App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

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: Completed
• Conditions: Quality of Life; mHealth; Mobile Applications; Lifestyle; Adults
• Intervention / Treatment: Behavioral: App-technology and active coaching to improve lifestyles behaviors; Behavioral: App-technology to improve lifestyle behaviors

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary habits	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)	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)	Smoking and Swedish snuff use	Baseline (week 0) and at 12-weeks follow-up
Change in sleeping habits	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)	6-item questionnaire	Baseline (week 0) and at 12-weeks follow-up
Change in perceived stress levels	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	Assessed using Prochaskas' transtheoretical model of behavior change	Baseline (week 0) and at 12-weeks follow-up
Social support for an overall healthy lifestyle	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	Assessed by 6 questions on sitting time and exercise	Baseline (week 0) and at 12-weeks follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Research Institutes of Sweden (RISE)

Publications and helpful links

General Publications

• 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. Erratum In: J Med Internet Res. 2022 Mar 24;24(3):e38199.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID 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