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

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ClinicalTrials.gov Identifier: NCT03053336
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Ylva Trolle Lagerros, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Exercise Behavioral: App-technology to increase physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App-technology group

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

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.

No Intervention: Control group
The control group will receive standard care



Primary Outcome Measures :
  1. Change in physical activity level (counts/min from accelerometers) [ Time Frame: baseline and month 3, 6 and 12 ]

Secondary Outcome Measures :
  1. HbA1c (mmol/mol) [ Time Frame: Baseline and month 3, 6 and 12 ]
  2. Steps/day [ Time Frame: Baseline and month 3, 6 and 12 ]
  3. Total cholesterol (mmol/L) [ Time Frame: Baseline and month 3, 6 and 12 ]
  4. HDL-cholesterol (mmol/L) [ Time Frame: Baseline and month 3, 6 and 12 ]
  5. Triglycerides (mmol/L) [ Time Frame: Baseline and month 3, 6 and 12 ]
  6. Apolipoprotein A1 (g/l) [ Time Frame: Baseline and month 3, 6 and 12 ]
  7. Apolipoprotein B (g/l) [ Time Frame: Baseline and month 3, 6 and 12 ]
  8. Body weight (kg) [ Time Frame: Baseline and month 3, 6 and 12 ]
  9. Body Mass Index (BMI, kg/m2) [ Time Frame: Baseline and month 3, 6 and 12 ]
  10. Body composition [ Time Frame: Baseline and month 3, 6 and 12 ]
    Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %)

  11. Waist circumference (cm) [ Time Frame: Baseline and month 3, 6 and 12 ]
  12. Blood pressure (mmHg) [ Time Frame: Baseline and month 3, 6 and 12 ]

Other Outcome Measures:
  1. Change in dietary habits assessed using a food frequency questionnaire [ Time Frame: Baseline and month 3, 6 and 12 ]
  2. Change in tobacco use habits (smoking and Swedish snuff use) [ Time Frame: Baseline and month 3, 6 and 12 ]
  3. Change in sleeping habits assessed using a 13 item questionnaire [ Time Frame: Baseline and month 3, 6 and 12 ]
  4. Change in perceived purpose in life [ Time Frame: Baseline and month 3, 6 and 12 ]
  5. Change in perceived stress levels using the perceived stress scale [ Time Frame: Baseline and month 3, 6 and 12 ]
  6. Change in reported self-efficacy for exercise [ Time Frame: Baseline and month 3, 6 and 12 ]
    One's confidence in walking is assessed

  7. Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire [ Time Frame: Baseline and month 3, 6 and 12 ]
  8. Change in RAND-36 [ Time Frame: Baseline and month 3, 6 and 12 ]
  9. Change in neighborhood Environment assessed by questions on safety and walking environment [ Time Frame: Baseline and month 3, 6 and 12 ]
  10. Social support for exercise assessed using a 6 item questionnaire [ Time Frame: Baseline and month 3, 6 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053336


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
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Principal Investigator: Ylva Trolle Lagerros, MD, PhD Karolinska Institutet and Stockholm County Councill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ylva Trolle Lagerros, MD, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03053336     History of Changes
Other Study ID Numbers: Dnr: 2016/2041-31/2
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases