Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 18, 2020
Date Accepted: Oct 20, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Digital support for healthier eating habits in patients with type 2 diabetes: Protocol for the HAPPY-study, a randomized clinical trial within primary care
ABSTRACT
Background:
Despite the large impact that dietary habits have in the management of diabetes, few tools for supporting healthy eating habits are available for persons with diabetes.
Objective:
The aim of this randomized clinical trial is to evaluate the effect of a 12-week long mHealth app-based intervention promoting healthy eating habits among patients with type 2 diabetes. The effect of the intervention on dietary intake (primary outcome) and levels of HbA1c (glycated hemoglobin), blood lipids, body composition, blood pressure, as well as other lifestyle factors and overall health (secondary outcomes), will be assessed.
Methods:
The HAPPY-study (Healthy eating using APP technologY) is a randomized clinical trial with two arms aiming to include 200 patients with type 2 diabetes. Study participants are randomized 1:1 to an intervention group and are instructed to use a smartphone-app promoting healthy eating, or a control group that receives standard primary care only, during 12 weeks. Each week a new topic, e.g. vegetable intake, is introduced in the app. After an introduction text, the user is given an activity related to the topic to perform, e.g. to add one portion of vegetables per day during that week. The app records daily progress and sends automatic reminders or feedback to the user. Dietary intake, body composition, clinical variables, and biomarkers, are measured at baseline and after 3- and 6-months of follow-up. An extensive web-based questionnaire assessing a number of lifestyle factors, including for example sleep, physical activity, eating behavior, and health related quality of life, is distributed via email at baseline, 3-, 6-, and 12-months of follow-up.
Results:
Data collection is ongoing. Recruitment of participants started in January 2019. Findings from the study are expected to be published by the end of 2021.
Conclusions:
Technology development provides new ways to promote and support long-term adherence to healthier eating habits. mHealth based approaches allows for real-time interaction and the delivery of an intervention at any time. Further, focusing on overall diet allows the user to apply new knowledge to current eating patterns, creating an individualized approach. In this study, we evaluate the effect of using a new smartphone-app promoting healthy eating habits on dietary intake, clinical markers and lifestyle factors, among patients with type 2 diabetes. Clinical Trial: ClinicalTrials.gov Identifier: NCT03784612. First posted: December 24, 2018. Last Updated: February 19, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT03784612
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