E-health Interventions to Promote Physical Activity Among Inactive Adults (ONWARDS)

E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial

The project addresses physical inactivity as a global health issue. Physical inactivity is the fourth leading risk factor for global mortality. Moreover, inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy in the use of certain strategies including fitness technologies and digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness of PA promotion strategies.

A Hybrid Type I effectiveness-implementation randomised controlled trial (RCT) will investigate the effects of 1) fitness trackers, 2) home-based online training, and 3) peer support via social media among inactive adults. The design will allow testing the study outcomes while gathering information on implementation in a real-world situation. The study will produce evidence on whether these interventions increase the levels of PA among inactive adults and improve health outcomes. Increased PA will also result in better primary prevention of lifestyle diseases.

Study Overview

• Status: Completed
• Conditions: Physical Activity Promotion Among Inactive Adults
• Intervention / Treatment: Device: Fitness tracker; Other: Online training; Other: Peer support via social media

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway
    • Norwegian Centre for E-health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• young (18-40 years) or middle aged (40-55 years) healthy adults, both men and women;
• inactive (undertaking less than 150 min of moderate-intensity PA per week) in the last 3 months;
• living in the Troms and Finnmark county;
• current owner of a smartphone;
• able to understand training instructions in English language.

Exclusion Criteria:

• presence of disabilities which might reduce the ability to perform exercise;
• presence of conditions which might prevent from safely exercise;
• lack of Internet connection at home;
• lack of space to exercise safely at home (recommended 4 sqm).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ftiness tracker; Participants in the group A will be provided the fitness tracker Mi Smart Band 5 with the computational algorithm PAI.	Device: Fitness tracker; Fitness tracker Mi Smart Band 5 with the computational algorithm PAI
Experimental: Home training platform and fitness tracker; Participants in group B will be provided with both the fitness tracker Mi Smart Band 5 with the computational algorithm PAI and access to Les Mills On Demand to perform training classes from home.	Device: Fitness tracker; Fitness tracker Mi Smart Band 5 with the computational algorithm PAI; Other: Online training; Les Mills On Demand
Experimental: Peer support, home training platform and fitness tracker and; Participants in group C will be offered the fitness tracker Mi Smart Band 5 with the computational algorithm PAI, Les Mills On Demand and additional peer support via social media.	Device: Fitness tracker; Fitness tracker Mi Smart Band 5 with the computational algorithm PAI; Other: Online training; Les Mills On Demand; Other: Peer support via social media; Facebook group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of physical activity short-term	Time spent in moderate to vigorous physical activity	6 months
Level of physical activity medium-term	Time spent in moderate to vigorous physical activity	12 months
Level of physical activity long-term	Time spent in moderate to vigorous physical activity	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to recommendation short-term	Proportion of participants reaching the recommendation for physical activity	6 months
Adherence to recommendation medium-term	Proportion of participants reaching the recommendation for physical activity	12 months
Adherence to recommendation long-term	Proportion of participants reaching the recommendation for physical activity	18 months
Physical fitness short-term	VO2 max (estimated)	6 months
Physical fitness medium-term	VO2 max (estimated)	12 months
Physical fitness long-term	VO2 max (estimated)	18 months
Body Mass Index (BMI) short-term		6 months
Body Mass Index (BMI) medium-term		12 months
Body Mass Index (BMI) long-term		18 months
Waist circumference short-term		6 months
Waist circumference medium-term		12 months
Waist circumference long-term		18 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term	EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).	6 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term	EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).	12 months
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term	EQ-5D-5L has 5 dimensions and 5 levels from 1 to 5 in each dimension (1 is no problems). It also includes a Visual Analogue scale from 0 to 100 (100 is best possible health). Rating can be transformed to a score with min -0.654 and max (1 is no problems in all dimensions).	18 months
Perceived competence for exercise (PCS-EX) short-term	4 items. Min 4, max 28 (28 high competence)	6 months
Perceived competence for exercise (PCS-EX) medium-term	4 items. Min 4, max 28 (28 high competence)	12 months
Perceived competence for exercise (PCS-EX) long-term	4 items. Min 4, max 28 (28 high competence)	18 months
Self-efficacy for exercise (SEE) Scale short-term	Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.	6 months
Self-efficacy for exercise (SEE) Scale medium-term	Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.	12 months
Self-efficacy for exercise (SEE) Scale long-term	Scale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.	18 months
Social Support (SSES) short-term	13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)	6 months
Social Support (SSES) medium-term	13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)	12 months
Social Support and Exercise scale (SSES) long-term	13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)	18 months
Reasons for performing physical activity short-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	6 months
Reasons for performing physical activity medium-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	12 months
Reasons for performing physical activity long-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	18 months
System Usability Scale (SUS)	10 items, min 0 max 100 (above 68 is above the average).	6 months
Users' perspectives on intervention through interviews short-term	Qualitative data derived from semi-structured interviews with participants.	6 months
Users' perspectives on intervention through interviews long-term	Qualitative data derived from semi-structured interviews with participants.	18 months

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Norwegian University of Science and Technology; St. Olavs Hospital; Laval University; SINTEF Health Research; UiT The Arctic University of Norway; PAI Health Norway AS; Frisklivssentralen; Les Mills International

Publications and helpful links

General Publications

• Zanaboni P, Manskow US, Sagelv EH, Morseth B, Edvardsen AE, Aamot IL, Nes BM, Hastings B, Gagnon MP, Antypas K. Digital interventions to promote physical activity among inactive adults: A study protocol for a hybrid type I effectiveness-implementation randomized controlled trial. Front Public Health. 2022 Oct 21;10:925484. doi: 10.3389/fpubh.2022.925484. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 66573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No