App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults
Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial
1 other identifier
interventional
209
1 country
1
Brief Summary
The aim of this study is to evaluate if modern technology such as smartphone applications can be used to facilitate lifestyle changes and thereby improve health-related quality of life in gainfully employed persons in the general population in Stockholm, Sweden. The hypothesis is that at follow-up, the intervention group that use the new application will have improved health-related quality of life and other lifestyle habits including diet, physical activity and sleep, as well as biomarkers, compared to a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2018
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedAugust 14, 2019
August 1, 2019
1.1 years
May 8, 2018
August 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Health related quality of life assessed by the RAND-36 questionnaire
Mental and Physical Health Scores (range 0-100) are assessed using 36 questions
12-weeks follow-up
Secondary Outcomes (10)
Physical activity
Baseline (week 0) and at 12-weeks follow-up
HbA1c (Heamoglobin A1c)
Baseline (week 0) and at 12-weeks follow-up
Total cholesterol
Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein A1
Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein B
Baseline (week 0) and at 12-weeks follow-up
- +5 more secondary outcomes
Other Outcomes (9)
Change in dietary habits
Baseline (week 0) and at 12-weeks follow-up
Change in eating behaviors according to the Three Factor Eating Questionnaire (TFEQ)
Baseline (week 0) and at 12-weeks follow-up
Change in tobacco use (user/non-user)
Baseline (week 0) and at 12-weeks follow-up
- +6 more other outcomes
Study Arms (3)
App technology and coaching
EXPERIMENTALParticipants in the intervention group with app technology and coaching participate in a first meeting with the coach and will thereafter receive active support from the coach every 4 weeks for the duration of the intervention.
App technology only
EXPERIMENTALParticipants in the intervention group with only app technology participate in a first meeting with the coach but do not get any additional support during follow-up.
Control group
NO INTERVENTIONParticipants in the control group participate in baseline assessments. The control group will get access to the app and will have a meeting with a coach after 12 weeks of follow-up.
Interventions
Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.
Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.
Eligibility Criteria
You may qualify if:
- years of age or older
- Ability to communicate in Swedish
- Have access to and use a smartphone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Research Institutes of Swedencollaborator
Study Sites (1)
Karolinska Institutet
Stockholm, Select One..., 17176, Sweden
Related Publications (3)
Bonn S, Licitra G, Bellocco R, Trolle Lagerros Y. Clinical Outcomes Among Working Adults Using the Health Integrator Smartphone App: Analyses of Prespecified Secondary Outcomes in a Randomized Controlled Trial. J Med Internet Res. 2022 Mar 21;24(3):e24725. doi: 10.2196/24725.
PMID: 35311677DERIVEDMelin J, Bonn SE, Pendrill L, Trolle Lagerros Y. A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory. JMIR Mhealth Uhealth. 2020 May 26;8(5):e15909. doi: 10.2196/15909.
PMID: 32452817DERIVEDBonn SE, Lof M, Ostenson CG, Trolle Lagerros Y. App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial. BMC Public Health. 2019 Mar 7;19(1):273. doi: 10.1186/s12889-019-6595-6.
PMID: 30845949DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Associate professor
Study Record Dates
First Submitted
May 8, 2018
First Posted
July 6, 2018
Study Start
April 16, 2018
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
August 14, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share