NCT02592590

Brief 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 program. It is hypothesized that both components will be effective, and greater effects will be noted for those receiving both components.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 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

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

October 28, 2015

Last Update Submit

October 28, 2016

Conditions

Health BehaviorSedentary Lifestyle

Keywords

ExercisePhysical ActivitySmartphoneTechnology

Outcome Measures

Primary Outcomes (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.

    Baseline and Three Months

Secondary Outcomes (3)

  • Change in psychosocial outcomes from baseline to month three as assessed by psychosocial questionnaires.

    Baseline and Three Months

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

    Three Months

  • Program usability and acceptability

    Month 3

Study Arms (4)

Group A

EXPERIMENTAL
Behavioral: Group A

Group B

EXPERIMENTAL
Behavioral: Group B

Group C

EXPERIMENTAL
Behavioral: Group C

Group D

ACTIVE COMPARATOR
Behavioral: Group D

Interventions

Group ABEHAVIORAL

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").

Also known as: Base-App, Goal-Setting, Points-Based Feedback
Group A
Group BBEHAVIORAL

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.

Also known as: Base-App, Goal-Setting
Group B
Group CBEHAVIORAL

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.

Also known as: Base-App, Points-Based Feedback
Group C
Group DBEHAVIORAL

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.

Also known as: Base-App Only
Group D

Eligibility Criteria

Age30 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (10)

  • 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.

    PMID: 1583674BACKGROUND

  • 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.

    PMID: 8315239BACKGROUND

  • 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.

    PMID: 19528360BACKGROUND

  • 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.

    PMID: 15990910BACKGROUND

  • 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.

    PMID: 19181688BACKGROUND

  • 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.

    PMID: 12054320BACKGROUND

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

    PMID: 2782727BACKGROUND

  • 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.

    PMID: 25092122BACKGROUND

  • 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.

    PMID: 17466815BACKGROUND

  • 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.

    PMID: 28255750DERIVED

Related Links

MeSH Terms

Conditions

Health BehaviorSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Edward McAuley, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)