App-technology to Improve Healthy Lifestyle Behaviors Among Working Adults

Quality of Life Clinical Trial

Official title:

Using App-technology and a Personalized Health Plan to Improve Lifestyle Habits Among Working Adults - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579342
• Other study ID #: 2018/411-31
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: August 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Ability to communicate in Swedish

• Have access to and use a smartphone

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Adults
• Lifestyle
• mHealth
• Mobile Applications
• Quality of Life

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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Select One...

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Research Institutes of Sweden (RISE)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in tobacco use (user/non-user)	Smoking and Swedish snuff use	Baseline (week 0) and at 12-weeks follow-up
Other	Change in sleeping habits	Assessed using a modified 13-item Karolinska Sleep questionnaire	Baseline (week 0) and at 12-weeks follow-up
Other	Change in perceived Purpose In Life (PIL)	6-item questionnaire	Baseline (week 0) and at 12-weeks follow-up
Other	Change in perceived stress levels	Assessed using the 14-item perceived stress scale (PSS)	Baseline (week 0) and at 12-weeks follow-up
Other	Change in motivation to make lifestyle changes	Assessed using Prochaskas' transtheoretical model of behavior change	Baseline (week 0) and at 12-weeks follow-up
Other	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)
Other	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
Primary	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	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
Secondary	HbA1c (Heamoglobin A1c)	mmol/mol	Baseline (week 0) and at 12-weeks follow-up
Secondary	Total cholesterol	(mmol/L)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Apolipoprotein A1	(g/l)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Apolipoprotein B	(g/l)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Body Mass Index	(kg/m2)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Body weight	(kg)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Waist circumference	(cm)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Body composition	(%Body Fat)	Baseline (week 0) and at 12-weeks follow-up
Secondary	Blood pressure (Systolic and Diastolic)	(mmHg)	Baseline (week 0) and at 12-weeks follow-up