ISRCTN75092026已完成未知
A randomised controlled trial of a low energy diet treatment compared with usual care for weight management in primary care
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 270
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28780559 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30257983 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30801983 results (added 18/12/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32295605 results (added 17/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33827433/ exploratory results (added 09/04/2021) 2020 Results article in https://doi.org/10.1371/journal.pone.0238645 descriptive qualitative study (added 14/06/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37019430/ Secondary analysis (added 22/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or female, 18 years and older.
- •3. Body Mass Index =30 kg/m2
- •4. Likely to benefit from weight loss in the GP’s opinion
排除标准
- •Eclusion criteria as of 15/12/2016:
- •1. Unable to understand English
- •2. Currently or recently (within 3 months of study entry) attended a weight management programme, currently participating in another weight loss study
- •3. Had bariatric surgery, or scheduled to have bariatric surgery
- •4. Breastfeeding, pregnant or planning to become pregnant during the course of the study.
- •5. Receiving insulin therapy
- •6. Heart attack or stroke within the last 3 months,
- •7. Heart failure of grade II New York Heart Association and more severe,
- •8. Angina, arrhythmia including atrial fibrillation or prolonged QT syndrome.
- •9. Taking MAOI medication
- •10. Taking anticouagulant medication (e.g. warfarin)
- •11. Taking varenicline (smoking cessation medication)
- •12. Chronic renal failure of stage 4 or 5
- •13. Active liver disease except fatty liver or anyone with a past history of hepatoma or within 6 months of onset of acute hepatitis.
- •14. People having active treatment for cancer other than skin cancer treated with curative intent by local treatment only, or people taking hormonal or other long-term secondary prevention treatment after initial cancer treatment.
- •15. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer. (Maintenance treatment with acid-suppression is not a contraindication.)
- •16. Porphyria
- •17. Scheduled for surgery within 1 year
- •18. Any member of household is already enrolled in the study
- •19. Unwilling to provide blood samples
- •10. Patients that the GP judges not able to meet the demands of either treatment programme or measurement schedule. This may include severe medical problems not listed above or severe psychiatric problems including substance misuse that make following the treatment programme or adhering to the protocol unlikely.
- •Original exclusion criteria:
- •1. Unable to understand English
- •2. Currently or recently (within 3 months of study entry) attended a weight management programme, currently participating in another weight loss study or ever had bariatric surgery.
- •3. Breastfeeding, pregnant or planning to become pregnant during the course of the study.
- •4. Receiving insulin therapy
- •5. Heart attack or stroke within the last 3 months, heart failure of grade II New York Heart Association and more severe, or prolonged QT syndrome.
- •6. MAOI medication
- •7. Chronic renal failure of stage 4 or 5
- •8. Active liver disease except fatty liver or anyone with a past history of hepatoma or within 6 months of onset of acute hepatitis.
- •9. People having active treatment for cancer other than skin cancer treated with curative intent by local treatment only, or people taking hormonal or other long-term secondary prevention treatment after initial cancer treatment.
- •10. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer. Maintenance treatment with acid-suppression is not a contraindication.
- •11. Porphyria
- •12. Scheduled or on a waiting list for surgery within 1 year
- •13. Any member of household is already enrolled in the study
- •14. Unwilling to provide blood samples
- •15. Patients that the GP judges not able to meet the demands of either treatment programme or measurement schedule. This may include severe medical problems not listed above or severe psychiatric problems including substance misuse that make following the treatment programme or adhering to the protocol unlikely.
研究者
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