E-health Interventions to Promote Physical Activity Among Inactive Adults

Physical Activity Promotion Among Inactive Adults Clinical Trial

— ONWARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526444
• Other study ID #: 66573
• Status: Completed
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Physical Activity Promotion Among Inactive Adults

Intervention

Device:
• Fitness tracker
Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Other:
• Online training
Les Mills On Demand
• Peer support via social media
Facebook group

Locations

Country	Name	City	State
Norway	Norwegian Centre for E-health Research	Tromsø

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital of North Norway	Frisklivssentralen, Laval University, Les Mills International, Norwegian University of Science and Technology, PAI Health Norway AS, SINTEF Health Research, St. Olavs Hospital, UiT The Arctic University of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of physical activity short-term	Time spent in moderate to vigorous physical activity	6 months
Primary	Level of physical activity medium-term	Time spent in moderate to vigorous physical activity	12 months
Primary	Level of physical activity long-term	Time spent in moderate to vigorous physical activity	18 months
Secondary	Adherence to recommendation short-term	Proportion of participants reaching the recommendation for physical activity	6 months
Secondary	Adherence to recommendation medium-term	Proportion of participants reaching the recommendation for physical activity	12 months
Secondary	Adherence to recommendation long-term	Proportion of participants reaching the recommendation for physical activity	18 months
Secondary	Physical fitness short-term	VO2 max (estimated)	6 months
Secondary	Physical fitness medium-term	VO2 max (estimated)	12 months
Secondary	Physical fitness long-term	VO2 max (estimated)	18 months
Secondary	Body Mass Index (BMI) short-term		6 months
Secondary	Body Mass Index (BMI) medium-term		12 months
Secondary	Body Mass Index (BMI) long-term		18 months
Secondary	Waist circumference short-term		6 months
Secondary	Waist circumference medium-term		12 months
Secondary	Waist circumference long-term		18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Perceived competence for exercise (PCS-EX) short-term	4 items. Min 4, max 28 (28 high competence)	6 months
Secondary	Perceived competence for exercise (PCS-EX) medium-term	4 items. Min 4, max 28 (28 high competence)	12 months
Secondary	Perceived competence for exercise (PCS-EX) long-term	4 items. Min 4, max 28 (28 high competence)	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reasons for performing physical activity short-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	6 months
Secondary	Reasons for performing physical activity medium-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	12 months
Secondary	Reasons for performing physical activity long-term	Behavioural Regulation Exercise Questionnaire (BREQ-2).	18 months
Secondary	System Usability Scale (SUS)	10 items, min 0 max 100 (above 68 is above the average).	6 months
Secondary	Users' perspectives on intervention through interviews short-term	Qualitative data derived from semi-structured interviews with participants.	6 months
Secondary	Users' perspectives on intervention through interviews long-term	Qualitative data derived from semi-structured interviews with participants.	18 months