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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Exercise
• Interventions: Behavioral: App-technology to increase physical activity

• Registration Number: NCT03053336
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-15
• Study Start: 2017-02-21
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

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Exclusion Criteria

• Not being able to walk

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App-technology group	App-technology to increase physical activity	Participants in the intervention group (App-technology) will use a newly developed smartphone application ("app") in which steps are automatically measured and laboratory values from blood sampling within primary care will be shown. Intervention: App-technology to increase physical activity

Primary Outcome Measures

Name	Time	Method
Change in physical activity level (counts/min from accelerometers)	baseline and month 3, 6 and 12

Secondary Outcome Measures

Name	Time	Method
Total cholesterol (mmol/L)	Baseline and month 3, 6 and 12
Steps/day	Baseline and month 3, 6 and 12
HbA1c (mmol/mol)	Baseline and month 3, 6 and 12
Triglycerides (mmol/L)	Baseline and month 3, 6 and 12
HDL-cholesterol (mmol/L)	Baseline and month 3, 6 and 12
Apolipoprotein A1 (g/l)	Baseline and month 3, 6 and 12
Apolipoprotein B (g/l)	Baseline and month 3, 6 and 12
Body weight (kg)	Baseline and month 3, 6 and 12
Body Mass Index (BMI, kg/m2)	Baseline and month 3, 6 and 12
Body composition	Baseline and month 3, 6 and 12	Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)
Waist circumference (cm)	Baseline and month 3, 6 and 12
Blood pressure (mmHg)	Baseline and month 3, 6 and 12

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden