App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT03579342
• Collaborator: Research Institutes of Sweden (RISE) (Other)
• Enrollment: 209
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 16.1

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 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 [12-weeks follow-up]

   Mental and Physical Health Scores (range 0-100) are assessed using 36 questions

Secondary Outcome Measures

1. Physical activity [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) [Baseline (week 0) and at 12-weeks follow-up]

   mmol/mol

3. Total cholesterol [Baseline (week 0) and at 12-weeks follow-up]

   (mmol/L)

4. Apolipoprotein A1 [Baseline (week 0) and at 12-weeks follow-up]

   (g/l)

5. Apolipoprotein B [Baseline (week 0) and at 12-weeks follow-up]

   (g/l)

6. Body Mass Index [Baseline (week 0) and at 12-weeks follow-up]

   (kg/m2)

7. Body weight [Baseline (week 0) and at 12-weeks follow-up]

   (kg)

8. Waist circumference [Baseline (week 0) and at 12-weeks follow-up]

   (cm)

9. Body composition [Baseline (week 0) and at 12-weeks follow-up]

   (%Body Fat)

10. Blood pressure (Systolic and Diastolic) [Baseline (week 0) and at 12-weeks follow-up]

    (mmHg)

Other Outcome Measures

1. Change in dietary habits [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) [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) [Baseline (week 0) and at 12-weeks follow-up]

   Smoking and Swedish snuff use

4. Change in sleeping habits [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) [Baseline (week 0) and at 12-weeks follow-up]

   6-item questionnaire

6. Change in perceived stress levels [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 [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 [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 [Baseline (week 0) and at 12-weeks follow-up]

   Assessed by 6 questions on sitting time and exercise

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm	Select One...	Sweden	17176

Sponsors and Collaborators

• Karolinska Institutet
• Research Institutes of Sweden (RISE)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ylva Trolle Lagerros, MD, Associate professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03579342
• Other Study ID Numbers: 2018/411-31
• First Posted: Jul 6, 2018
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 14, 2019