Doctor referral of overweight people to low energy treatment: the DROPLET trial

Not Applicable

Completed

• Conditions: Obesity in adults; Nutritional, Metabolic, Endocrine; Obesity due to excess calories

• Registration Number: ISRCTN75092026
• Lead Sponsor: niversity of Oxford

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-19
• Study Completion: 2018-01-01
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean body weight from baseline to 12 months.