The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Change in dietary intake
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria apply
Arms & Interventions
App-technology group
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.
Intervention: App-technology for healthy eating habits (Behavioral)
Control group
The control group will receive standard care.
Outcomes
Primary Outcomes
Change in dietary intake
Time Frame: Baseline and month 3, and 6
Change in dietary intake assessed using a four day food record.
Secondary Outcomes
- HbA1c(Baseline and month 3, and 6)
- HDL-cholesterol(Baseline and month 3, and 6)
- Total cholesterol(Baseline and month 3, and 6)
- Body Mass Index (BMI)(Baseline and month 3, and 6)
- Body weight(Baseline and month 3, and 6)
- Body composition: Body fat(Baseline and month 3, and 6)
- Waist circumference(Baseline and month 3, and 6)
- Triglycerides(Baseline and month 3, and 6)
- Body composition: Fat free mass(Baseline and month 3, and 6)
- Body composition: Muscle mass(Baseline and month 3, and 6)
- Body composition: Total body water(Baseline and month 3, and 6)
- Blood pressure(Baseline and month 3, and 6)
Investigators
Stephanie Bonn
PhD, Assistant professor
Karolinska Institutet