Clinical trial NCT03579342: App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults
Official title: Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle
Quality of Life
mHealth
Mobile Applications
Adults
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Research Institutes of Sweden
First posted: 2018-07-06
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Health related quality of life assessed by the RAND-36 questionnaire
timeFrame: 12-weeks follow-up
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: HbA1c (Heamoglobin A1c)
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Total cholesterol
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Apolipoprotein A1
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Apolipoprotein B
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Body Mass Index
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Body weight
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Waist circumference
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Body composition
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Blood pressure (Systolic and Diastolic)
timeFrame: Baseline (week 0) and at 12-weeks follow-up
Other outcomes:
measure: Change in dietary habits
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in eating behaviors according to the Three Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in tobacco use (user/non-user)
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in sleeping habits
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in perceived Purpose In Life (PIL)
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in perceived stress levels
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Change in motivation to make lifestyle changes
timeFrame: Baseline (week 0) and at 12-weeks follow-up
measure: Social support for an overall healthy lifestyle
timeFrame: Baseline (week 0)
measure: Change in self-reported sitting time and physical activity
timeFrame: Baseline (week 0) and at 12-weeks follow-up
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Select One...
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.