conclusions about single intervention components. This has resulted in a commercial sector that produces a large number of physical activity applications that are not evidence based. The present study uses a factorial design to study the individual and combined efficacy of two theory-based modules: A guided goal-setting module, and a points-based feedback system. If successful, the results of this study will help to guide a fast-moving commercial sector toward the development evidence-based applications, which has the potential to yield a large public health impact.

To test these aims, adults will be recruited from Champaign-Urbana, IL, and surrounding communities to participate in a 12-week home-based and self-guided physical activity program. Eligible individuals will complete baseline questionnaires and informed consent online, and will wear an activity monitor for one week. Upon completion of questionnaires, participants will be randomly assigned to one of four conditions:

  1. . The Base-App (BA) condition (i.e., Group D; so named due to the factorial design used in this study) will receive only a base-level smartphone app that contains three components common in computerized behavioral interventions: physical activity-related educational content (i.e., weekly videos, additional resources, easy weekly quiz questions), manual physical activity tracking, and instantaneous graphical feedback. As the physical activity program is goal-directed, these individuals will also receive printed goal setting worksheets.
  2. . The BA+PT condition (i.e., Group C) will receive the Base-App plus an instantaneous points-based feedback module (PT) that provides "program points" for every task in the application (e.g., tracking physical activities, watching educational videos), and these are weighted by difficulty of the task. Points accumulate to earn "levels", and every fifth level brings a new motivational prompt and "badge" depicting an initially unfit character becoming increasing fit. Every tenth level will earn the participant a new "title" (e.g., "Intermediate Exerciser"). These points, levels, badges, and titles serve to provide instant positive feedback on progress within the program. These individuals will also receive printed goal setting worksheets.
  3. . The BA+GS condition (i.e., Group B) will receive the Base-App plus a fully guided goal-setting module (GS). This module is based upon health behavior theory, emphasizing gradual exercise progression and highly specific, realistic, and measurable goals. The module will guide participants in setting both long and short term goals: each week, those with access to the GS module will be prompted to revisit and reset their goals. At this time, participants will select several aerobic and non-aerobic activities for the week, and will set a frequency (days per week) and duration (minutes per session) for each type of activity. To emphasize gradual progression, participants will receive a minimum, maximum, and recommended frequency and duration, and these will be calculated automatically within the app based upon performance in previous weeks.
  4. . The BA+GS+PT condition (i.e., Group A) will receive all application components (i.e., Base-App, goal setting, instantaneous feedback). In addition to the features described above, program points accompany goal-related tasks (i.e., setting goals, revisiting goals, achieving goals).

Following completion of questionnaires, all participants will attend a group-specific orientation session. During this session, trained research staff will provide an introduction to the smartphone application used in the study and all relevant features, as well as a one-on-one physical activity counseling session in which staff members will work with participants to set initial aerobic and non-aerobic physical activity goals. During this time, participants will also be introduced to the goal-directed nature of the MAPS physical activity program. Short term (i.e., weekly) goals will specify the types of aerobic and non-aerobic activities that the individual will engage in, as well as the frequency and duration with which they will engage in these activities. Each participant's initial long-term goal will reflect federal physical activity recommendations. Accordingly, each participant will work toward achieving 150 minutes of moderate intensity aerobic activity, and at least two days of full-body muscle strengthening exercises within the 12-week intervention period. Staff will work with participants to modify these long-term goals based upon the participant's current abilities and physical activity level.

The program will begin on the Sunday following the orientation session. On each Sunday of the program, a new educational module related to basic health and health behavior concepts will be released, and participants will receive a brief email containing information related to the weekly educational content with a reminder to watch the new video. With the exception of the first week, these emails will also provide specific feedback (i.e., minutes of exercise, average intensity, and average enjoyment) from the previous week, and for those with access to guided goal setting the email will also provide feedback and advice based on whether or not the previous week's goals were met. Finally, each email will prompt the participant to revisit their short and long term goals, and adjust them as necessary. At this time, participants with the guided goal setting module will be brought immediately to that module upon entering the app, and will be asked to revisit and reset their short term goals. This process will include a recommended frequency and duration based upon previous performance in the program. Participants will also be prompted to set a new long term goal in the event that they achieved their previous long term goal during the week. For those without guided goal setting, this process will be carried out using traditional printed goal setting worksheets.

During each week, participants will utilize application features to track exercises as they do them, view their feedback, review their weekly goals, and view educational content. On each Thursday, participants will receive a text message update based upon their progress during the week. For those who have not accessed the app during the week, and for those who have not yet tracked activity during the week, a brief prompt will remind them to do so. For those who have tracked activity, a brief message will provide for them an update on the number of sessions and minutes of activity for the week.

During the final week of the program, participants will once again receive the activity monitor via mail and will be asked to wear it for one week. On completion of the 12-week program, participants will receive an email informing them that the program has completed. This email will also provide a link to follow-up questionnaires. At this time, research staff will also contact the participant to schedule a follow-up appointment, which will take no more than 60 minutes. During this appointment, participants will return the activity monitor and will complete a post-study survey assessing their experiences with the MAPS program and with the MAPS research staff.

