Vargas Maria C, Katz Joshua B, Lopez Azucena, Carrillo Arturo, Gregory Dyanna L, O'Brien Matthew J
Institute of Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.
Division of General Internal Medicine and Geriatrics, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.
Sci Rep. 2024 Dec 30;14(1):31988. doi: 10.1038/s41598-024-83482-5.
The objective of this study was to develop and evaluate a novel behavioral intervention (PRIME2) that integrates evidence-based approaches for reducing diabetes risk and perceived stress. We conducted a pilot randomized controlled trial of the 16-session PRIME2 intervention vs. usual care among 40 Spanish-speaking Latinx adults with prediabetes and body mass index (BMI) ≥ 25 kg/m. The 3-month change in weight and perceived stress were co-primary outcomes. Secondary outcomes were 3-month changes in hemoglobin A1c (HbA1c), blood pressure, and depressive symptoms. Study participants were women (95%) with mean age 49.9 (± 9.3) years, moderate levels of perceived stress, and risk factors for diabetes, including mean BMI 33.3 (± 5.4) kg/m and elevated HbA1c [mean 6.0% (± 0.2)]. PRIME2 participants demonstrated significantly greater 3-month weight loss relative to usual care (- 3.7lbs, p = 0.02). Reductions in perceived stress in both study arms were similar. There were no significant differences in secondary outcomes among PRIME2 participants vs. usual care. This pilot trial demonstrates the feasibility and preliminary weight loss effectiveness of the novel PRIME2 intervention, without observing a significant difference in perceived stress between study arms. Future research should include larger randomized samples that enable a definitive evaluation of intervention effects on both metabolic and mental health endpoints.
本研究的目的是开发并评估一种新型行为干预措施（PRIME2），该措施整合了基于证据的方法以降低糖尿病风险和感知压力。我们对40名患有糖尿病前期且体重指数（BMI）≥25 kg/m²的讲西班牙语的拉丁裔成年人进行了一项试点随机对照试验，比较了为期16节的PRIME2干预措施与常规护理。体重和感知压力的3个月变化是共同主要结局。次要结局是糖化血红蛋白（HbA1c）、血压和抑郁症状的3个月变化。研究参与者为女性（95%），平均年龄49.9（±9.3）岁，感知压力处于中等水平，且有糖尿病风险因素，包括平均BMI为33.3（±5.4）kg/m²以及HbA1c升高[平均6.0%（±0.2）]。与常规护理相比，PRIME2参与者在3个月时体重减轻显著更多（-3.7磅，p = 0.02）。两个研究组在感知压力降低方面相似。PRIME2参与者与常规护理在次要结局方面无显著差异。这项试点试验证明了新型PRIME2干预措施的可行性和初步的体重减轻效果，且未观察到两个研究组在感知压力方面存在显著差异。未来的研究应纳入更大的随机样本，以便能够对干预对代谢和心理健康终点的影响进行确定性评估。
