Dataset Information

Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH.

ABSTRACT:

Background aims

Lifestyle intervention remains the foundation of clinical care for patients with NASH; however, most patients are unsuccessful in enacting sustained behavioral change. There remains a clear unmet need to develop lifestyle intervention programs to support weight loss. Mobile health (mHealth) programs offer promise to address this need, yet their efficacy remains unexplored.

Approach results

We conducted a 16-week randomized controlled clinical trial involving adults with NASH. Patients were randomly assigned (1:1 ratio) to receive Noom Weight (NW), a mHealth lifestyle intervention program, or standard clinical care. The primary end point was a change in body weight. Secondary end points included feasibility (weekly app engagement), acceptability (>50% approached enrolled), and safety. Of 51 patients approached, 40 (78%) were randomly assigned (20 NW and 20 standard clinical care). NW significantly decreased body weight when compared to standard clinical care (-5.5 kg vs. -0.3 kg, p = 0.008; -5.4% vs. -0.4%, p = 0.004). More NW subjects achieved a clinically significant weight loss of ≥5% body weight (45% vs. 15%, p = 0.038). No adverse events occurred, and the majority (70%) of subjects in the NW arm met the feasibility criteria.

Conclusions

This clinical trial demonstrated that NW is not only feasible, acceptable, and safe but also highly efficacious because this mHealth lifestyle intervention program led to significantly greater body weight loss than standard clinical care. Future large-scale studies are required to validate these findings with more representative samples and to determine if mHealth lifestyle intervention programs can lead to sustained, long-term weight loss in patients with NASH.

SUBMITTER: Stine JG

PROVIDER: S-EPMC10027041 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH.

Stine Jonathan G JG Rivas Gloriany G Rivas Gloriany G Hummer Breianna B Duarte-Rojo Andres A May Christine N CN Geyer Nathaniel N Chinchilli Vernon M VM Conroy David E DE Mitchell Ellen Siobhan ES McCallum Meaghan M Michealides Andreas A Schmitz Kathryn H KH

Hepatology communications 20230317 4

<h4>Background aims</h4>Lifestyle intervention remains the foundation of clinical care for patients with NASH; however, most patients are unsuccessful in enacting sustained behavioral change. There remains a clear unmet need to develop lifestyle intervention programs to support weight loss. Mobile health (mHealth) programs offer promise to address this need, yet their efficacy remains unexplored.<h4>Approach results</h4>We conducted a 16-week randomized controlled clinical trial involving adults ...[more]

PMID: 36930864

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Project description:BackgroundLong-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.ObjectiveWe 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.MethodsIn 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.ResultsData 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).ConclusionsCompared 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 registrationClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915.

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Dataset Information

Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH.

Background aims

Approach results

Conclusions

Publications

Mobile health lifestyle intervention program leads to clinically significant loss of body weight in patients with NASH.

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