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The effect of lifestyle intervention on cardiometabolic risk factors in mental health rehabilitation hostel residents at-risk: a cluster-randomized controlled 15-month trial

Abstract

Objective

Cardiometabolic disorders contribute to morbidity and mortality in people with severe mental illnesses (SMI), yet lifestyle-intervention efficacy in patients with SMI is unclear. Israel’s unique mental-health rehabilitation hostels (MHRHs) provide housing to subjects with SMI. We tested how multi-component lifestyle intervention affects cardiometabolic risk-factors in at-risk SMI populations residing in MHRHs.

Methods

In a prospective, cluster-randomized, controlled study, six MHRHs, paired by residents’ functioning level, were randomized to lifestyle intervention (nutrition education, physical education), or usual care. Subjects recruited included those with ≥1 of: BMI > 25 kg/m2; plasma triglycerides ≥150 mg/dL; HbA1c ≥ 5.7%; fasting plasma glucose ≥ 100 mg/dL and plasma HDL < 40(men)/ 50(women) mg/dL. Primary outcome was BMI change after 15 months; other outcomes were plasma lipids levels and glycemic control. Low cooperation in one MHRH pair led to their exclusion, the others were assigned to intervention or control.

Results

Eighty residents were enrolled to intervention groups and 74 to control. Compared to baseline, intervention-arm participants experienced improvements in BMI (–0.83 kg/m2 [–1.36, –0.29] 95%CI), triglycerides (–30.60 mg/dL [–49.39, –11.82]95%CI) and LDL (–15.51 mg/dL [–24.53, –6.50]95%CI) (all P ≤ 0.003). BMI improvement correlated with number of dietitian consultations (r = –0.30; P = 0.001). No significant differences were found between treatment arms in BMI (–0.46 kg/m2 [–1.11, 0.18]95%CI;P = 0.189), triglycerides (–24.70 mg/dL [–57.66, 8.25]95%CI), LDL (–9.24 mg/dL [–20.50, 2.03]95%CI), HDL and glycemic control.

Conclusions

Lifestyle intervention significantly improved BMI, LDL and triglycerides compared to baseline in at-risk MHRHs residents with SMI, yet compared to usual care the differences did not reach statistical significance. The association between the number of dietitian’s consultations and BMI improvement suggests that programs should highlight participants’ adherence.

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Fig. 1: Study Design.
Fig. 2: Changes in measured parameters from baseline.
Fig. 3: Multivariate analysis of changes from baseline.
Fig. 4: Correlation between dietitian meetings and parameter changes from baseline.

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Acknowledgements

This study was funded by the Israeli Otzma Authority in 2015, grant number 3-12181. This paper was presented in part at the annual conference of Otzma Authority for the presentation of studies in diabetes (2018, October), Tel-HaShomer, Israel.

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Authors and Affiliations

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Contributions

FT- research concept and proposal, literature search, data collection and preliminary analysis, manuscript preparation. MS- data analysis, literature search, manuscript preparation, figure design. RG- research tools, preliminary data analysis, manuscript preparation. LP- research concept, literature search, data collection and preliminary analysis, manuscript preparation. VBK-literature search. AR- data analysis. IY - data analysis. YG - literature search, data analysis, manuscript preparation. OM- research concept, literature search, data analysis, manuscript review. RE- principal investigator, research concept, literature search, manuscript review. All authors read and approved the final version.

Corresponding author

Correspondence to Faina Tsodikov.

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Competing interests

OM declares Advisory Board from Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Novartis, AstraZeneca, BOL Pharma; Research grant support through Hadassah Hebrew University Hospital from Novo Nordisk, AstraZeneca; Speaker’s Bureau from AstraZeneca, Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Jansen. All other authors declare no conflict of interest.

Ethics approval and consent to participate

Authors confirm that the submitted study was conducted according to GCP and ICHH. The study was approved by the IRB of the Ministry of Health, Israel.

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Tsodikov, F., Schechter, M., Goldsmith, R. et al. The effect of lifestyle intervention on cardiometabolic risk factors in mental health rehabilitation hostel residents at-risk: a cluster-randomized controlled 15-month trial. Int J Obes 46, 926–934 (2022). https://doi.org/10.1038/s41366-022-01063-w

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