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NOT YET RECRUITING

NCT06710587

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

Sponsor: Menwell Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

470

Start Date

2025-01-02

Completion Date

2027-04-02

Last Updated

2024-11-29

Healthy Volunteers

Conditions

Obesity Weight Loss

Interventions

BEHAVIORAL

Voy Program

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

Inclusion Criteria: 1. Aged 18-65. 2. 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 3. Approved for the standard GLP/GIP-1RA pathway by Voy as part of usual care for weight loss. 4. People who use either an iOS or Android smartphone using operating system iOS 16 or Android 8 or later. 5. 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 6. Able and willing to provide Informed Consent and adhere to trial procedures. Exclusion Criteria: 1. Pregnant or breastfeeding women, or those planning to get pregnant in the next 12 months. 2. Known diabetes mellitus (Type 1 or 2) or thyroid disease. 3. Previous surgery or endoscopic intervention for obesity, or planned surgery or endoscopic intervention for obesity in the next 12 months. 4. Lost ≥ 5kg in the last 3 months intentionally or otherwise. 5. Currently using other weight loss medications, or use of other weight loss medications in the past 6 months. 6. Currently using medications that cause weight gain, including systemic steroids, or used such medications in the past 6 months. 7. Severe anxiety or depression (either PHQ-9 \>15 or GAD7 \>10). 8. Severe eating disorder (Binge eating scale ≥27). 9. Participation in another interventional clinical study or use of investigational drugs in the last 6 months. 10. 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.