Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults

June 25, 2019 updated by: Xenia Fischer, University of Basel
The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program.

Study Overview

Detailed Description

Physical inactivity (PI) adversely affects various non-communicable diseases (WHO, 2010) and has been recently entitled "the biggest public health problem of the 21th century" (Blair, 2009). Despite the strong evidence for physical activity (PA) related health benefits, one third of the world's population is physically inactive (Hallal et al., 2012). In Switzerland, 35% of the adults are not meeting the minimum recommendation of 2.5h moderate to vigorous activity per week (BASPO, 2013). Present PI patters accompanied with demographic changes and the burden of non-communicable diseases (WHO, 2010) constitute a notable challenge to the health-care system. Thus, effective prevention programs that engage individuals to become more physically active are needed and of public interest.

Regarding the application for a wide public, the use of technologies for a remote delivery of PA promotion programs is promising (Castro & King, 2002). Thereby, PA lifestyle interventions including individually tailored program components (Noar, Benac, & Harris, 2007), personal coaching (Foster, Richards, Thorogood, & Hillsdon, 2013), behavior change techniques (BCT) (Michie, Abraham, Whittington, McAteer, & Gupta, 2009) and regular prompting (push notifications) (De Leon, Fuentes, & Cohen, 2014) are regarded as effective means to improve PA behavior. However, it is still not examined to date, which intervention components could be effectively translated into practice. The required density, the most effective modality and long-term outcomes of PA promotion program need to be examined (Foster et al., 2013).

Within this study three versions to communicate an individually tailored PA promotion program will be compared. The program consists of individual counseling but is delivered without face-to-face contact. Exercise recommendations and behavior change techniques will be elaborated on an individual basis, communicated and assessed. The programs content will then be tailored according to personal background information (e.g. goals, preferences) assessed by questionnaires.

A personalized activity-profile on a specifically developed internet portal (on www.movingcall.com) enables safe exchange between participant and coach. The activity-profile includes a weekly activity plan, questionnaires and a diary to document daily PA behavior.

All enrolled participants will have access to a personal activity profile and receive a tailored advice to increase their physical activity levels. Depending on the interventional arm the advice will be delivered in a more supportive and interactive manner. Participants will be randomly assigned to one of the three study arms.

The primary objective is to assess the effect of regular coaching and prompting on PA level. Secondary objectives are the assessment of follow-up effects of PA changes and changes in psychosocial determinants of PA as well as the comparison self-reported and objectively assessed PA data.

Outcome measures will be assessed prior to the start of the intervention, at the end of the six months and in the follow-up period after 12 months.

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Birsstr. 320B
      • Basel, Birsstr. 320B, Switzerland, 4052
        • University of Basel, Department of Sport, Exercise and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • not meeting the physical activity guidelines of 150 minutes moderate or 75 minutes vigorous aerobic activity

Exclusion Criteria:

  • medical condition that contraindicates the participation in regular moderate-intensity exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Phone" group
see intervention description
Participants in the "phone" group receive 12 individually tailored coaching sessions (15 - 20 min). The coaching calls are scheduled biweekly. Participants receive their tailored advice via interactive counseling.
Experimental: "Phone and SMS" group
see intervention description
The "phone and SMS" group receive the same coaching as the "phone" group. They additionally receive two tailored SMS per week over the course of six months.
Active Comparator: "single writing" group
see intervention description
The control intervention consists of a "minimal credible" physical activity PA promotion program. Participants in the control group receive a singular written advice and an activity plan but no counseling by phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical activity level of one week
Time Frame: 6 months of intervention
Simple Physical Activity Questionnaire; SIMPAQ
6 months of intervention
Objectively assessed physical activity level of one week
Time Frame: 6 months of intervention
Accelerometer
6 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical activity level of one week
Time Frame: In the follow-up after 12 months
Simple Physical Activity Questionnaire; SIMPAQ
In the follow-up after 12 months
Objectively assessed physical activity level of one week
Time Frame: In the follow-up after 12 months
Accelerometer
In the follow-up after 12 months
body weight
Time Frame: At baseline, 6 months and in the follow-up after 12 months
At baseline, 6 months and in the follow-up after 12 months
health related quality of life (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Health related quality of life will be assessed by the Short Form 12 Questionnaire (SF-12) (Bullinger, 1995; Ware, Kosinski, & Keller, 1996). The questionnaire includes 12 items on general physical health status and mental health distress.
At baseline, 6 months and in the follow-up after 12 months
stress-related exhaustion symptoms (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Perceived stress-related exhaustion symptoms will be measured by the validated Shirom-Melamed Burnout Measure (SMBM) (Shirom & Melamed, 2006).
At baseline, 6 months and in the follow-up after 12 months
Adherence to the PA promotion program (count data)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Adherence will be calculated by the frequency of logins to the personal profile and the frequency of entering self-monitoring data.
At baseline, 6 months and in the follow-up after 12 months
Satisfaction with the program (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
A self-compiled questionnaire will be used to assess general satisfaction, motivation to continue with the program, comprehensibility of the profile and suggestions for future improvements of the program.
At baseline, 6 months and in the follow-up after 12 months
Intention on physical activity participation (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Motivational readiness will be assessed according to the stages of change of the Transtheoretical Model (Fuchs, 2007; Marcus, Rakowski, & Rossi, 1992).
At baseline, 6 months and in the follow-up after 12 months
Outcome expectations on physical activity participation (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Outcome expectancies regarding the physical activity will be assessed with eight items according to Fuchs (1994).
At baseline, 6 months and in the follow-up after 12 months
Self-efficacy concerning physical activity participation (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Consistent with Fuchs (2008), self-efficacy will be assess by the confidence to begin, to maintain and to restart regular physical activity.
At baseline, 6 months and in the follow-up after 12 months
Barriers concerning physical activity participation (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Perceived barriers: Participants will be presented a list of 19 potential barriers and asked to indicate how strong each one prevented physical activity (Fuchs, Seelig, Gohner, Burton, & Brown, 2012)
At baseline, 6 months and in the follow-up after 12 months
Social support for physical activity participation (questionnaire)
Time Frame: At baseline, 6 months and in the follow-up after 12 months
Social support will be assessed by 7 items that rate the confidence for support of the social environment (Fuchs, 1997).
At baseline, 6 months and in the follow-up after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lukas Zahner, Prof. Dr., Department of Sport, Exercise and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-00560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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