Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults

Sedentary Lifestyle Clinical Trial

Official title:

Tailored Multicomponent Intervention for Remote Physical Activity Promotion in Inactive Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918578
• Other study ID #: 2016-00560
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2019
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Other:
• "Phone" group
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
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
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.

Locations

Country	Name	City	State
Switzerland	University of Basel, Department of Sport, Exercise and Health	Basel	Birsstr. 320B

Sponsors (1)

Lead Sponsor	Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported physical activity level of one week	Simple Physical Activity Questionnaire; SIMPAQ	6 months of intervention
Primary	Objectively assessed physical activity level of one week	Accelerometer	6 months of intervention
Secondary	Self-reported physical activity level of one week	Simple Physical Activity Questionnaire; SIMPAQ	In the follow-up after 12 months
Secondary	Objectively assessed physical activity level of one week	Accelerometer	In the follow-up after 12 months
Secondary	body weight		At baseline, 6 months and in the follow-up after 12 months
Secondary	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.	At baseline, 6 months and in the follow-up after 12 months
Secondary	stress-related exhaustion symptoms (questionnaire)	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
Secondary	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.	At baseline, 6 months and in the follow-up after 12 months
Secondary	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.	At baseline, 6 months and in the follow-up after 12 months
Secondary	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).	At baseline, 6 months and in the follow-up after 12 months
Secondary	Outcome expectations on physical activity participation (questionnaire)	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
Secondary	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.	At baseline, 6 months and in the follow-up after 12 months
Secondary	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)	At baseline, 6 months and in the follow-up after 12 months
Secondary	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).	At baseline, 6 months and in the follow-up after 12 months