Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

Launched by CARSTEN DIRKSEN · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new, intensive weight loss program designed for adults who have severe and complex obesity. The program includes total dietary replacements (which means participants will replace some meals with special diets), behavioral support to help change eating habits, and weight-loss medication. Researchers want to see how effective this program is compared to regular weight management options currently available through primary care doctors. They will also look at any potential risks and how cost-effective this new approach might be.

To participate in this trial, you must be between 18 and 60 years old and have a body mass index (BMI) above 35 or above 32.5 if you are from certain ethnic backgrounds and have related health issues like type 2 diabetes or high blood pressure. If selected, participants will receive support and guidance throughout the program. It’s important to know that if you are pregnant, breastfeeding, or have recently undergone certain medical treatments or surgeries, you may not be eligible. This trial is currently recruiting participants, so if you think you meet the criteria, you can find out more about joining.

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. Has severe and complex obesity i.e. BMI\>35 or \>32.5 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds and with one or more of these specific adiposity-related chronic diseases of cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea.
• • 3. Provides informed consent.
• Exclusion Criteria:
• • 1. Intending to become pregnant in the next two years or pregnant or breastfeeding.
• • 2. Use of WLM or GLP-1 agonist treatment within the last three months.
• • 3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• • 4. 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.
• • 5. Diagnosis of or treatment for severe eating disorder within the last 6 months.
• • 6. 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.
• • 7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
• • 8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
• • 9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
• • 10. Another member of the household enrolled in the trial.