Clinical trial NCT03906942: Team Science to Promote Physical Activity
Official title: Using Team Science to Promote Health-Enhancing Physical Activity in Adults With Obesity in a Community Setting: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Sparrow Health System
First posted: 2019-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the Fun For Wellness (FFW) group or the Usual Care (i.e., UC) group by the code programmed within the FFW website that is specified to achieve a 1:1 group (i.e., nFFW = 15, nUC = 15) assignment. Participants assigned to the UC group (i.e., UC participants) will proceed through the pre-operative weight management program provided by the center. Participants assigned to the FFW group (i.e., FFW participants) will proceed through the pre-operative program provided by the center and will be given 4 weeks (i.e., Week 3 through Week 6) of 24 hr access to the FFW online intervention during data collection for this study.
Primary purpose: OTHER

Brief summary: Background: Fun For Wellness is an online intervention designed to promote growth in well-being and physical activity by providing confidence-enhancing learning opportunities to participants.

Objective: The objective of this feasibility study is to address uncertainties regarding the inclusion of accelerometer-based assessment of physical activity within the Fun For Wellness online intervention among free-living adults with obesity in the United States of America.

Method: The study design is a prospective, double-blind, parallel group randomized pilot trial.

Discussion: Results are intended to inform the preparation of a future definitive randomized controlled trial.

Detailed description: Fun For Wellness is an online intervention designed to promote growth in well-being and physical activity by providing confidence-enhancing learning opportunities to participants \[1\]. The conceptual framework for the Fun For Wellness intervention is guided by self-efficacy theory \[2\]. Evidence has been provided for the efficacy of Fun For Wellness to promote self-reported physical well-being actions in free-living adults who comply with the intervention \[3\]. The objective of this feasibility study is to address uncertainties regarding the inclusion of accelerometer-based assessment of physical activity within the Fun For Wellness online intervention among free-living adults with obesity in the United States of America.

Four specific aims will be investigated. Aim 1. To determine if accelerometer-based assessment of physical activity can be used within the Fun For Wellness intervention.

Aim 2. To determine if accelerometer-based assessment of physical activity should be used within the Fun For Wellness intervention.

Aim 3. To determine how to implement accelerometer-based assessment of physical activity within the Fun For Wellness intervention.

Aim 4. To provide a preliminary effect size estimate for each direct effect in the conceptual model for the Fun For Wellness online intervention.

Pursuit of these four specific aims is based on a general conceptual framework for feasibility and pilot studies in preparation for a future definitive randomized controlled trial \[4-6\]. Within this conceptual framework, a randomized pilot trial is a type of a feasibility study and a feasibility study may include a focus on the acceptability of an intervention \[4-6\].

Eligibility criteria: Inclusion Criteria:

Individual is at least 18 years old but not older than 64 years old. Individual has a body mass index (BMI) ≥ 25.00 kg/m2. Individual has access to a technological device (e.g., computer) that can access the online intervention.

Individual is not simultaneously enrolled in another program promoting either well-being or physical activity.

Individual is willing to comply with instructions for physical activity monitoring.

Exclusion Criteria:

Individual is less than 18 years old or older than 64 years old. Individual has a body mass index (BMI) \< 25.00. Individual does not have access to a technological device (e.g., computer) that can access the online intervention.

Individual is simultaneously enrolled in another program promoting either well-being or physical activity.

Individual is unwilling to comply with instructions for physical activity monitoring.

