Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity

Launched by CARSTEN DIRKSEN · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well an intensive weight loss program works for adults with obesity compared to standard weight management options usually offered in primary care. The intensive program includes a special diet, support for changing eating habits, and weight-loss medications. Researchers want to find out if this approach is better for health and if it makes sense financially compared to the usual care.

To participate in the trial, you need to be between 18 and 60 years old and have a body mass index (BMI) of 30 or higher (or 27.5 or higher if you're from certain ethnic backgrounds). However, some people may not be eligible, such as those with serious obesity-related health issues or certain medical conditions. If you join the trial, you can expect to receive support and guidance throughout the weight loss process, and your progress will be monitored closely. It's important to note that participants need to be invited to take part in this study.

Gender

ALL

Eligibility criteria

• • Please note that participants need to be invited in order to take part in the trial.
• Inclusion Criteria:
• • 1. Age ≥18 years and ≤60 years old at screening.
• • 2. BMI ≥30 kg/m2 or ≥27.5 kg/m2 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds (as reported by the participants).
• • 3. Informed consent.
• Exclusion Criteria:
• • 1. Has severe and complex obesity, i.e., obesity class II (BMI≥35 if white or 32.5 if non-white) with one or more of these specific adiposity-related comorbidities: cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea (Appendix 1).
• • 2. Intending to become pregnant in the next two years, or pregnant, or breastfeeding.
• • 3. Use of WLM or GLP-1 agonist treatment within the last 3 months.
• • 4. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• • 5. Prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \>1 year before screening.
• • 6. Diagnosis or treatment for eating disorder within the last 6 months.
• • 7. Any other disease that markedly compromises the participant's ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person's length or quality of life, such as conditions limiting life expectancy.
• • 8. Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring any insulin therapy, phenylketonuria, or other conditions requiring special diets).
• • 9. Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial.
• • 10. Conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis)
• • 11. Another member of the household enrolled in the trial.