Team Science to Promote Physical Activity

NCT ID: NCT03906942

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2020-04-02

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].

Conditions

Health Promotion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Fun For Wellness (FFW)

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 of 24 hr access to the FFW online intervention during data collection for this study. Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being and/or physical activity.

Group Type: EXPERIMENTAL

Fun For Wellness (FFW)

Intervention Type: BEHAVIORAL

FFW consists of videos, games, and content in the form of 152 BET I CAN challenges \[1\]. Behavior challenges are intended to increase a participant's capabilities to set a goal and to create positive habits. Emotion challenges are intended to increase a participant's capabilities to cope with negative emotions and to cultivate positive emotions. Thought challenges are intended to increase a participant's capabilities to challenge negative assumptions and to create a new narrative for their life. Interaction challenges are intended to increase a participant's capabilities to communicate and connect with others. Context challenges are intended to increase a participant's capabilities to read cues and to change cues in the environment. Awareness challenges are intended to increase a participant's capabilities to know herself/himself and to know the issue. Next steps challenges are intended to increase a participant's capabilities to make a plan and to stick with a plan.

Usual Care (UC)

Participants assigned to the UC group (i.e., UC participants) will proceed through the pre-operative weight management program provided by the center.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fun For Wellness (FFW)

FFW consists of videos, games, and content in the form of 152 BET I CAN challenges \[1\]. Behavior challenges are intended to increase a participant's capabilities to set a goal and to create positive habits. Emotion challenges are intended to increase a participant's capabilities to cope with negative emotions and to cultivate positive emotions. Thought challenges are intended to increase a participant's capabilities to challenge negative assumptions and to create a new narrative for their life. Interaction challenges are intended to increase a participant's capabilities to communicate and connect with others. Context challenges are intended to increase a participant's capabilities to read cues and to change cues in the environment. Awareness challenges are intended to increase a participant's capabilities to know herself/himself and to know the issue. Next steps challenges are intended to increase a participant's capabilities to make a plan and to stick with a plan.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Sparrow Health System

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Myers

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas D Myers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Isaac Prilleltensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Sparrow Health System Bariatric Services

East Lansing, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28303422 (View on PubMed)

Bandura A. Self-efficacy: the exercise of control. New York: Freeman; 1997.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 29708773 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26978655 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27777223 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27976755 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25539733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18760161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10993415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12900694 (View on PubMed)

ClinicalTrials.gov: Well-Being and Physical Activity Study. https://clinicaltrials.gov/ct2/show/NCT 03194854 Accessed 9 January 2019.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 31164990 (View on PubMed)

Other Identifiers

STUDY00002012

Identifier Type: -

Identifier Source: org_study_id