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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-technology group | Experimental | 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 |
|
| Control group | No Intervention | The control group will receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-technology to increase physical activity | Behavioral | Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity level (counts/min from accelerometers) | baseline and month 3, 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (mmol/mol) | Baseline and month 3, 6 and 12 | |
| Steps/day | Baseline and month 3, 6 and 12 | |
| Total cholesterol (mmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary habits assessed using a food frequency questionnaire | Baseline and month 3, 6 and 12 | |
| Change in tobacco use habits (smoking and Swedish snuff use) | Baseline and month 3, 6 and 12 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ylva Trolle Lagerros, MD, PhD | Karolinska Institutet and Stockholm County Councill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38512333 | Derived | Bonn SE, Hummel M, Peveri G, Eke H, Alexandrou C, Bellocco R, Lof M, Trolle Lagerros Y. Effectiveness of a Smartphone App to Promote Physical Activity Among Persons With Type 2 Diabetes: Randomized Controlled Trial. Interact J Med Res. 2024 Mar 21;13:e53054. doi: 10.2196/53054. | |
| 36732788 | Derived | Sjoblom L, Bonn SE, Alexandrou C, Dahlgren A, Eke H, Trolle Lagerros Y. Dietary habits after a physical activity mHealth intervention: a randomized controlled trial. BMC Nutr. 2023 Feb 2;9(1):23. doi: 10.1186/s40795-023-00682-4. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline and month 3, 6 and 12 |
| HDL-cholesterol (mmol/L) | Baseline and month 3, 6 and 12 |
| Triglycerides (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 | Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %) | Baseline and month 3, 6 and 12 |
| Waist circumference (cm) | Baseline and month 3, 6 and 12 |
| Blood pressure (mmHg) | Baseline and month 3, 6 and 12 |
| Change in sleeping habits assessed using a 13 item questionnaire |
| Baseline and month 3, 6 and 12 |
| Change in perceived purpose in life | Baseline and month 3, 6 and 12 |
| Change in perceived stress levels using the perceived stress scale | Baseline and month 3, 6 and 12 |
| Change in reported self-efficacy for exercise | One's confidence in walking is assessed | Baseline and month 3, 6 and 12 |
| Change in reported self-efficacy diabetes is assessed using a 20 item questionnaire | Baseline and month 3, 6 and 12 |
| Change in RAND-36 | Baseline and month 3, 6 and 12 |
| Change in neighborhood Environment assessed by questions on safety and walking environment | Baseline and month 3, 6 and 12 |
| Social support for exercise assessed using a 6 item questionnaire | Baseline and month 3, 6 and 12 |
| 36528609 | Derived | Hummel M, Bonn SE, Trolle Lagerros Y. The effect of the smartphone app DiaCert on health related quality of life in patients with type 2 diabetes: results from a randomized controlled trial. Diabetol Metab Syndr. 2022 Dec 17;14(1):192. doi: 10.1186/s13098-022-00965-z. |
| 29316905 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |