Obesity in adults Nutritional, Metabolic, Endocrine Obesity due to excess calories
Conditions
Interventions
Participants are allocated to one of two groups:
1. GP referral to a low energy total diet replacement programme
2. Standard care for weight management offered by primary care providers
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean body weight from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 15/12/2016: 1. Change in mean weight between baseline, 3 and 6 months 2. Proportion of participants achieveing 5 and 10% weight loss at 12 months 2. Change in mean fat mass between baseline and 12 months 3. Change in mean low-density lipoprotein (LDL) cholesterol between baseline and 12 months 4. Change in mean HbA1c between baseline and 12 months 5. Change in mean systolic and diastolic blood pressure between baseline and 12 months Original secondary outcome measures: 1. Change in mean weight between baseline, 12 and 26 weeks. 2. Change in mean fat mass between baseline and 12, 26 and 52 weeks. 3. Change in mean low-density lipoprotein (LDL) cholesterol between baseline and 52 weeks 4. Change in mean HOMA IR (insulin resistance) between baseline and 52 weeks 5. Change in mean systolic and diastolic blood pressure between baseline and 12 weeks, 26 weeks and 52 weeks. 6. Change in the SF-12 physical functioning scale between baseline and 52 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed