VOYAGER Trial

The VOYAGER Trial is trying to find out whether use of the Voy Program improves weight loss percentage and other health outcomes in a population already taking GLP/GIP-1RA medication.

We are inviting you to join this trial because you have been identified to have been approved for a GLP/GIP-1RA medication by Voy and may benefit from the Voy Program.

The Voy Program includes coaching sessions with a qualified coach via video call/phone as well as access to nutritional and exercise resources via the Voy smartphone application.

The trial will last a minimum of 12 months and you will be required to record your weight over this period, as well as answer questionnaires about your health and quality of life.

Study run by

Lindus Health

Who are Lindus Health

Lindus Health is a contract research organisation, which is a company that will run research studies on behalf of sponsors. Lindus is an experienced research company that will:

  • Manage the study following medical and ethical guidelines
  • Handle your information and track your participation
  • Collect data from participants
  • Ensure everything is done properly and safely

If you want to see more information about Lindus Health, please click on this link: https://www.lindushealth.com/ 

Sponsored by

Patrocinado por

Gesponsert von

Gesponsert von

Opdrachtgever:

Menwell LImited (Trading as Voy)

Participants

Participantes

Teilnehmenden

Deelnemers:

470

People

Personen

Participate by

Participar mediante

Abschlussdatum

Uiterlijke Inschrijving:

Who is the study for? 

Individuals who:

  • Participants must:
    • Be aged between 18-65
    • Be approved for a GLP/GIP-1RA medication by Voy
    • Have and be able to use a smartphone
  • Participants must NOT:
    • Have a diagnosis of type 1 or 2 diabetes or thyroid disease
    • (If female) Be pregnant or breastfeeding
    • Currently use other weight loss or weight gain medication, or have used in the past 6 months

What is expected of me? 

Here’s a step by step guide on what to expect:

  1. Pre-Eligibility Questionnaire & Consent (Onboarding Step 1 of 5)
  • On this page, you can review details of this trial and review the participant information sheet and informed consent form (linked below). You can then complete a questionnaire on this website to determine if you are potentially eligible for the study. If you pass this questionnaire you will be able to provide consent for trial participation if you choose.

  1. Screening Assessments (Onboarding Step 2 of 5)
  • Once you have consented you will be required to complete a set of questionnaires relating to your medical history, mental and physical health that further assess eligibility. 

  1. Screening Call (Onboarding Step 3 of 5)
  • If you are potentially eligible at this point, you will be invited to attend a screening call with our trial team. During this call, you will be provided with further study details, including information on the coaching program and study procedures. You will also have the opportunity to ask any questions you may have. 
  • The study team member will collect details surrounding current medications and medical history and confirm your eligibility for the trial.

  1. Baseline Assessments (Onboarding Step 4 of 5)
  • Once you have completed the call, you will be asked to complete a set of baseline assessments. You will complete a set of online questionnaires that ask you questions about your quality of life, your use of healthcare, mental and physical health. We will also collect data on your height, weight, waist/hip measurements, vital signs and from blood tests that are taken as part of your usual care by Voy.

  1. Randomisation (Onboarding Step 5 of 5)
  • Following completion of the baseline assessments, you will be randomly allocated into one of the two trial groups (control or intervention). 

  1. Treatment period:
  • Following randomisation, the intervention group participants will continue with GLP/GIP-1RA medication, and in addition have access to the Voy Program via the Voy app, and will be able to set up their first coaching session. Control participants will continue with the GLP/GIP-1RA medication only.
  • The trial period will last 12 months. All participants will be asked to complete assessments on a monthly and quarterly basis.

What is the benefit for me?

  • The intervention may or may not help you personally, but we hope this trial will help future people to receive the best evidence–based care. 
  • Taking part in the trial will mean you get a 35% reduction in the price you pay for your GLP/GIP-1RA medication every month that you are involved in the trial to compensate you for time spent on trial procedures. Additionally, if you complete all the questionnaires you will receive vouchers worth a total of £60.

VOYAGER Trial

The VOYAGER Trial is trying to find out whether use of the Voy Program improves weight loss percentage and other health outcomes in a population already taking GLP/GIP-1RA medication.

We are inviting you to join this trial because you have been identified to have been approved for a GLP/GIP-1RA medication by Voy and may benefit from the Voy Program.

The Voy Program includes coaching sessions with a qualified coach via video call/phone as well as access to nutritional and exercise resources via the Voy smartphone application.

