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

Официальное название

Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3

Обзор

In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity.

Подробное описание

In the LightWAY trial, an intensive weight loss (IWL) intervention will be compared with with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:

* Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient. * Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required). * Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.

Usual care will differ between the two countries (Denmark and the United Kingdom).

In Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.

In the United Kingdom, participants are eligible for referral into an NHS Tier 3 weight management service. These services are commissioned by integrated care boards, and can therefore differ slightly across the 42 regions within the UK. These are specialist weight management clinics that provide non-surgical, intensive medical management with a multidisciplinary approach to care. These clinics often consist of specialist doctors, nurses, dieticians and physiotherapists/exercise therapists, and include psychological support.

Вмешательства

• Поведенческое Intensive weight loss intervention
  Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
• Поведенческое Usual care
  Usual care

Первичные конечные точки

• MetS-Z [Срок оценки: 104 weeks after randomisation]
• Weight [Срок оценки: 104 weeks after randomisation]

Вторичные конечные точки (3)

• Short-Form-36, mental component score [Срок оценки: 104 weeks after randomisation]
• Gait speed [Срок оценки: 104 weeks after randomisation]
• Weight loss (20%) [Срок оценки: 104 weeks after randomisation]

Критерии участия

Please note that participants need to be invited in order to take part in the trial

Критерии включения

• Age ≥18 years and ≤60 years old at screening.
• 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.
• Provides informed consent.

Критерии исключения

• Intending to become pregnant in the next two years or pregnant or breastfeeding.
• Use of WLM or GLP-1 agonist treatment within the last three months.
• Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• 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.
• Diagnosis of or treatment for severe eating disorder within the last 6 months.
• 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.
• Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
• Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
• Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
• Another member of the household enrolled in the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 9 центров

• University Hospitals Birmingham NHS Foundation Trust — Birmingham
• University Hospitals of Derby and Burton NHS Foundation Trust — Derby
• East of England RRDN — Ipswich
• Yorkshire and Humber RRDN (Leeds, Sheffield and Hull) — Leeds
• South West Peninsula RRDN — Plymouth
• Powys Teaching Health Board — Powys
• South Central RRDN — Southampton
• Torbay and South Devon NHS Trust — Torquay
• … и ещё 1 центр

Дания · 5 центров

• Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet — Frederiksberg
• The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg — Frederiksberg
• Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyg — Hvidovre
• The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager an — Hvidovre
• Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering — Søborg

Публикации

• Wane S, Aveyard P, Wielsoe S, Larsen SC, Scragg J, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bandholm T, Albury C, Overbeck G, Reventlow S, Olsen KR, Farr P, Bojsen-Moller KN, Heitmann BL, Waldorff FB, Madsbad S, Dirksen C, Jebb SA. Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial prot PMID 42161553

Идентификаторы

NCT: NCT06321458 · LightWAY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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