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

Primary Purpose

Type 2 Diabetes Mellitus, Exercise

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
App-technology to increase physical activity
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App-technology group

Control group

Arm Description

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

The control group will receive standard care

Outcomes

Primary Outcome Measures

Change in physical activity level (counts/min from accelerometers)

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2017
Last Updated
September 28, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT03053336
Brief Title
App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes
Official Title
App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App-technology group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
App-technology to increase physical activity
Intervention Description
Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.
Primary Outcome Measure Information:
Title
Change in physical activity level (counts/min from accelerometers)
Time Frame
baseline and month 3, 6 and 12
Secondary Outcome Measure Information:
Title
HbA1c (mmol/mol)
Time Frame
Baseline and month 3, 6 and 12
Title
Steps/day
Time Frame
Baseline and month 3, 6 and 12
Title
Total cholesterol (mmol/L)
Time Frame
Baseline and month 3, 6 and 12
Title
HDL-cholesterol (mmol/L)
Time Frame
Baseline and month 3, 6 and 12
Title
Triglycerides (mmol/L)
Time Frame
Baseline and month 3, 6 and 12
Title
Apolipoprotein A1 (g/l)
Time Frame
Baseline and month 3, 6 and 12
Title
Apolipoprotein B (g/l)
Time Frame
Baseline and month 3, 6 and 12
Title
Body weight (kg)
Time Frame
Baseline and month 3, 6 and 12
Title
Body Mass Index (BMI, kg/m2)
Time Frame
Baseline and month 3, 6 and 12
Title
Body composition
Description
Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)
Time Frame
Baseline and month 3, 6 and 12
Title
Waist circumference (cm)
Time Frame
Baseline and month 3, 6 and 12
Title
Blood pressure (mmHg)
Time Frame
Baseline and month 3, 6 and 12
Other Pre-specified Outcome Measures:
Title
Change in dietary habits assessed using a food frequency questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in tobacco use habits (smoking and Swedish snuff use)
Time Frame
Baseline and month 3, 6 and 12
Title
Change in sleeping habits assessed using a 13 item questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in perceived purpose in life
Time Frame
Baseline and month 3, 6 and 12
Title
Change in perceived stress levels using the perceived stress scale
Time Frame
Baseline and month 3, 6 and 12
Title
Change in reported self-efficacy for exercise
Description
One's confidence in walking is assessed
Time Frame
Baseline and month 3, 6 and 12
Title
Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire
Time Frame
Baseline and month 3, 6 and 12
Title
Change in RAND-36
Time Frame
Baseline and month 3, 6 and 12
Title
Change in neighborhood Environment assessed by questions on safety and walking environment
Time Frame
Baseline and month 3, 6 and 12
Title
Social support for exercise assessed using a 6 item questionnaire
Time Frame
Baseline and month 3, 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ylva Trolle Lagerros, MD, PhD
Organizational Affiliation
Karolinska Institutet and Stockholm County Councill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29316905
Citation
Bonn SE, Alexandrou C, Hjorleifsdottir Steiner K, Wiklander K, Ostenson CG, Lof M, Trolle Lagerros Y. App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):119. doi: 10.1186/s12889-018-5026-4.
Results Reference
derived

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

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