Primary outcomes:
measure: feasibility of accelerometer-based assessment of physical activity (recruitment rate)
timeFrame: Week 0
measure: feasibility of accelerometer-based assessment of physical activity (eligibility rate)
timeFrame: Week 0
measure: feasibility of accelerometer-based assessment of physical activity (consent rate)
timeFrame: Week 0
measure: self-efficacy to comply
timeFrame: Week 1
measure: well-being self-efficacy (interpersonal sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (community sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (occupational sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (physical sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (psychological sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (economic sub-scale)
timeFrame: Week 1
measure: well-being self-efficacy (overall sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (interpersonal sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (community sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (occupational sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (physical sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (psychological sub-scale)
timeFrame: Week 1
measure: well-being actions self-efficacy (economic sub-scale)
timeFrame: Week 1
measure: subjective well-being (interpersonal sub-scale)
timeFrame: Week 1
measure: subjective well-being (community sub-scale)
timeFrame: Week 1
measure: subjective well-being (occupational sub-scale)
timeFrame: Week 1
measure: subjective well-being (physical sub-scale)
timeFrame: Week 1
measure: subjective well-being (psychological sub-scale)
timeFrame: Week 1
measure: subjective well-being (economic sub-scale)
timeFrame: Week 1
measure: subjective well-being (overall sub-scale)
timeFrame: Week 1
measure: well-being actions (interpersonal sub-scale)
timeFrame: Week 1
measure: well-being actions (community sub-scale)
timeFrame: Week 1
measure: well-being actions (occupational sub-scale)
timeFrame: Week 1
measure: well-being actions (physical sub-scale)
timeFrame: Week 1
measure: well-being actions (psychological sub-scale)
timeFrame: Week 1
measure: well-being actions (economic sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (job-related vigorous sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (transportation-related vigorous sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (leisure-related vigorous sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (job-related moderate sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (transportation-related moderate sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (domestic and gardening-related moderate sub-scale)
timeFrame: Week 1
measure: physical activity self-efficacy (leisure-related moderate sub-scale)
timeFrame: Week 1
measure: Self-efficacy to regulate physical activity
timeFrame: Week 1
measure: physical activity (Fitbit Zip)
timeFrame: Week 2
measure: physical activity (Actigraph wGT3X-BT)
timeFrame: Week 2
measure: self-reported physical activity
timeFrame: Week 2
measure: feasibility of accelerometer-based assessment of physical activity (participation rate)
timeFrame: Week 2
measure: acceptability of accelerometer-based assessment of physical activity (quantitative)
timeFrame: Week 3
measure: acceptability of accelerometer-based assessment of physical activity (qualitative)
timeFrame: Week 3
measure: well-being self-efficacy (interpersonal sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (community sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (occupational sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (physical sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (psychological sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (economic sub-scale)
timeFrame: Week 7
measure: well-being self-efficacy (overall sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (interpersonal sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (community sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (occupational sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (physical sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (psychological sub-scale)
timeFrame: Week 7
measure: well-being actions self-efficacy (economic sub-scale)
timeFrame: Week 7
measure: subjective well-being (interpersonal sub-scale)
timeFrame: Week 7
measure: subjective well-being (community sub-scale)
timeFrame: Week 7
measure: subjective well-being (occupational sub-scale)
timeFrame: Week 7
measure: subjective well-being (physical sub-scale)
timeFrame: Week 7
measure: subjective well-being (psychological sub-scale)
timeFrame: Week 7
measure: subjective well-being (economic sub-scale)
timeFrame: Week 7
measure: subjective well-being (overall sub-scale)
timeFrame: Week 7
measure: well-being actions (interpersonal sub-scale)
timeFrame: Week 7
measure: well-being actions (community sub-scale)
timeFrame: Week 7
measure: well-being actions (occupational sub-scale)
timeFrame: Week 7
measure: well-being actions (physical sub-scale)
timeFrame: Week 7
measure: well-being actions (psychological sub-scale)
timeFrame: Week 7
measure: well-being actions (economic sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (job-related vigorous sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (transportation-related vigorous sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (leisure-related vigorous sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (job-related moderate sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (transportation-related moderate sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (domestic and gardening-related moderate sub-scale)
timeFrame: Week 7
measure: physical activity self-efficacy (leisure-related moderate sub-scale)
timeFrame: Week 7
measure: Self-efficacy to regulate physical activity
timeFrame: Week 7
measure: physical activity (Actigraph wGT3X-BT)
timeFrame: Week 8
measure: self-reported physical activity
timeFrame: Week 8
measure: physical activity (Fitbit Zip)
timeFrame: Week 8
measure: feasibility of accelerometer-based assessment of physical activity (participation rate)
timeFrame: Week 8
measure: feasibility of accelerometer-based assessment of physical activity (retention rate)
