Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- Health related quality of life assessed by the RAND-36 questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years of age or older
- •Ability to communicate in Swedish
- •Have access to and use a smartphone
Exclusion Criteria
- Not provided
Arms & Interventions
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.
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.
Intervention: App-technology to improve lifestyle behaviors (Behavioral)
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.
Intervention: App-technology and active coaching to improve lifestyles behaviors (Behavioral)
Outcomes
Primary Outcomes
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
- 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)
- Body Mass Index(Baseline (week 0) and at 12-weeks follow-up)
- Body weight(Baseline (week 0) and at 12-weeks follow-up)
- Waist circumference(Baseline (week 0) and at 12-weeks follow-up)
- Body composition(Baseline (week 0) and at 12-weeks follow-up)
- Blood pressure (Systolic and Diastolic)(Baseline (week 0) and at 12-weeks follow-up)
Investigators
Ylva Trolle Lagerros
MD, Associate professor
Karolinska Institutet