Dietary Habits, Type 2 Diabetes Mellitus
Conditions
Keywords
Smartphone application, HbA1c, Blood lipids, Dietary intake
Brief summary
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.
Interventions
BEHAVIORALApp-technology for healthy eating habits
Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of type 2 diabetes * 18 years of age or older * Ability to communicate in Swedish * Own and use a smartphone with a personal digital ID
Exclusion criteria
\- No specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dietary intake | Baseline and month 3, and 6 | Change in dietary intake assessed using a four day food record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | Baseline and month 3, and 6 | mmol/L |
| HbA1c | Baseline and month 3, and 6 | mmol/mol, Heamoglobin A1c |
| HDL-cholesterol | Baseline and month 3, and 6 | mmol/L |
| Triglycerides | Baseline and month 3, and 6 | mmol/L |
| Body Mass Index (BMI) | Baseline and month 3, and 6 | kg/m2, measured height and weight |
| Body weight | Baseline and month 3, and 6 | kg, measured |
| Body composition: Body fat | Baseline and month 3, and 6 | Body fat (kg), measured using a bioelectrical scale |
| Body composition: Fat free mass | Baseline and month 3, and 6 | Fat free mass (kg), measured using a bioelectrical scale |
| Body composition: Muscle mass | Baseline and month 3, and 6 | Muscle mass (kg), measured using a bioelectrical scale |
| Body composition: Total body water | Baseline and month 3, and 6 | Total body water (kg), measured using a bioelectrical scale |
| Waist circumference | Baseline and month 3, and 6 | cm, measured |
| Blood pressure | Baseline and month 3, and 6 | mmHg, measured |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity assessed using the Active-Q questionnaire | Baseline and month 3, 6 and 12 | Assessed using a 48 item questionnaire including activities in domains of Daily occupation, transportation, leisure time, and exercise |
| Change in self-reported medication use | Baseline and month 3, 6 and 12 | One question on medication use for blood sugar levels and one questions on medication use for blood lipid levels |
| Change in tobacco use habits | Baseline and month 3, 6 and 12 | Two questions regarding smoking and Swedish snuff use |
| Change in sleeping habits | Baseline and month 3, 6 and 12 | Assessed using a modified 13-item Karolinska Sleep questionnaire |
| Change in perceived purpose in Life (PIL) | Baseline and month 3, 6 and 12 | Assessed using 6-item questionnaire |
| Change in perceived stress levels | Baseline and month 3, 6 and 12 | Assessed using the 14-item perceived stress scale (PSS) |
| Change in self-reported diabetes self-efficacy | Baseline and month 3, 6 and 12 | Assessed using a 20-item questionnaire |
| Change in health related quality of life | Baseline and month 3, 6 and 12 | Assessed using the 36-item RAND-36 questionnaire |
| Change in perceived social support from family and friends for healthy eating habits | Baseline and month 3, 6 and 12 | Assessed using a 3-item questionnaire |
| Change in eating behaviour assessed using Three-Factor Eating Questionnaire-R21 (TFEQ-R21) | Baseline and month 3, 6 and 12 | Assessed using a 21-item questionnaire |
| Change in dietary intake and eating habits | Baseline and month 3, 6 and 12 | Assessed using a 94 item food frequency questionnaire (FFQ) |
Countries
Sweden
Outcome results
None listed