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Randomized Controlled Trial
. 2022 Sep 23;24(9):e39741.
doi: 10.2196/39741.

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial

Affiliations
Randomized Controlled Trial

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial

Laura Hesseldal et al. J Med Internet Res. .

Abstract

Background: Long-term weight loss in people living with obesity can reduce the risk and progression of noncommunicable diseases. Observational studies suggest that digital coaching can lead to long-term weight loss.

Objective: We investigated whether an eHealth lifestyle coaching program for people living with obesity with or without type 2 diabetes led to significant, long-term (12-month) weight loss compared to usual care.

Methods: In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 people living with obesity with or without type 2 diabetes were enrolled from April 16, 2018, to April 1, 2019, and randomized via an automated computer algorithm to an intervention (n=200) or a control (n=140) group. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The digital coaching intervention consisted of an initial 1-hour face-to-face motivational interview followed by digital coaching using behavioral change techniques enabled by individual live monitoring. The primary outcome was change in body weight from baseline to 12 months.

Results: Data were assessed for 200 participants, including 127 from the intervention group and 73 from the control group, who completed 12 months of follow-up. After 12 months, mean body weight and BMI were significantly reduced in both groups but significantly more so in the intervention group than the control group (-4.5 kg, 95% CI -5.6 to -3.4 vs -1.5 kg, 95% CI -2.7 to -0.2, respectively; P<.001; and -1.5 kg/m2, 95% CI -1.9 to -1.2 vs -0.5 kg/m2, 95% CI -0.9 to -0.1, respectively; P<.001). Hemoglobin A1c was significantly reduced in both the intervention (-6.0 mmol/mol, 95% CI -7.7 to -4.3) and control (-4.9 mmol/mol, 95% CI -7.4 to -2.4) groups, without a significant group difference (all P>.46).

Conclusions: Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, after 12 months.

Trial registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915.

Keywords: T2D; behavior changes; coaching; diabetes; digital behavioral coaching; digital coach; digital health; eHealth; engagement; health behavior change; interactive advice; lifestyle change; mobile intervention; obesity; patient engagement; telemedicine; training; type 2 diabetes; weight loss.

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Conflict of interest statement

Conflicts of Interest: This study acquired no external funding. All authors were financially supported by their employer, the University of Southern Denmark, except DHL, who was financially supported by LIVA Healthcare A/S, which also paid for the coaching and instruments used in the study. A formal research agreement has been made between the University of Southern Denmark and LIVA Healthcare A/S to guarantee that LIVA Healthcare A/S cannot influence any results of the study, and in case there is any doubt, JS and the University of Southern Denmark have the final say. CJB is an original cofounder of LIVA Healthcare A/S and owns stock in LIVA Healthcare A/S, the company that developed parts of the technical platform. CJB works today at the Research Unit for General Practice at the University of Southern Denmark and as a consultant to LIVA Healthcare A/S. DHL is employed at LIVA Healthcare A/S. DHL primarily contributed information about the use of the LIVA app in clinical practice. LH, JRC, TBO, MHO, PRJ, JTL, JBN, and JS have no financial interests in LIVA Healthcare A/S or any other aspects of this study.

Figures

Figure 1
Figure 1
Flowchart of participation in 12-month randomized controlled trial. *Failed to appear at the assessment but appeared at the next follow-up.
Figure 2
Figure 2
Body weight and hemoglobin A1c at baseline, at the 6-month follow-up (n=197), and at the 12-month follow-up (n=200) in subgroups with and without type 2 diabetes. Dots indicate the mean and lines indicate the standard error of the mean. Pw: P value for changes from baseline within groups; Pb: P value for changes from baseline between groups; Px: P value for changes from 6 to 12 months within groups; HbA1c: hemoglobin A1c; T2D: type 2 diabetes.

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