Clinical trial NCT04526444: E-health Interventions to Promote Physical Activity Among Inactive Adults
Official title: E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity Promotion Among Inactive Adults
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: UiT The Arctic University of Norway
name: SINTEF Health Research
name: PAI Health Norway AS
name: St. Olavs Hospital
name: Norwegian University of Science and Technology
name: Frisklivssentralen
name: Laval University
name: Les Mills International
First posted: 2020-08-25
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Level of physical activity short-term
timeFrame: 6 months
measure: Level of physical activity medium-term
timeFrame: 12 months
measure: Level of physical activity long-term
timeFrame: 18 months
Secondary outcomes:
measure: Adherence to recommendation short-term
timeFrame: 6 months
measure: Adherence to recommendation medium-term
timeFrame: 12 months
measure: Adherence to recommendation long-term
timeFrame: 18 months
measure: Physical fitness short-term
timeFrame: 6 months
measure: Physical fitness medium-term
timeFrame: 12 months
measure: Physical fitness long-term
timeFrame: 18 months
measure: Body Mass Index (BMI) short-term
timeFrame: 6 months
measure: Body Mass Index (BMI) medium-term
timeFrame: 12 months
measure: Body Mass Index (BMI) long-term
timeFrame: 18 months
measure: Waist circumference short-term
timeFrame: 6 months
measure: Waist circumference medium-term
timeFrame: 12 months
measure: Waist circumference long-term
timeFrame: 18 months
measure: EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term
timeFrame: 6 months
measure: EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term
timeFrame: 12 months
measure: EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term
timeFrame: 18 months
measure: Perceived competence for exercise (PCS-EX) short-term
timeFrame: 6 months
measure: Perceived competence for exercise (PCS-EX) medium-term
timeFrame: 12 months
measure: Perceived competence for exercise (PCS-EX) long-term
timeFrame: 18 months
measure: Self-efficacy for exercise (SEE) Scale short-term
timeFrame: 6 months
measure: Self-efficacy for exercise (SEE) Scale medium-term
timeFrame: 12 months
measure: Self-efficacy for exercise (SEE) Scale long-term
timeFrame: 18 months
measure: Social Support (SSES) short-term
timeFrame: 6 months
measure: Social Support (SSES) medium-term
timeFrame: 12 months
measure: Social Support and Exercise scale (SSES) long-term
timeFrame: 18 months
measure: Reasons for performing physical activity short-term
timeFrame: 6 months
measure: Reasons for performing physical activity medium-term
timeFrame: 12 months
measure: Reasons for performing physical activity long-term
timeFrame: 18 months
measure: System Usability Scale (SUS)
timeFrame: 6 months
measure: Users' perspectives on intervention through interviews short-term
timeFrame: 6 months
measure: Users' perspectives on intervention through interviews long-term
timeFrame: 18 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Norwegian Centre for E-health Research
Study officials:
References:
citation: 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.