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临床试验/ACTRN12619001606178
ACTRN12619001606178已完成未知

Halting unintentional weight gain after adult lung transplantation (HALT): a pilot study

Alfred Health Research0 个研究点目标入组 30 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

研究概览

简要总结

Research question 1. Can group education sessions and individual phone coaching reduce unintentional gains in weight, fat mass, waist circumference and visceral adipose tissue over 1 year? 2. Can the intervention improve nutrition knowledge, diet quality and physical activity? Background information Weight gain following transplantation is well established, although the mechanisms are unclear. Unintentional weight gain, overweight and obesity following transplant are linked to graft dysfunction, hypertension, dyslipidaemia and diabetes. There have been no weight management intervention studies involving lung transplant recipients. Participant characteristics Control =14, Intervention=15 Average age years 59.8, 67.9 Male gender 71.4, 73.3% Caucasian 92.9%, 100% Average height metres 1.69, 1.69 Average weight kilograms 76.3, 73.7 Average Body Mass Index kg/m2 26.6, 25.7 Key Results There were no significant differences between groups at any timepoint for: • Anthropometry measures • Nutrition knowledge • Physical activity There was a significantly higher dairy intake among the intervention group at 12-months, otherwise there were no significant differences in food group intake at any timepoint. Limitations • The pilot study was not able to demonstrate significance • It was not possible to randomise participants or blind investigators • Six intervention participants experienced coronavirus-related periods of lockdown which may have led to greater weight gain • Self-reported measures of diet and physical activity can be imprecise • The intervention group was significantly older and had a higher prevalence of single lung transplants among the intervention group weakened comparison between groups

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • All Alfred Health lung transplant recipients
  • Able and willing to provide informed consent to participate in the study
  • Aged greater than or equal to 18 years old
  • Resident of Victoria

排除标准

  • BMI less than or equal to 20kg/m2 during admission post-transplant
  • Expected to require enteral nutrition upon discharge from hospital
  • Complex post-transplant admission (greater than 8 weeks from day of transplant)
  • English language proficiency insufficient to participate in group education and phone coaching sessions
  • Hearing impairment to a degree that would render participation in group education and phone coaching sessions impractical
  • South Australian and Tasmanian residents (due to transfer home at about 12 weeks post-transplant and therefore unable to undertake 12 month data collection)

研究者

发起方
Alfred Health Research

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