University of Miami, Coral Gables, USA.
J Gen Intern Med. 2012 Dec;27(12):1594-601. doi: 10.1007/s11606-012-2122-5. Epub 2012 Jun 13.
Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL).
To assess changes in HRQoL after interventions aimed at diabetes risk reduction.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups.
Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB).
HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %.
After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score.
Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.
患有糖尿病高危人群的成年人其健康相关生活质量(HRQoL)可能会下降。
评估旨在降低糖尿病风险的干预措施对 HRQoL 的影响。
设计、设置和参与者:一项在美国 27 个中心进行的随机临床试验,即糖尿病预防计划(Diabetes Prevention Program),纳入了 3234 名空腹和餐后血糖升高、平均年龄 51 岁、平均 BMI 34kg/m²、68%为女性、45%为少数族裔的非糖尿病患者。
强化生活方式(ILS)计划,目标是至少减轻 7%的体重并每周进行 150 分钟的体育活动,二甲双胍(MET)850mg 每日两次,或安慰剂(PLB)。
使用 36 项简短健康调查问卷(SF-36)评估健康效用指数(SF-6D)、身体成分综合评分(PCS)和精神成分综合评分(MCS)来评估 HRQoL。当组间 HRQoL 评分的平均值相差至少 3%时,就达到了最小重要差异(MID)。
在平均 3.2 年的随访后,ILS 组的 SF-6D(+0.008,p=0.04)和 PCS(+1.57,p<0.0001)评分均有显著改善,但 MET 组的评分无显著变化(分别为+0.002 和+0.15,p=0.6),与 PLB 组相比。与 PLB 组相比,ILS 组的一般健康(+3.2,p<0.001)、身体功能(+3.6,p<0.001)、躯体疼痛(+1.9,p=0.01)和活力(+2.1,p=0.01)领域评分也有显著改善。在依次调整基线人口统计学因素和医疗及心理合并症后,治疗效果仍然显著。增加的体力活动和体重减轻介导了这些 ILS 治疗效果。与有治疗相关(ILS 或 MET)体重减轻的参与者相比,体重增加的参与者在相同的 HRQoL 特定领域的状况显著恶化。ILS 或 MET 对 MCS 评分没有益处。
对于有糖尿病高危因素的超重/肥胖成年人来说,通过 ILS 干预实现的体重减轻和增加体力活动,他们的大多数身体 HRQoL 和活力评分都有轻度改善。