LifestyleNCT03579342

App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

A study testing App-technology and active coaching to improve lifestyles behaviors and App-technology to improve lifestyle behaviors in people with Lifestyle and Quality of Life, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lifestyle, Quality of Life, mHealth
What is being tested?: App-technology and active coaching to improve lifestyles behaviors and App-technology to improve lifestyle behaviors
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 1 siteSweden
Study dates: 16 Apr 2018to 15 May 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years of age or older
Ability to communicate in Swedish
Have access to and use a smartphone

Who cannot join

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Institutet
Stockholm, Select One..., 17176

Other trials in Sweden

About this study

Official title: Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial

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.

Conditions: Lifestyle, Quality of Life, mHealth, Mobile Applications, Adults
Being tested: App-technology and active coaching to improve lifestyles behaviors, App-technology to improve lifestyle behaviors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

App-technology and active coaching to improve lifestyles behaviorsBehavioural
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.
App-technology to improve lifestyle behaviorsBehavioural
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.

Study groups in NCT03579342
Study group	Role	What they receive
App technology and coaching	Experimental	Participants 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. Receives: Behavioral: App-technology and active coaching to improve lifestyles behaviors
App technology only	Experimental	Participants 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. Receives: Behavioral: App-technology to improve lifestyle behaviors
Control group	No intervention	Participants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Health related quality of life assessed by the RAND-36 questionnaire
Mental and Physical Health Scores (range 0-100) are assessed using 36 questions
Measured: 12-weeks follow-up

Secondary outcomes (10)

Physical activity
Minutes per day spent on a sedentary, light, moderate or higher activity level assessed using accelerometers
Measured: Baseline (week 0) and at 12-weeks follow-up
HbA1c (Heamoglobin A1c)
mmol/mol
Measured: Baseline (week 0) and at 12-weeks follow-up
Total cholesterol
(mmol/L)
Measured: Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein A1
(g/l)
Measured: Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein B
(g/l)
Measured: Baseline (week 0) and at 12-weeks follow-up
Body Mass Index
(kg/m2)
Measured: Baseline (week 0) and at 12-weeks follow-up
Body weight
(kg)
Measured: Baseline (week 0) and at 12-weeks follow-up
Waist circumference
(cm)
Measured: Baseline (week 0) and at 12-weeks follow-up
Body composition
(%Body Fat)
Measured: Baseline (week 0) and at 12-weeks follow-up
Blood pressure (Systolic and Diastolic)
(mmHg)
Measured: Baseline (week 0) and at 12-weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 201815 May 2019

First posted6 Jul 2018
Study start16 Apr 2018
Primary completion15 May 2019
Study completion15 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for LifestyleStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03579342
Sponsor's protocol ID: 2018/411-31
Status last verified: Aug 2019
First submitted: 8 May 2018
Last updated: 14 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35311677
Melin 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.
PubMed 32452817
Bonn 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.
PubMed 30845949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03579342
Acronym / sponsor ID: 2018/411-31
Conditions: Lifestyle, Quality of Life, mHealth, Mobile Applications, Adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Research Institutes of Sweden
Study start: 16 Apr 2018 (actual)
Primary completion: 15 May 2019 (actual)
Study completion: 15 May 2019 (actual)
First posted: 6 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
App technology and coaching	Experimental	Behavioral: App-technology and active coaching to improve lifestyles behaviorsParticipants 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	Experimental	Behavioral: App-technology to improve lifestyle behaviorsParticipants 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 intervention	–Participants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years of age or older
Ability to communicate in Swedish
Have access to and use a smartphone

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
App-technology and active coaching to improve lifestyles behaviorsAccess 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.	Behavioural	App technology and coaching
App-technology to improve lifestyle behaviorsAccess 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.	Behavioural	App technology only

Primary outcome

Health related quality of life assessed by the RAND-36 questionnaire
Time frame: 12-weeks follow-up
Mental and Physical Health Scores (range 0-100) are assessed using 36 questions

10 secondary outcomes

Physical activity
Time frame: Baseline (week 0) and at 12-weeks follow-up
HbA1c (Heamoglobin A1c)
Time frame: Baseline (week 0) and at 12-weeks follow-up
Total cholesterol
Time frame: Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein A1
Time frame: Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein B
Time frame: Baseline (week 0) and at 12-weeks follow-up
Body Mass Index
Time frame: Baseline (week 0) and at 12-weeks follow-up
Body weight
Time frame: Baseline (week 0) and at 12-weeks follow-up
Waist circumference
Time frame: Baseline (week 0) and at 12-weeks follow-up
Body composition
Time frame: Baseline (week 0) and at 12-weeks follow-up
Blood pressure (Systolic and Diastolic)
Time frame: Baseline (week 0) and at 12-weeks follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Derived from this study: PubMed 35311677Bonn 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.
Derived from this study: PubMed 32452817Melin 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.
Derived from this study: PubMed 30845949Bonn 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life assessed by the RAND-36 questionnaire (time frame: 12-weeks follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579342, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.