App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Lifestyle, Quality of Life, mHealth, Mobile Applications, Adults

Intervention / Treatment
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* Behavioral: App-technology and active coaching to improve lifestyles behaviors
* Behavioral: App-technology to improve lifestyle behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Ability to communicate in Swedish Have access to and use a smartphone Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App technology and coaching<br>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<br>* 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.<br>|
| Experimental: App technology only<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | 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) | mmol/mol | Baseline (week 0) and at 12-weeks follow-up | 
| Total cholesterol | (mmol/L) | Baseline (week 0) and at 12-weeks follow-up | 
| Apolipoprotein A1 | (g/l) | Baseline (week 0) and at 12-weeks follow-up | 
| Apolipoprotein B | (g/l) | Baseline (week 0) and at 12-weeks follow-up | 
| Body Mass Index | (kg/m2) | Baseline (week 0) and at 12-weeks follow-up | 
| Body weight | (kg) | Baseline (week 0) and at 12-weeks follow-up | 
| Waist circumference | (cm) | Baseline (week 0) and at 12-weeks follow-up | 
| Body composition | (%Body Fat) | Baseline (week 0) and at 12-weeks follow-up | 
| Blood pressure (Systolic and Diastolic) | (mmHg) | Baseline (week 0) and at 12-weeks follow-up |