App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

• ClinicalTrials.gov Identifier: NCT03579342
• Recruitment Status: Completed
• First Posted: July 6, 2018
• Last Update Posted: August 14, 2019
• Sponsor: Karolinska Institutet
• Collaborator: Research Institutes of Sweden (RISE)
• Information provided by (Responsible Party): Ylva Trolle Lagerros, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lifestyle; Quality of Life; mHealth; Mobile Applications; Adults	Behavioral: App-technology and active coaching to improve lifestyles behaviors; Behavioral: App-technology to improve lifestyle behaviors	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 209 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial
• Actual Study Start Date: April 16, 2018
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: May 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Locations

Sweden

Karolinska Institutet

Stockholm, Select One..., Sweden, 17176

Sponsors and Collaborators

Karolinska Institutet

Research Institutes of Sweden (RISE)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Löf M, Östenson 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.

• Responsible Party: Ylva Trolle Lagerros, MD, Associate professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03579342
• Other Study ID Numbers: 2018/411-31
• First Posted: July 6, 2018
• Last Update Posted: August 14, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No