Does Use of the Voy Program Improve Weight Loss Percentage and Other Health Outcomes in a Population Already Taking GLP/GIP-1RA Medication?

Официальное название

A Decentralised Open Label Trial to eValuate the Efficacy Of the VoY Program in A Patient Population Using GLP/GIP-1RA thERapy

Обзор

The aim of the trial is to assess the impact of the Voy Program on weight loss and other health outcomes in an obese population already approved for GLP/GIP-1RA medication. If an eligible participant consents to take part in the trial, they will be randomly allocated into one of the two trial groups. One group will continue with the standard pathway for GLP/GIP-1RA as part of their usual care for weight loss, while the other group will utilise the Voy Program in addition to the standard pathway. In the intervention group, the Voy Program will include personalised sessions with a qualified coach as well as access to resources including managing nutrition and movement. The frequency of the coaching sessions will be led by the participant but will normally start fortnightly. All participants will be enrolled in the trial for 12 months and will be asked to complete questionnaires on a monthly and quarterly basis.

Подробное описание

This is a decentralised, single site, open label, parallel-group, superiority randomised controlled trial in participants with a BMI ≥30 (or BMI ≥27 with certain comorbidities) already offered GLP/GIP-1RA through Voy's standard pathway as part of their usual care for weight loss. A total of 470 eligible participants will be randomised in the UK to receive the standard pathway (GLP/GIP-1RA only - control arm), or the standard pathway (GLP/GIP-1RA) plus the Voy Program (intervention arm).

Screening, informed consent and eligibility assessments will occur online. Participants in the intervention group will receive coaching sessions via video and phone calls with a qualified coach. These sessions will be participant led but will normally initially occur fortnightly. Participants in the intervention arm will also have access to all available features in the Voy app, which is used to book coaching sessions and also includes content around nutrition and exercise management, weight progress tracking, and an AI-powered meal analysis tool to support behavioural changes. Participants will be expected to complete surveys monthly. Participants will enter data directly into the trial web platform, EDC platform or the sponsors platform (Voy). Participation in the initial trial is expected to last approximately 12 months, with optional long term follow-up continuing for an additional 12 months (24 months total).

Вмешательства

• Поведенческое Voy Program
  Voy Program - coaching and access to the Voy app to support behavioural changes

Первичные конечные точки

• Percentage weight loss Percentage weight loss [Срок оценки: Primary endpoint of 12 months; with data collected at Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]

Вторичные конечные точки (12)

• Absolute and percentage change in waist to height ratio [Срок оценки: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
• Absolute and percentage change in waist to hip ratio [Срок оценки: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
• Absolute and percentage change in Blood glucose (HbA1c) and CRP [Срок оценки: Baseline, Months 3, 6, 9, 12]
• Absolute and percentage change in Lipid profile (total cholesterol, LDL, HDL, triglycerides) [Срок оценки: Baseline, Months 3, 6, 9, 12]
• Absolute and percentage change in CRP [Срок оценки: Baseline, Months 3, 6, 9, 12]
• Change in blood pressure [Срок оценки: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
• Change in heart rate [Срок оценки: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]
• Change in Comorbidity status (i.e. new diagnosis) [Срок оценки: Baseline, Months 3, 6, 9, 12]
• Change in patient activation measured using the following validated questionnaire: Patient Activation Measure-10 (PAM-10) [Срок оценки: Baseline, Months 3, 6 9, 12]
• Change in quality of life measured using the following validated questionnaires: EQ-5D-5L [Срок оценки: Baseline, Months 3, 6 9, 12]
• Change in health and quality of life measured using the following unvalidated questionnaires: Voy's weight-related quality of life survey [Срок оценки: Baseline, Months 3, 6 9, 12]
• Changes in Body fat percentage measured via Renpho bluetooth scale [Срок оценки: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]

Критерии участия

Критерии включения

• Aged 18-65.
• BMI≥30,

a. Or BMI≥27 with any of the following comorbidities as diagnosed by a Doctor:

• High blood pressure
• High cholesterol
• Obstructive sleep apnoea
• Erectile dysfunction
• Asthma
• Osteoarthritis
• Chronic back pain
• PCOS
• Fatty liver disease
• Approved for the standard GLP/GIP-1RA pathway by Voy as part of usual care for weight loss.
• People who use either an iOS or Android smartphone using operating system iOS 16 or Android 8 or later.
• Agree to not use another intervention for weight loss for the duration of the trial.

• Other diet specific interventions such as meal replacement shakes.
• Over the counter medication / supplements such as appetite suppressants, thermogenics, herbal supplements.
• Any other medicated weight loss program.
• Structured weight loss programs such as Weight Watchers, Noom, Second Nature.
• Non-surgical medical weight management such as lipotropic injections and metabolic enhancers.
• Surgical interventions such as a gastric bypass, banding, or other bariatric surgery
• Other personalised nutrition programmes, such as ZOE
• Able and willing to provide Informed Consent and adhere to trial procedures.

Критерии исключения

• Pregnant or breastfeeding women, or those planning to get pregnant in the next 12 months.
• Known diabetes mellitus (Type 1 or 2) or thyroid disease.
• Previous surgery or endoscopic intervention for obesity, or planned surgery or endoscopic intervention for obesity in the next 12 months.
• Lost ≥ 5kg in the last 3 months intentionally or otherwise.
• Currently using other weight loss medications, or use of other weight loss medications in the past 6 months.
• Currently using medications that cause weight gain, including systemic steroids, or used such medications in the past 6 months.
• Severe anxiety or depression (either PHQ-9 >15 or GAD7 >10).
• Severe eating disorder (Binge eating scale ≥27).
• Participation in another interventional clinical study or use of investigational drugs in the last 6 months.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate 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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06710587 · LH-MAN-01 · 350648

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