App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053336
• Other study ID #: Dnr: 2016/2041-31/2
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a diagnosis of type 2 diabetes

• 18 years of age or older

• Ability to communicate in Swedish

• Have and be able to use a smartphone

Exclusion Criteria:

• Not being able to walk

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• App-technology to increase physical activity
Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in dietary habits assessed using a food frequency questionnaire		Baseline and month 3, 6 and 12
Other	Change in tobacco use habits (smoking and Swedish snuff use)		Baseline and month 3, 6 and 12
Other	Change in sleeping habits assessed using a 13 item questionnaire		Baseline and month 3, 6 and 12
Other	Change in perceived purpose in life		Baseline and month 3, 6 and 12
Other	Change in perceived stress levels using the perceived stress scale		Baseline and month 3, 6 and 12
Other	Change in reported self-efficacy for exercise	One's confidence in walking is assessed	Baseline and month 3, 6 and 12
Other	Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire		Baseline and month 3, 6 and 12
Other	Change in RAND-36		Baseline and month 3, 6 and 12
Other	Change in neighborhood Environment assessed by questions on safety and walking environment		Baseline and month 3, 6 and 12
Other	Social support for exercise assessed using a 6 item questionnaire		Baseline and month 3, 6 and 12
Primary	Change in physical activity level (counts/min from accelerometers)		baseline and month 3, 6 and 12
Secondary	HbA1c (mmol/mol)		Baseline and month 3, 6 and 12
Secondary	Steps/day		Baseline and month 3, 6 and 12
Secondary	Total cholesterol (mmol/L)		Baseline and month 3, 6 and 12
Secondary	HDL-cholesterol (mmol/L)		Baseline and month 3, 6 and 12
Secondary	Triglycerides (mmol/L)		Baseline and month 3, 6 and 12
Secondary	Apolipoprotein A1 (g/l)		Baseline and month 3, 6 and 12
Secondary	Apolipoprotein B (g/l)		Baseline and month 3, 6 and 12
Secondary	Body weight (kg)		Baseline and month 3, 6 and 12
Secondary	Body Mass Index (BMI, kg/m2)		Baseline and month 3, 6 and 12
Secondary	Body composition	Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)	Baseline and month 3, 6 and 12
Secondary	Waist circumference (cm)		Baseline and month 3, 6 and 12
Secondary	Blood pressure (mmHg)		Baseline and month 3, 6 and 12