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Completed

NCT Number: NCT03579342

App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Select One..., 17176, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

App-technology and active coaching to improve lifestyles behaviors

Behavioral

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 behaviors

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. HbA1c (Heamoglobin A1c)

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    mmol/mol

  3. Total cholesterol

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (mmol/L)

  4. Apolipoprotein A1

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (g/l)

  5. Apolipoprotein B

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (g/l)

  6. Body Mass Index

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (kg/m2)

  7. Body weight

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (kg)

  8. Waist circumference

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (cm)

  9. Body composition

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (%Body Fat)

  10. Blood pressure (Systolic and Diastolic)

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    (mmHg)

Other outcomes

  1. 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

  2. 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

  3. Change in tobacco use (user/non-user)

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    Smoking and Swedish snuff use

  4. Change in sleeping habits

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    Assessed using a modified 13-item Karolinska Sleep questionnaire

  5. Change in perceived Purpose In Life (PIL)

    Time frame: Baseline (week 0) and at 12-weeks follow-up

    6-item questionnaire

  6. 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)

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Research Institutes of Sweden

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2018
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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