Background <p>Emerging evidence suggests that digital therapies are effective for treating obesity; however, an evidence gap exists regarding the potency of stand-alone digital therapeutics with limited additional support from a health care professional. This randomized controlled trial examined the efficacy of a digital health application for weight management in people with obesity.</p> Methods <p>The decentralized digital randomized controlled trial included 164 adults with obesity (BMI 30–45 kg/m²) from Germany who were randomly assigned to either an intervention group (receiving a digital health application for weight management for 6 months) or a control group (receiving care as usual for 6 months). Data on weight (primary endpoint at 6 months), quality of life (WHOQOL-BREF), and food literacy (SFLQ) were collected at baseline, 3, and 6 months.</p> Results <p>Participants (<i>n</i> = 164; 42% female, 58% male) had a mean BMI of 37.82 ± 4.25 kg/m² and a mean age of 45.92 ± 10.66 years. At 6 months, the intervention group achieved a mean weight loss of 5.29% ([95% CI: −6.73% to −3.86%], <i>p</i> &lt; 0.001) compared to 1.76% ([95% CI: −3.10% to −0.42%], <i>p</i> = 0.010) in the control group (estimated marginal mean difference (EMMD): −3.53% [95% CI: −5.16% to −1.91%]; <i>p</i> &lt; 0.001) with a large effect size (<i>d</i> = 0.80, [95% CI: 0.43–1.19]). Compared to controls at 6 months, food literacy (EMMD: 2.77, <i>d</i> = 0.49, <i>p</i> &lt; 0.001) and perceived overall quality of life (EMMD: 0.33, <i>d</i> = 0.40, <i>p</i> = 0.010) improved in the intervention group, though no differences in the four quality of life domains were found.</p> Conclusions <p>The digital health application for weight management demonstrated efficacy in achieving weight loss (&gt;5%) in people with obesity at 6 months.</p> Trial registration <p>This study was registered in the German Clinical Trials Register (Registration number: DRKS00033045).</p>

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Efficacy of a digital health application for weight management in people with obesity: 6-months results from a randomized controlled trial

  • Anne Lautenbach,
  • Matthias Blüher,
  • Ana Mijuskovic,
  • Lucy Jones,
  • Felix Schirmann

摘要

Background

Emerging evidence suggests that digital therapies are effective for treating obesity; however, an evidence gap exists regarding the potency of stand-alone digital therapeutics with limited additional support from a health care professional. This randomized controlled trial examined the efficacy of a digital health application for weight management in people with obesity.

Methods

The decentralized digital randomized controlled trial included 164 adults with obesity (BMI 30–45 kg/m²) from Germany who were randomly assigned to either an intervention group (receiving a digital health application for weight management for 6 months) or a control group (receiving care as usual for 6 months). Data on weight (primary endpoint at 6 months), quality of life (WHOQOL-BREF), and food literacy (SFLQ) were collected at baseline, 3, and 6 months.

Results

Participants (n = 164; 42% female, 58% male) had a mean BMI of 37.82 ± 4.25 kg/m² and a mean age of 45.92 ± 10.66 years. At 6 months, the intervention group achieved a mean weight loss of 5.29% ([95% CI: −6.73% to −3.86%], p < 0.001) compared to 1.76% ([95% CI: −3.10% to −0.42%], p = 0.010) in the control group (estimated marginal mean difference (EMMD): −3.53% [95% CI: −5.16% to −1.91%]; p < 0.001) with a large effect size (d = 0.80, [95% CI: 0.43–1.19]). Compared to controls at 6 months, food literacy (EMMD: 2.77, d = 0.49, p < 0.001) and perceived overall quality of life (EMMD: 0.33, d = 0.40, p = 0.010) improved in the intervention group, though no differences in the four quality of life domains were found.

Conclusions

The digital health application for weight management demonstrated efficacy in achieving weight loss (>5%) in people with obesity at 6 months.

Trial registration

This study was registered in the German Clinical Trials Register (Registration number: DRKS00033045).