Health Psychology Group, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.
PLoS One. 2011;6(8):e23040. doi: 10.1371/journal.pone.0023040. Epub 2011 Aug 29.
Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.
Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.
Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.
The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.
Controlled-Trials.com ISRCTN90101501.
对于肥胖成年人，改变饮食和体力活动的干预措施可能对伴有其他肥胖相关风险因素和合并症的参与者效果不如对其他健康个体。本研究旨在检验一项针对肥胖伴有肥胖相关合并症（如 2 型糖尿病、葡萄糖耐量受损或高血压）成年人改善体力活动和饮食实践的干预措施的随机对照试验的招募、分配、测量、保留和干预程序的可行性和可接受性。
对肥胖（体重指数（BMI）≥30 kg/m2）成年人（年龄≥18 岁）进行的单中心开放标签结局评估者设盲随机对照试验，这些参与者患有肥胖相关合并症，如 2 型糖尿病、葡萄糖耐量受损或高血压。参与者按照 2:1 的分配比例随机分配到基于手册的小组干预组或传单对照组。主要结局是试验程序的可接受性和可行性，次要结局包括身体成分、体力活动、食物摄入和心理过程测量。
通过在两家初级保健全科医疗实践中的列表搜索，确定了 806 名潜在合格个体，共有 81 名参与者（63%为女性；平均年龄为 56.56(11.44)；平均 BMI 为 36.73(6.06)），伴有 2.35(1.47)种合并症被随机分配。苏格兰多重剥夺指数（SIMD）是同意参加研究的唯一显著预测因素（剥夺程度较低的邀请者同意参加研究的可能性更大）。参与者流程图、定性和定量反馈表明干预程序的接受度和可行性良好，但由于测量负担过高和保留程序不理想，34.6%的随机参与者失访。干预组的参与者在大多数心理、行为和身体成分结果上表现出积极的趋势。
干预措施被认为是可接受和可行的。但失访率高得不可接受，确定了改进试验程序的领域。
Controlled-Trials.com ISRCTN90101501。
