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临床试验/NCT01270451
NCT01270451已完成不适用

Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2008年9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
165
试验地点
2
主要终点
Weight regain

研究概览

简要总结

Primary Outcomes:

  1. To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
  2. To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.

Secondary Outcomes: 3. To study the association between vit.D levels and T2DM. 4. To study the association between weight change and QOL. 5. To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level. 6. To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group. 7. To search for biomarkers that can identify people at risk of increasing weight post surgery

详细描述

Expected weight loss after GBP is 60-80% of the overweight. GBP is effective therapy against the obesity-related disorders, including T2DM. Some subjects start gaining weight within 12-18 months after surgery. Weight gain may again increase the risk for developing obesity-related disorders. Previous studies have found a link between vitamin D deficiencies and T2DM. Vitamin D levels will be monitored during the intervention. Studies have shown that patients who underwent GBP experienced a dramatic improvement in quality of life(QOL). After reaching maximum weight loss, many will slowly gain weight. For some people that means a decrease in QOL. In order to prevent weight gain it may be useful to provide additional follow-ups. Participants are randomised into two groups: Group A will receive extra guidance and follow-up, while Group B will continue with the existing scheme. Participants in Group A will over the next 2 yrs take part in frequent meetings. To assess dietary habits, physical activity patterns and QOL, food diaries, physical activity questionnaires and QOL questionnaires are used. Anthropometric and blood pressure measurements will be taken and blood samples will be collected at regular time intervals before and during the study. The results will be used to validate the effect of extra guidance, and to decide if this treatment shall be offered to all of our patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients undergoing gastric bypass surgery at OUH in the period January 2006 to June 2009 (recruited 24 ± 9 months following surgery)
  • Willingness to participate at regular meetings at OUH

排除标准

  • Patients who have experienced serious complications due to the bariatric surgery
  • Patients who do not understand Norwegian
  • Immobile patients

研究组 & 干预措施

Lifestyle group counseling

Other

Included patients will be randomised into two groups: to the intervention group or to the control group.

干预措施: Lifestyle intervention to prevent weight regain (Other)

结局指标

主要结局

Weight regain

时间窗: 2 and 4 years postsurgery

次要结局

  • Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.(2 and 4 years postsurgery)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oslo University Hospital

Anne-Marie Aas

Oslo University Hospital

研究点 (2)

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