App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

August 13, 2019 updated by: Ylva Trolle Lagerros, Karolinska Institutet

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Select One...
      • Stockholm, Select One..., Sweden, 17176
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: App technology and coaching
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.
Behavioral: App-technology and active coaching to improve lifestyles behaviors
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.
Experimental: App technology only
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.
Behavioral: App-technology to improve lifestyle behaviors
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.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12-weeks follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Minutes per day spent on a sedentary, light, moderate or higher activity level assessed using accelerometers
Baseline (week 0) and at 12-weeks follow-up
HbA1c (Heamoglobin A1c)
Time Frame: Baseline (week 0) and at 12-weeks follow-up
mmol/mol
Baseline (week 0) and at 12-weeks follow-up
Total cholesterol
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(mmol/L)
Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein A1
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(g/l)
Baseline (week 0) and at 12-weeks follow-up
Apolipoprotein B
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(g/l)
Baseline (week 0) and at 12-weeks follow-up
Body Mass Index
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(kg/m2)
Baseline (week 0) and at 12-weeks follow-up
Body weight
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(kg)
Baseline (week 0) and at 12-weeks follow-up
Waist circumference
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(cm)
Baseline (week 0) and at 12-weeks follow-up
Body composition
Time Frame: Baseline (week 0) and at 12-weeks follow-up
(%Body Fat)
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
(mmHg)
Baseline (week 0) and at 12-weeks follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dietary habits
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Intake of macro- and Micro nutrients are assessed based on responses to a food frequency questionnaire
Baseline (week 0) and at 12-weeks follow-up
Change in eating behaviors according to the Three Factor Eating Questionnaire (TFEQ)
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Emotional eating, uncontrolled eating, and cognitive restricted eating are assessed using a 21-item questionnaire
Baseline (week 0) and at 12-weeks follow-up
Change in tobacco use (user/non-user)
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Smoking and Swedish snuff use
Baseline (week 0) and at 12-weeks follow-up
Change in sleeping habits
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Assessed using a modified 13-item Karolinska Sleep questionnaire
Baseline (week 0) and at 12-weeks follow-up
Change in perceived Purpose In Life (PIL)
Time Frame: Baseline (week 0) and at 12-weeks follow-up
6-item questionnaire
Baseline (week 0) and at 12-weeks follow-up
Change in perceived stress levels
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Assessed using the 14-item perceived stress scale (PSS)
Baseline (week 0) and at 12-weeks follow-up
Change in motivation to make lifestyle changes
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Assessed using Prochaskas' transtheoretical model of behavior change
Baseline (week 0) and at 12-weeks follow-up
Social support for an overall healthy lifestyle
Time Frame: Baseline (week 0)
Social support for maintenance of a healthy Lifestyle from family, friends and co-workers is assessed by a 5-item questionnaire
Baseline (week 0)
Change in self-reported sitting time and physical activity
Time Frame: Baseline (week 0) and at 12-weeks follow-up
Assessed by 6 questions on sitting time and exercise
Baseline (week 0) and at 12-weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Institutes of Sweden (RISE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/411-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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