A single-blind, randomised controlled trial of a physical health nurse intervention to prevent weight gain and metabolic complications in first-episode psychosis: the Physical Health Assistance in Early Psychosis (PHAstER) study

一项单盲、随机对照试验,旨在评估身体健康护士干预对预防首发精神病患者体重增加和代谢并发症的效果:早期精神病身体健康援助(PHAstER)研究

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Abstract

BACKGROUND: Factors that contribute to the early mortality observed in psychotic disorders, specifically obesity, smoking and sedentary behaviour, occur early in the disorder. AIMS: We aimed to determine whether the integration of a physical health nurse in the care of young people with first-episode psychosis could prevent clinically significant weight gain (≥7% body weight). Secondary outcomes included rates of smoking, metabolic syndrome and sedentary behaviour. METHOD: In this single-blind, randomised controlled trial, participants who had received under 4 weeks of antipsychotic medication were randomly allocated to either the intervention (addition of a physical health nurse to their care) or treatment as usual (TAU) for 12 weeks. RESULTS: Of the 77 participants, there were follow-up data for 86.8% (n = 33) of the intervention group and 82.1% (n = 32) of the TAU group. After 12 weeks, 27.3% of the intervention group experienced clinically significant weight gain compared with 34.4% of the TAU group (odds ratio 0.72, 95% CI 0.25-2.06, P = 0.54). After 6 months, 40.7% of the intervention group gained clinically significant weight compared with 44.1% of the TAU group (P = 0.79). There was no difference in mean change in weight between groups after 12 weeks (2.6 kg v. 2.9 kg, P = 0.87) or 6 months (3.6 kg v. 4.3 kg, P = 0.64). There were no differences in the rates of tobacco smoking cessation, prevalence of metabolic syndrome or physical activity levels. CONCLUSIONS: This intervention failed to prevent the metabolic complications that are highly prevalent in psychotic disorders in the short to medium term, indicating that more intensive interventions are required.

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