Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 6, 2020
Date Accepted: May 14, 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Warning: This is an author submission that is not peer-reviewed or edited.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.
Evaluating the Clinical and Economic Effects of a Primary Care Anchored Collaborative eHealth Lifestyle Coaching Program in Denmark: Protocol for a 2-year Randomized Controlled Trial
ABSTRACT
Background:
Obesity is linked to a number of chronic health conditions such as type 2 diabetes, heart disease and cancer, and weight loss interventions are often expensive. Recent systematic reviews conclude that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated.
Objective:
This study protocol for a 2-year randomized controlled trial (RCT) aims to evaluate the clinical and economic effects of a primary care anchored collaborative eHealth lifestyle coaching program (LIVA 2.0), comprising obese participants with and without type 2 diabetes. The program’s primary outcome is weight loss, its secondary outcome is HbA1c level and its tertiary outcomes are retention rates, quality of life (QOL) and cost effectiveness. Analytically, the focus is on associations between participant characteristics, and outcomes and sustainability.
Methods:
We conduct a multi-center trial with 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within Region of Southern Denmark and two municipalities located within Capital Region of Denmark. The participants will be assessed at baseline and at follow-up at 6, 12 and 24 months. Individual data from the LIVA 2.0 platform will be combined with clinical measurements, questionnaires and participants’ usage of municipality and health care services. The participants will have a BMI≥30<45 kg/m2, and 50% of the participants will also have type 2 diabetes. The participants are randomized in an approx. 60:40 manner and based on sample size calculations on weight loss and intention to treat statistics, 200 participants are randomized to intervention group and 140 to control group. The control group is offered the municipality’s conventional preventive program and it will be compared to the intervention group, which in addition to the conventional preventive municipal program, follows the LIVA 2.0.
Results:
The first baseline assessments were carried out in March 2018 and the 2-year follow-up will be carried out between March 2021 and April 2022. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who are normalizing their HbA1c levels in the intervention group will be significantly higher than those in the control group. The intervention group are also expected to decrease their use of glucose-lowering medication and improve their QOL significantly more compared to the control group. Operational costs are expected to be lower than standard care and to be cost-effective.
Conclusions:
This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 program proves itself to be effective, there is significant potential for decreasing obesity rates, diabetes and related chronic diseases. Clinical Trial: NCT03788915
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