timeFrame: Week 8
measure: acceptability of accelerometer-based assessment of physical activity (quantitative)
timeFrame: Week 9
measure: acceptability of accelerometer-based assessment of physical activity (qualitative)
timeFrame: Week 9
measure: well-being self-efficacy (interpersonal sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (community sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (occupational sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (physical sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (psychological sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (economic sub-scale)
timeFrame: Week 11
measure: well-being self-efficacy (overall sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (interpersonal sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (community sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (occupational sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (physical sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (psychological sub-scale)
timeFrame: Week 11
measure: well-being actions self-efficacy (economic sub-scale)
timeFrame: Week 11
measure: subjective well-being (interpersonal sub-scale)
timeFrame: Week 11
measure: subjective well-being (community sub-scale)
timeFrame: Week 11
measure: subjective well-being (occupational sub-scale)
timeFrame: Week 11
measure: subjective well-being (physical sub-scale)
timeFrame: Week 11
measure: subjective well-being (psychological sub-scale)
timeFrame: Week 11
measure: subjective well-being (economic sub-scale)
timeFrame: Week 11
measure: subjective well-being (overall sub-scale)
timeFrame: Week 11
measure: well-being actions (interpersonal sub-scale)
timeFrame: Week 11
measure: well-being actions (community sub-scale)
timeFrame: Week 11
measure: well-being actions (occupational sub-scale)
timeFrame: Week 11
measure: well-being actions (physical sub-scale)
timeFrame: Week 11
measure: well-being actions (psychological sub-scale)
timeFrame: Week 11
measure: well-being actions (economic sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (job-related vigorous sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (transportation-related vigorous sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (leisure-related vigorous sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (job-related moderate sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (transportation-related moderate sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (domestic and gardening-related moderate sub-scale)
timeFrame: Week 11
measure: physical activity self-efficacy (leisure-related moderate sub-scale)
timeFrame: Week 11
measure: Self-efficacy to regulate physical activity
timeFrame: Week 11
measure: physical activity (Fitbit Zip)
timeFrame: Week 12
measure: physical activity (Actigraph wGT3X-BT)
timeFrame: Week 12
measure: self-reported physical activity
timeFrame: Week 12
measure: feasibility of accelerometer-based assessment of physical activity (participation rate)
timeFrame: Week 12
measure: feasibility of accelerometer-based assessment of physical activity (retention rate)
timeFrame: Week 12
measure: acceptability of accelerometer-based assessment of physical activity (quantitative)
timeFrame: Week 13
measure: acceptability of accelerometer-based assessment of physical activity (qualitative)
timeFrame: Week 13
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Sparrow Health System Bariatric Services
state: Michigan
Study officials:
affiliation: Michigan State University
name: Nicholas D Myers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Isaac Prilleltensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myers ND, Prilleltensky I, Prilleltensky O, McMahon A, Dietz S, Rubenstein CL. Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial. Prev Sci. 2017 Nov;18(8):984-994. doi: 10.1007/s11121-017-0779-z.
citation: Bandura A. Self-efficacy: the exercise of control. New York: Freeman; 1997.
citation: Myers ND, Dietz S, Prilleltensky I, Prilleltensky O, McMahon A, Rubenstein CL, Lee S. Efficacy of the Fun For Wellness Online Intervention to Promote Well-Being Actions: A Secondary Data Analysis. Games Health J. 2018 Aug;7(4):225-239. doi: 10.1089/g4h.2017.0132. Epub 2018 Apr 30.
citation: Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
citation: Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Erratum to: Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 Jul 19;2:35. doi: 10.1186/s40814-016-0078-7. eCollection 2016.
citation: Tully MA, McBride C, Heron L, Hunter RF. The validation of Fibit Zip physical activity monitor as a measure of free-living physical activity. BMC Res Notes. 2014 Dec 23;7:952. doi: 10.1186/1756-0500-7-952.
citation: Hale LA, Pal J, Becker I. Measuring free-living physical activity in adults with and without neurologic dysfunction with a triaxial accelerometer. Arch Phys Med Rehabil. 2008 Sep;89(9):1765-71. doi: 10.1016/j.apmr.2008.02.027.
citation: Ainsworth BE, Bassett DR Jr, Strath SJ, Swartz AM, O'Brien WL, Thompson RW, Jones DA, Macera CA, Kimsey CD. Comparison of three methods for measuring the time spent in physical activity. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S457-64. doi: 10.1097/00005768-200009001-00004.
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: ClinicalTrials.gov: Well-Being and Physical Activity Study. https://clinicaltrials.gov/ct2/show/NCT 03194854 Accessed 9 January 2019.
citation: Prilleltensky I, Dietz S, Prilleltensky O, Myers ND, Rubenstein CL, Jin Y, et al. Assessing multidimensional well-being: development and validation of the I COPPE scale. J Community Psychol. 2015;43:199-226.
citation: Rubenstein CL. Assessing actions and feelings related to multidimensional well-being: validation of the I COPPE actions and feelings scales. 2017. https://scholarlyrepository.miami.edu/oa_dissertations/1942. Accessed 1 July 2018.
citation: Myers ND, Lee S, Bateman AG, Prilleltensky I, Clevenger KA, Pfeiffer KA, Dietz S, Prilleltensky O, McMahon A, Brincks AM. Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study. Pilot Feasibility Stud. 2019 May 31;5:73. doi: 10.1186/s40814-019-0455-0. eCollection 2019.