The trial will last a minimum of 12 months and you will be required to record your weight over this period, as well as answer questionnaires about your health and quality of life.

Study run by

Lindus Health

Who are Lindus Health

Lindus Health is a contract research organisation, which is a company that will run research studies on behalf of sponsors. Lindus is an experienced research company that will:

  • Manage the study following medical and ethical guidelines
  • Handle your information and track your participation
  • Collect data from participants
  • Ensure everything is done properly and safely

If you want to see more information about Lindus Health, please click on this link: https://www.lindushealth.com/ 

Click here to take part
Haga clic aquí para participar
Teilnehmen
Klik hier om deel te nemen

Study for

Estudio dirigido a

Zielgrupper der Studie

Onderzoek voor:

People between 18-65 with obesity, defined as a BMI of ≥30, or a BMI of ≥27 with certain health conditions, that have been approved for treatment with a GLP/GIP-1RA medication by Voy as part of their routine care for weight loss.

Sponsored by

Patrocinado por

Gesponsert von

Opdrachtgever:

Menwell LImited (Trading as Voy)

Participants

Participantes

Teilnehmenden

Deelnemers:

470

People

Personen

Participate by

Participar mediante

Abschlussdatum

Duur van onderzoek:

Who is the study for? 

¿A quién va dirigido el estudio?

Für wen ist die Studie geeignet?

Voor wie is het onderzoek bedoeld?

Individuals who:

  • Participants must:
    • Be aged between 18-65
    • Be approved for a GLP/GIP-1RA medication by Voy
    • Have and be able to use a smartphone
  • Participants must NOT:
    • Have a diagnosis of type 1 or 2 diabetes or thyroid disease
    • (If female) Be pregnant or breastfeeding
    • Currently use other weight loss or weight gain medication, or have used in the past 6 months

What is expected of me? 

¿Qué se espera de mí?

Was wird von mir erwartet?

Wat wordt van mij verwacht?

Here’s a step by step guide on what to expect:

  1. Pre-Eligibility Questionnaire & Consent (Onboarding Step 1 of 5)
  • On this page, you can review details of this trial and review the participant information sheet and informed consent form (linked below). You can then complete a questionnaire on this website to determine if you are potentially eligible for the study. If you pass this questionnaire you will be able to provide consent for trial participation if you choose.

  1. Screening Assessments (Onboarding Step 2 of 5)
  • Once you have consented you will be required to complete a set of questionnaires relating to your medical history, mental and physical health that further assess eligibility. 

  1. Screening Call (Onboarding Step 3 of 5)
  • If you are potentially eligible at this point, you will be invited to attend a screening call with our trial team. During this call, you will be provided with further study details, including information on the coaching program and study procedures. You will also have the opportunity to ask any questions you may have. 
  • The study team member will collect details surrounding current medications and medical history and confirm your eligibility for the trial.

  1. Baseline Assessments (Onboarding Step 4 of 5)
  • Once you have completed the call, you will be asked to complete a set of baseline assessments. You will complete a set of online questionnaires that ask you questions about your quality of life, your use of healthcare, mental and physical health. We will also collect data on your height, weight, waist/hip measurements, vital signs and from blood tests that are taken as part of your usual care by Voy.

  1. Randomisation (Onboarding Step 5 of 5)
  • Following completion of the baseline assessments, you will be randomly allocated into one of the two trial groups (control or intervention). 

  1. Treatment period:
  • Following randomisation, the intervention group participants will continue with GLP/GIP-1RA medication, and in addition have access to the Voy Program via the Voy app, and will be able to set up their first coaching session. Control participants will continue with the GLP/GIP-1RA medication only.
  • The trial period will last 12 months. All participants will be asked to complete assessments on a monthly and quarterly basis.

Contact our study team
voyager@lindushealth.com

What is the benefit for me?

¿En qué me beneficia?

Welchen Nutzen habe ich davon?

Wat is het voordeel voor mij?

  • The intervention may or may not help you personally, but we hope this trial will help future people to receive the best evidence–based care. 
  • Taking part in the trial will mean you get a 35% reduction in the price you pay for your GLP/GIP-1RA medication every month that you are involved in the trial to compensate you for time spent on trial procedures. Additionally, if you complete all the questionnaires you will receive vouchers worth a total of £60.

Complete this questionnaire to take part.

Fülle diesen Fragebogen aus, um herauszufinden, ob Du berechtigt bist