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The aim of this study is to investigate the effect of using new app-based technology to improve dietary habits, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology an an app-based course for healthy eating habits, will have a greater positive effect on dietary habits and biological markers, including HbA1c and serum lipids, than usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-technology group | Experimental | Participants in the App-technology group arm will use a newly developed smartphone application ("app"), containing a 12-week healthy eating program. Intervention: App-technology for healthy eating habits. |
|
| Control group | No Intervention | The control group will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-technology for healthy eating habits | Behavioral | Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary intake | Change in dietary intake assessed using a four day food record. | Baseline and month 3, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | mmol/mol, Heamoglobin A1c | Baseline and month 3, and 6 |
| Total cholesterol | mmol/L | Baseline and month 3, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary intake and eating habits | Assessed using a 94 item food frequency questionnaire (FFQ) | Baseline and month 3, 6 and 12 |
| Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21) |
Inclusion Criteria:
Exclusion criteria:
- No specific exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie E Bonn, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40510749 | Derived | Cecchini V, Sjoblom L, Lagerros YT, Bonn SE. The Effect of a Mobile Health Dietary Education Intervention on Ultra-processed Food Consumption in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Curr Dev Nutr. 2025 Apr 28;9(6):107454. doi: 10.1016/j.cdnut.2025.107454. eCollection 2025 Jun. | |
| 39754157 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| HDL-cholesterol | mmol/L | Baseline and month 3, and 6 |
| Triglycerides | mmol/L | Baseline and month 3, and 6 |
| Body Mass Index (BMI) | kg/m2, measured height and weight | Baseline and month 3, and 6 |
| Body weight | kg, measured | Baseline and month 3, and 6 |
| Body composition: Body fat | Body fat (kg), measured using a bioelectrical scale | Baseline and month 3, and 6 |
| Body composition: Fat free mass | Fat free mass (kg), measured using a bioelectrical scale | Baseline and month 3, and 6 |
| Body composition: Muscle mass | Muscle mass (kg), measured using a bioelectrical scale | Baseline and month 3, and 6 |
| Body composition: Total body water | Total body water (kg), measured using a bioelectrical scale | Baseline and month 3, and 6 |
| Waist circumference | cm, measured | Baseline and month 3, and 6 |
| Blood pressure | mmHg, measured | Baseline and month 3, and 6 |
Assessed using a 21-item questionnaire
| Baseline and month 3, 6 and 12 |
| Change in physical activity assessed using the Active-Q questionnaire | Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise | Baseline and month 3, 6 and 12 |
| Change in self-reported medication use | One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels | Baseline and month 3, 6 and 12 |
| Change in tobacco use habits | Two questions regarding smoking and Swedish snuff use | Baseline and month 3, 6 and 12 |
| Change in sleeping habits | Assessed using a modified 13-item Karolinska Sleep questionnaire | Baseline and month 3, 6 and 12 |
| Change in perceived purpose in Life (PIL) | Assessed using 6-item questionnaire | Baseline and month 3, 6 and 12 |
| Change in perceived stress levels | Assessed using the 14-item perceived stress scale (PSS) | Baseline and month 3, 6 and 12 |
| Change in self-reported diabetes self-efficacy | Assessed using a 20-item questionnaire | Baseline and month 3, 6 and 12 |
| Change in health related quality of life | Assessed using the 36-item RAND-36 questionnaire | Baseline and month 3, 6 and 12 |
| Change in perceived social support from family and friends for healthy eating habits | Assessed using a 3-item questionnaire | Baseline and month 3, 6 and 12 |
| Sjoblom L, Hantikainen E, Dahlgren A, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary education on dietary intake and cardiometabolic risk markers in people with type 2 diabetes: results from a randomized controlled trial. Nutr J. 2025 Jan 4;24(1):2. doi: 10.1186/s12937-024-01069-2. |
| 37821876 | Derived | Pitt S, Sjoblom L, Balter K, Trolle Lagerros Y, Bonn SE. The effect of an app-based dietary intervention on diet-related greenhouse gas emissions - results from a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 11;20(1):123. doi: 10.1186/s12966-023-01523-0. |
| 33196448 | Derived | Trolle Lagerros Y, Dahlgren A, Sjoblom L, Bonn SE. Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial). JMIR Res Protoc. 2020 Nov 16;9(11):e24422. doi: 10.2196/24422. |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |