NCT06710587

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Menwell Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Obesity
• Weight Loss

Interventions

Type	Name	Description
BEHAVIORAL	Voy Program	Voy Program - coaching and access to the Voy app to support behavioural changes

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-04-02
• Completion: 2027-04-02
• First posted: 2024-11-29
• Last updated: 2024-11-29