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临床试验/NCT00694811
NCT00694811已完成4 期

Liquid Very-Low-Energy Diets (VLEDs) in Obesity Treatment. Effects of Re-Feeding Duration On Weight Maintenance, Eating Behaviour and Health-Related Quality of Life

Göteborg University1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2004年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
169
试验地点
1
主要终点
Weight development

研究概览

简要总结

The primary objective of the study is to test the hypothesis that prolonged re-feeding after VLED induced weight loss improves weight maintenance and eating behaviour

详细描述

VLED program:

During the initial 12 weeks, patients were encouraged to follow a strict liquid very-low-energy diet (470-820 kcal). They selected and paid themselves for one of the following commercially available diets; Modifast® (820 kcal), Nutrilett® (560 kcal) or Cambridgekuren® (470 kcal). Free consumption of non-caloric drinks (<6 kcal/100 g) was allowed. All patients had scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. Body weight was registered at each visit and patients were given support and counselling to enhance VLED compliance. Side effects were monitored and a more frequent contact was offered if needed. All patients were encouraged to be physically active.

Dietary treatment:

Following VLED, dietary treatment advice was given during individual dietician counseling at nine study visits (week 12, 15, 18, 21, 26, 32, 38, 44, and 52). At week 12, the dietician assigned patients with ≥10% weight loss to treatment group according to randomization. Standardized written and oral instructions for one or six week re-feeding were provided; hence, participants as well as study staff were aware of group assignment. During re-feeding, ordinary meals were gradually re-introduced and VLED portions removed. Patients with one week re-feeding (Group 1) (instructed at week 12) started with breakfast for three days, added lunch (or dinner) the next four days, and thereafter the third meal was re-introduced and VLED discontinued. Patients with six week re-feeding (Group 6) (instructed at week 12, 15, and 18) started with one regular meal (patient's choice) for three weeks. A second meal was added the next three weeks, and at week eight the third meal was re-introduced and VLED discontinued. For both groups between-meal snacks (e.g. fruit) were recommended from the completion of the re-feeding periods.

Recommended energy intake was based on an estimated energy requirement minus 30% to achieve an energy-reduced level. Energy requirement was calculated from the equation of Harris-Benedict for estimation of basal metabolic rate, adjusted by factor 1.3 for total energy expenditure (moderate level of physical activity). Recommended energy distribution for breakfast, lunch and dinner was 20, 35 and 35% of daily energy intake, and 10% from snacks. Dietary prescriptions followed the Swedish Nutrition Recommendations. All patients were encouraged to increase their level of physical activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-60 years
  • BMI > 30 kg/m2
  • speaking swedish

排除标准

  • eating disorder
  • unstable diabetes type 1
  • unstable cardiac disease
  • severe psychiatric disorder
  • pregnancy or lactation

结局指标

主要结局

Weight development

时间窗: 52 weeks

次要结局

  • Eating behaviour (Three Factor Eating Questionnaire)(52 weeks)

研究者

发起方
Göteborg University
申办方类型
Other

研究点 (1)

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