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临床试验/NCT01685957
NCT01685957已完成不适用

Optimal Dietary Treatment of Obese Adults

Hospitalsenheden Vest2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Body weight

研究概览

简要总结

Recent decades have shown an alarming increase in obesity. Obesity is associated with high costs for both the individual and for society. It is therefore important to prevent and treat obesity. The investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. However, this has not yet been studied. Since it will require more resources, it is important to investigate whether it also works better before changing the current treatment.

Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. There is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet.

Secondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Waist: female ≥ 88 cm; male ≥ 102 cm)
  • Stable weight for the past three month (+- 5 kilogram)
  • Motivated to make changes in their dietary habits

排除标准

  • Waist > 150 cm
  • Significant cardiovascular, renal or endocrine disease
  • Psychiatric history
  • Treatment with steroids
  • Alcohol- or drug-addiction
  • Pregnancy or lactation
  • Obesity surgery

研究组 & 干预措施

Standard dietary treatment (STD)

Active Comparator

Dietary treatment - 6 individual sessions with a registered dietitian

干预措施: Standard dietary treatment (STD) (Behavioral)

"Ned i vaegt" (NIV)

Experimental

Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

干预措施: "Ned i vaegt" (NIV) (Behavioral)

"Verdens bedste kur" (VBK)

Experimental

Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.

干预措施: "Verdens bedste kur" (VBK) (Behavioral)

结局指标

主要结局

Body weight

时间窗: From week 0 to week 52

次要结局

  • Dietary intake(From week 0 to week 52)
  • Blood pressure(From week 0 to week 52)
  • Dexa-scan (body composition)(From week 0 to week 52)
  • Waist circumference(From week 0 to week 52)
  • Biomarkers in blood samples(From week 0 to week 52)
  • Quality of life(From week 0 to week 52)

研究者

发起方
Hospitalsenheden Vest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Allan Stubbe Christensen

MHSc, RD

Hospitalsenheden Vest

研究点 (2)

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