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

Launched by MENWELL LIMITED · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether the Voy Program can help people who are already taking GLP/GIP-1RA medication lose more weight and improve their overall health. Participants in the trial will be divided into two groups: one group will continue with their usual care for weight loss, while the other group will use the Voy Program, which includes personalized coaching sessions and resources to help with nutrition and physical activity.

To join the trial, participants need to be between the ages of 18 and 65, have a body mass index (BMI) of 30 or higher (or 27 or higher with certain health conditions), and be approved for the GLP/GIP-1RA pathway for weight loss. Participants will be involved for 12 months and will answer questionnaires regularly to track their progress. It's important to know that those who are pregnant, have certain medical conditions like diabetes, or have recently lost a significant amount of weight won't be eligible to participate.

Gender

ALL

Eligibility criteria

• 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.