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Completed

NCT Number: NCT02918578

Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults

The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Department of Sport, Exercise and Health

Basel, Birsstr. 320B, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Phone" group

Other

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.

"Phone and SMS" group

Other

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.

"single writing" group

Other

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.

Primary outcomes

  1. Self-reported physical activity level of one week

    Time frame: 6 months of intervention

    Simple Physical Activity Questionnaire; SIMPAQ

  2. Objectively assessed physical activity level of one week

    Time frame: 6 months of intervention

    Accelerometer

Secondary outcomes

  1. Self-reported physical activity level of one week

    Time frame: In the follow-up after 12 months

    Simple Physical Activity Questionnaire; SIMPAQ

  2. Objectively assessed physical activity level of one week

    Time frame: In the follow-up after 12 months

    Accelerometer

  3. body weight

    Time frame: At baseline, 6 months and in the follow-up after 12 months

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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).

  9. 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).

  10. 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.

  11. 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)

  12. 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).

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2016
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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