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E-health Interventions to Promote Physical Activity Among Inactive Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526444
Acronym
ONWARDS
Enrollment
183
Registered
2020-08-25
Start date
2021-04-08
Completion date
2023-03-31
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity Promotion Among Inactive Adults

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.

Interventions

Fitness tracker Mi Smart Band 5 with the computational algorithm PAI

Les Mills On Demand

OTHERPeer support via social media

Facebook group

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Level of physical activity short-term6 monthsTime spent in moderate to vigorous physical activity
Level of physical activity medium-term12 monthsTime spent in moderate to vigorous physical activity
Level of physical activity long-term18 monthsTime spent in moderate to vigorous physical activity

Secondary

MeasureTime frameDescription
Body Mass Index (BMI) medium-term12 months
Body Mass Index (BMI) long-term18 months
Waist circumference short-term6 months
Waist circumference medium-term12 months
Waist circumference long-term18 months
Adherence to recommendation short-term6 monthsProportion of participants reaching the recommendation for physical activity
Adherence to recommendation medium-term12 monthsProportion of participants reaching the recommendation for physical activity
Adherence to recommendation long-term18 monthsProportion of participants reaching the recommendation for physical activity
Physical fitness short-term6 monthsVO2 max (estimated)
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term6 monthsEQ-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).
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term12 monthsEQ-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).
EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term18 monthsEQ-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).
Perceived competence for exercise (PCS-EX) short-term6 months4 items. Min 4, max 28 (28 high competence)
Physical fitness medium-term12 monthsVO2 max (estimated)
Perceived competence for exercise (PCS-EX) long-term18 months4 items. Min 4, max 28 (28 high competence)
Self-efficacy for exercise (SEE) Scale short-term6 monthsScale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Self-efficacy for exercise (SEE) Scale medium-term12 monthsScale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Self-efficacy for exercise (SEE) Scale long-term18 monthsScale with 9 items, min 0 and max 90. Higher score indicates higher self-efficacy for exercise.
Social Support (SSES) short-term6 months13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Social Support (SSES) medium-term12 months13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Social Support and Exercise scale (SSES) long-term18 months13 items answered two times, one for family and one for friends. Min 13, max 65 (65 highest level of social support)
Reasons for performing physical activity short-term6 monthsBehavioural Regulation Exercise Questionnaire (BREQ-2).
Reasons for performing physical activity medium-term12 monthsBehavioural Regulation Exercise Questionnaire (BREQ-2).
Reasons for performing physical activity long-term18 monthsBehavioural Regulation Exercise Questionnaire (BREQ-2).
System Usability Scale (SUS)6 months10 items, min 0 max 100 (above 68 is above the average).
Users' perspectives on intervention through interviews short-term6 monthsQualitative data derived from semi-structured interviews with participants.
Users' perspectives on intervention through interviews long-term18 monthsQualitative data derived from semi-structured interviews with participants.
Perceived competence for exercise (PCS-EX) medium-term12 months4 items. Min 4, max 28 (28 high competence)
Physical fitness long-term18 monthsVO2 max (estimated)
Body Mass Index (BMI) short-term6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026