Previously submitted to: JMIR Diabetes (no longer under consideration since Jan 24, 2022)
Date Submitted: Jan 21, 2021
Warning: This is an author submission that is not peer-reviewed or edited.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.
Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Web-based Lifestyle Coaching Program in Denmark: Randomized Controlled Trial
ABSTRACT
Background:
Lifestyle interventions can delay and reverse the onset of type 2 diabetes (T2D) and decrease morbidity and mortality. Studies suggest that digital coaching based on real-time monitoring can lead to clinically relevant weight loss, as well as decreased or normalized hemoglobin A1c (HbA1c) for a significant number of patients.
Objective:
To assess whether an eHealth lifestyle coaching program (LIVA 2.0) for patients with T2D who are motivated for lifestyle changes leads to significant weight loss and decreased HbA1c, compared to usual care.
Methods:
In a randomized controlled single-blinded trial, 170 patients with T2D were enrolled from March 2018 to March 2019 and randomized to the intervention (100) and control (70) groups. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The intervention comprised an initial face-to-face motivational interview followed by digital coaching. The same healthcare professional coach provided synchronous and asynchronous multimodal feedback and used digital behavioral change techniques enabled by an app providing live monitoring of lifestyle behaviors. Primary outcome was body weight. Secondary outcomes were changes in HbA1c, body composition, lipids, and quality of life at 6 months.
Results:
At 6 months, 75 patients (75%) in the intervention group and 53 patients (76%) in the control group remained in the study. Mean body weight loss was 4.2 kg (95% CI, 5.5- 3.0) in the intervention group vs 1.5 kg (95% CI, 2.57- 0.48) in the control group (P = .005). In the intervention group, 36 (52%) patients lost > 3% body weight, compared to 12 (32%) patients in the control group. Mean HbA1c was lower in both groups at 6 months, with reductions of 8.2% (95% CI, 11.01 to 5.29) and 5.5% (95% CI, 8.75 to 2.76) for the intervention and control groups, respectively (P = .203). In the intervention group, 24 (32%) had an HbA1c <6.5% at 6 months, compared to 8 (15%) in the control group (P = .03).
Conclusions:
Reduction in body weight and remission rate for HbA1c, as well as improved body composition can be enhanced by using digital lifestyle coaching for patients with T2D. Clinical Trial: Trial Registration: Clinicaltrials.gov NCT03788915 https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR2-10.2196/19172
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