The Healthy Eating With APP technologY Study

Study Overview
=================
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.

Official Title
-----------------
The HAPPY-study: Digital Support for Healthier Eating Habits in Patients With Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care

Conditions
-----------------
Type 2 Diabetes Mellitus, Dietary Habits

Intervention / Treatment
-----------------
* Behavioral: App-technology for healthy eating habits


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-technology group<br>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. | Behavioral: App-technology for healthy eating habits<br>* Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.<br>|
| No Intervention: Control group<br>The control group will receive standard care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smartphone application, HbA1c, Blood lipids, Dietary intake