Being tested
Group A, Group B, Group C, Group D
Keywords
Exercise, Physical Activity, Smartphone, Technology
Medical subject headings
Health Behavior, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group ABehavioural

    Also called Base-App, Goal-Setting, Points-Based Feedback

    This condition receives three study components:

    1. The base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, quiz questions), activity tracking, and graphical feedback.
    2. The guided goal-setting module within the app that utilizes participant activity preferences and experiences, as well as performance within the program to guide the setting of high-quality short and long-term physical activity goals. These goals form the basis of the physical activity prescription.
    3. The points-based feedback module. For each action in the app (e.g., setting goals, achieving goals, viewing weekly videos, answering quiz questions, tracking activity), a number of "program points" is awarded. These are weighted by task difficulty, and accumulate to earn "levels". Levels accumulate to earn "badges" depicting an avatar becoming increasingly healthy and active. Badges accumulate to earn "titles" (e.g., "expert exerciser").
  • Group BBehavioural

    Also called Base-App, Goal-Setting

    This condition receives two study components:

    1. The first is the base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback.
    2. The second is the guided goal-setting module within the app that utilizes participant activity preferences and experiences, as well as performance within the program to guide the setting of high-quality short and long-term physical activity goals. These goals form the basis of the physical activity prescription.
  • Group CBehavioural

    Also called Base-App, Points-Based Feedback

    This condition receives two study components:

    1. The first is the base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback.
    2. The second is the points-based feedback module. For each action in the app (e.g., viewing weekly videos, answering quiz questions, tracking activity), a number of "program points" is awarded. These are weighted by task difficulty, and accumulate to earn "levels". Levels accumulate to earn "badges" depicting an avatar becoming increasingly healthy and active. Badges accumulate to earn "titles" (e.g., "expert exerciser"). As the intervention is goal drive, these participants will also receive printed goal setting worksheets.
  • Group DBehavioural

    Also called Base-App Only

    This condition receives only the base-level smartphone app. This contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback. As the intervention is goal drive, these participants will also receive printed goal setting worksheets.

Study groups in NCT02592590
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Behavioral: Group A
Group BExperimentalNot described
Receives: Behavioral: Group B
Group CExperimentalNot described
Receives: Behavioral: Group C
Group DActive comparatorNot described
Receives: Behavioral: Group D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in accelerometer-measured physical activity from baseline to month three

    In the week prior to the start of the program and in the twelfth week of the program, participants will wear an actigraph brand accelerometer on their hip during waking hours for seven consecutive days.

    Measured: Baseline and Three Months

Secondary outcomes (3)
  1. Change in psychosocial outcomes from baseline to month three as assessed by psychosocial questionnaires.

    In the week prior to the start of the program and in the twelfth week of the program, participants will complete a short battery of online psychosocial questionnaires. The investigators will then examined whether study group placement influences levels on any of these variables.

    Measured: Baseline and Three Months

  2. Number of days of program use per participant over the course of the intervention as assessed via program log-in.

    The investigators will monitor participant application use by assessing the number of day in which each participant logs into the application over the course of the study period. The investigators will then examine whether study group placement influences the length of time that an individual uses the application.

    Measured: Three Months

  3. Program usability and acceptability

    To assess usability and acceptability of the study application, participants will complete a brief program evaluation upon completion of the study. This will assess the ease of use and level of enjoyment associated with the three month program.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionApr 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592590
Sponsor's protocol ID
UIUC IRB #16257
Acronym
MAPS
Status last verified
Oct 2016
First submitted
28 Oct 2015
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • McAuley E. The role of efficacy cognitions in the prediction of exercise behavior in middle-aged adults. J Behav Med. 1992 Feb;15(1):65-88. doi: 10.1007/BF00848378.

    PubMed 1583674
  • McAuley E, Lox C, Duncan TE. Long-term maintenance of exercise, self-efficacy, and physiological change in older adults. J Gerontol. 1993 Jul;48(4):P218-24. doi: 10.1093/geronj/48.4.p218.

    PubMed 8315239
  • McAuley E, Hall KS, Motl RW, White SM, Wojcicki TR, Hu L, Doerksen SE. Trajectory of declines in physical activity in community-dwelling older women: social cognitive influences. J Gerontol B Psychol Sci Soc Sci. 2009 Sep;64(5):543-50. doi: 10.1093/geronb/gbp049. Epub 2009 Jun 15.

    PubMed 19528360
  • Rogers LQ, Shah P, Dunnington G, Greive A, Shanmugham A, Dawson B, Courneya KS. Social cognitive theory and physical activity during breast cancer treatment. Oncol Nurs Forum. 2005 Jul 1;32(4):807-15. doi: 10.1188/05.ONF.807-815.

    PubMed 15990910
  • Wojcicki TR, White SM, McAuley E. Assessing outcome expectations in older adults: the multidimensional outcome expectations for exercise scale. J Gerontol B Psychol Sci Soc Sci. 2009 Jan;64(1):33-40. doi: 10.1093/geronb/gbn032. Epub 2009 Jan 29.

    PubMed 19181688
  • Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.

    PubMed 12054320
  • Bandura A. Human agency in social cognitive theory. Am Psychol. 1989 Sep;44(9):1175-84. doi: 10.1037/0003-066x.44.9.1175.

    PubMed 2782727
  • Collins LM, Dziak JJ, Kugler KC, Trail JB. Factorial experiments: efficient tools for evaluation of intervention components. Am J Prev Med. 2014 Oct;47(4):498-504. doi: 10.1016/j.amepre.2014.06.021. Epub 2014 Aug 1.

    PubMed 25092122
  • Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

    PubMed 17466815
  • Fanning J, Roberts S, Hillman CH, Mullen SP, Ritterband L, McAuley E. A smartphone "app"-delivered randomized factorial trial targeting physical activity in adults. J Behav Med. 2017 Oct;40(5):712-729. doi: 10.1007/s10865-017-9838-y. Epub 2017 Mar 2.

    PubMed 28255750

Questions about this trial

What is this clinical trial studying?

A study testing Group A, Group B and Group C in people with Health Behavior and Sedentary Lifestyle, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in accelerometer-measured physical activity from baseline to month three (time frame: Baseline and Three Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592590, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.

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