Sedentary LifestyleNCT02918578
Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults
A study testing "Phone" group, "Phone and SMS" group and "single writing" group in people with Sedentary Lifestyle, run by University of Basel at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- "Phone" group, "Phone and SMS" group and "single writing" group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not meeting the physical activity guidelines of 150 minutes moderate or 75 minutes vigorous aerobic activity
Who cannot join
- medical condition that contraindicates the participation in regular moderate-intensity exercise
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Department of Sport, Exercise and Health
Basel, Birsstr. 320B, 4052
About this study
The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- "Phone" group, "Phone and SMS" group, "single writing" group
- Keywords
- Physical Inactivity, Behavior Change
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Phone" groupOther
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" groupOther
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" groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "Phone" group | Experimental | see intervention description Receives: Other: "Phone" group |
| "Phone and SMS" group | Experimental | see intervention description Receives: Other: "Phone and SMS" group |
| "single writing" group | Active comparator | see intervention description Receives: Other: "single writing" group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical activity level of one week
Simple Physical Activity Questionnaire; SIMPAQ
Measured: 6 months of intervention
Objectively assessed physical activity level of one week
Accelerometer
Measured: 6 months of intervention
Secondary outcomes (12)
Self-reported physical activity level of one week
Simple Physical Activity Questionnaire; SIMPAQ
Measured: In the follow-up after 12 months
Objectively assessed physical activity level of one week
Accelerometer
Measured: In the follow-up after 12 months
body weight
Measured: At baseline, 6 months and in the follow-up after 12 months
health related quality of life (questionnaire)
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.
Measured: At baseline, 6 months and in the follow-up after 12 months
stress-related exhaustion symptoms (questionnaire)
Perceived stress-related exhaustion symptoms will be measured by the validated Shirom-Melamed Burnout Measure (SMBM) (Shirom \& Melamed, 2006).
Measured: At baseline, 6 months and in the follow-up after 12 months
Adherence to the PA promotion program (count data)
Adherence will be calculated by the frequency of logins to the personal profile and the frequency of entering self-monitoring data.
Measured: At baseline, 6 months and in the follow-up after 12 months
Satisfaction with the program (questionnaire)
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.
Measured: At baseline, 6 months and in the follow-up after 12 months
Intention on physical activity participation (questionnaire)
Motivational readiness will be assessed according to the stages of change of the Transtheoretical Model (Fuchs, 2007; Marcus, Rakowski, \& Rossi, 1992).
Measured: At baseline, 6 months and in the follow-up after 12 months
Outcome expectations on physical activity participation (questionnaire)
Outcome expectancies regarding the physical activity will be assessed with eight items according to Fuchs (1994).
Measured: At baseline, 6 months and in the follow-up after 12 months
Self-efficacy concerning physical activity participation (questionnaire)
Consistent with Fuchs (2008), self-efficacy will be assess by the confidence to begin, to maintain and to restart regular physical activity.
Measured: At baseline, 6 months and in the follow-up after 12 months
Barriers concerning physical activity participation (questionnaire)
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)
Measured: At baseline, 6 months and in the follow-up after 12 months
Social support for physical activity participation (questionnaire)
Social support will be assessed by 7 items that rate the confidence for support of the social environment (Fuchs, 1997).
Measured: At baseline, 6 months and in the follow-up after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xenia Fischer, University of Basel
- Investigators
- Lukas Zahner, Prof. Dr., Study director, Department of Sport, Exercise and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918578
- Sponsor's protocol ID
- 2016-00560
- Other IDs
- 2016
- Status last verified
- Jun 2019
- First submitted
- 23 Sep 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fischer X, Donath L, Zwygart K, Gerber M, Faude O, Zahner L. Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). Int J Environ Res Public Health. 2019 Jan 25;16(3):331. doi: 10.3390/ijerph16030331.
PubMed 30691013
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults
- ClinicalTrials.gov ID
- NCT02918578
- Acronym / sponsor ID
- 2016-00560
- Conditions
- Sedentary Lifestyle
- Keywords
- Physical Inactivity, Behavior Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare different modalities to communicate a remote and individually tailored physical activity promotion program.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Phone" group | Experimental | Other: "Phone" groupsee intervention description |
| "Phone and SMS" group | Experimental | Other: "Phone and SMS" groupsee intervention description |
| "single writing" group | Active comparator | Other: "single writing" groupsee intervention description |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- not meeting the physical activity guidelines of 150 minutes moderate or 75 minutes vigorous aerobic activity
Key exclusion criteria (1 listed)
- medical condition that contraindicates the participation in regular moderate-intensity exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Phone" groupParticipants 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. | Other | "Phone" group |
| "Phone and SMS" groupThe "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. | Other | "Phone and SMS" group |
| "single writing" groupThe 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. | Other | "single writing" group |
Primary outcome
Self-reported physical activity level of one week
Time frame: 6 months of intervention
Simple Physical Activity Questionnaire; SIMPAQ
Objectively assessed physical activity level of one week
Time frame: 6 months of intervention
Accelerometer
12 secondary outcomes
Self-reported physical activity level of one week
Time frame: In the follow-up after 12 months
Objectively assessed physical activity level of one week
Time frame: In the follow-up after 12 months
body weight
Time frame: 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
stress-related exhaustion symptoms (questionnaire)
Time frame: 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
Satisfaction with the program (questionnaire)
Time frame: 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
Outcome expectations on physical activity participation (questionnaire)
Time frame: 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
Barriers concerning physical activity participation (questionnaire)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 30691013Fischer X, Donath L, Zwygart K, Gerber M, Faude O, Zahner L. Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). Int J Environ Res Public Health. 2019 Jan 25;16(3):331. doi: 10.3390/ijerph16030331.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Zahner, Prof. Dr. study director
Department of Sport, Exercise and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Phone" group, "Phone and SMS" group and "single writing" group in people with Sedentary Lifestyle, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity level of one week (time frame: 6 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.