ObesityVOYAGERNCT06710587
Does Use of the Voy Program Improve Weight Loss Percentage and Other Health Outcomes in a Population Already Taking GLP/GIP-1RA Medication?
A study testing Voy Program in people with Obesity and Weight Loss, run by Menwell Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Voy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2025to 2 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65.
- BMI≥30,
- Or BMI≥27 with any of the following comorbidities as diagnosed by a Doctor:
- High blood pressure
- High cholesterol
- Obstructive sleep apnoea
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Decentralised Open Label Trial to eValuate the Efficacy Of the VoY Program in A Patient Population Using GLP/GIP-1RA thERapy
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.
Read more
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.
Read the 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
- Being tested
- Voy Program
- Keywords
- Voy Program
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voy ProgramBehavioural
Voy Program - coaching and access to the Voy app to support behavioural changes
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard Pathway | No intervention | Standard GLP/GIP-1RA pathway as offered by Voy as part of participants usual care for weight loss |
| Intervention - Standard Pathway + Voy Program | Experimental | Standard GLP/GIP-1RA pathway as offered by Voy as part of participants usual care for weight loss + Voy Program - coaching and access to the Voy app to support behavioural changes Receives: Behavioral: Voy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage weight loss Percentage weight loss
To evaluate and draw inferences on the percentage weight loss in participants prescribed GLP/GIP-1RA therapy with and without the Manual Voy Program
Measured: Primary endpoint of 12 months; with data collected at Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes (20)
Absolute and percentage change in waist to height ratio
To evaluate the impact of the Voy Program on waist to height ratio over 12 months
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Absolute and percentage change in waist to hip ratio
To evaluate the impact of the Voy Program on waist to hip ratio over 12 months
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Absolute and percentage change in Blood glucose (HbA1c) and CRP
To evaluate the impact of the Voy Program on Metabolic parameters over 12 months
Measured: Baseline, Months 3, 6, 9, 12
Absolute and percentage change in Lipid profile (total cholesterol, LDL, HDL, triglycerides)
To evaluate the impact of the Voy Program on Metabolic parameters over 12 months
Measured: Baseline, Months 3, 6, 9, 12
Absolute and percentage change in CRP
To evaluate the impact of the Voy Program on Metabolic parameters over 12 months
Measured: Baseline, Months 3, 6, 9, 12
Change in blood pressure
To evaluate the impact of the Voy Program on Vital signs over 12 months
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change in heart rate
To evaluate the impact of the Voy Program on Vital signs over 12 months
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change in Comorbidity status (i.e. new diagnosis)
To evaluate the impact of the Voy Program on the status of obesity-related comorbidities at 12 months, such as hypertension, dyslipidemia and progression to raised / abnormal HbA1C
Measured: Baseline, Months 3, 6, 9, 12
Change in patient activation measured using the following validated questionnaire: Patient Activation Measure-10 (PAM-10)
To evaluate the impact of the Voy Program on Patient Activation 12 months - a higher score = a higher activation level (0-100)
Measured: Baseline, Months 3, 6 9, 12
Change in quality of life measured using the following validated questionnaires: EQ-5D-5L
To evaluate the impact of the Voy Program on Quality of life at 12 months (level 1-5 with 1 being no problems and 5 being extreme problems)
Measured: 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
To evaluate the impact of the Voy Program on Quality of life at 12 months - questions use 5-part likert scale with 1 being no problems/never, and 5 being lots of problems/always
Measured: Baseline, Months 3, 6 9, 12
Changes in Body fat percentage measured via Renpho bluetooth scale
To evaluate the impact of the Voy Program on Body fat percentage over 12 months
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Changes in anxiety using scores derived from validated questionnaire Generalised Anxiety Disorder-7 item (GAD-7)
To evaluate the impact of the Voy Program on anxiety over 12 months (The cut-off points for mild, moderate, and severe anxiety are 5, 10, and 15, respectively)
Measured: Baseline, Months 3, 6 9, 12
Changes in mental health using scores derived from validated questionnaire The Patient Health Questionnaire (PHQ-9)
To evaluate the impact of the Voy Program on mental health over 12 months (The PHQ-9 score ranges from 0 to 27, with the following ranges indicating the severity of depression:
0-4: None or minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression)
Measured: Baseline, Months 3, 6 9, 12
Changes in eating disorders using scores derived from validated questionnaire Binge Eating Scale (BES)
To evaluate the impact of the Voy Program on eating disorders over 12 months (no binge eating (score ≤ 17), mild to moderate binge eating (score of 18 - 26) and severe binge eating (score ≥ 27))
Measured: Baseline, Months 3, 6 9, 12
Changes in eating disorders using scores derived from validated questionnaire The Three Factor Eating Questionnaire (TFEQ-R18)
To evaluate the impact of the Voy Program on eating disorders over 12 months (Higher scores indicate more Uncontrolled, Restraint and Emotional eating)
Measured: Baseline, Months 3, 6 9, 12
Occurrence of (serious) adverse events.
To evaluate the impact of the Voy Program on occurrence of (S)AEs throughout the trial
Measured: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Cost-utility analysis on healthcare utilisation questionnaire
To evaluate the impact of the Voy Program on Health Economic Outcomes and productivity over 12 months
Measured: Baseline, Months 3, 6 9, 12
Maintenance of weight loss at 24 months
To evaluate the impact of the Voy Program on long-term outcomes (weight loss maintenance) over 24 months
Measured: Month 24
Changes in diet quality
Changes in diet quality using scores derived from the following validated questionnaire: Rapid Prime Diet Quality Score Screener (rPDQS) - (scoring is a traffic light logic system (green= healthy dietary pattern; yellow = less healthy dietary pattern; red = unhealthy dietary pattern), assigning 0 points for red, 1 for yellow, and 2 for green-coded frequency of food group consumption, with a potential range of 0 to 26)
Measured: Baseline, Months 3, 6 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, parallel-group, superiority randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menwell Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Carel Le Roux, Principal investigator, Ulster UniversityWerd Al-Najim, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710587
- Sponsor's protocol ID
- LH-MAN-01
- Other IDs
- 350648
- Acronym
- VOYAGER
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralised Open Label Trial to eValuate the Efficacy Of the VoY Program in A Patient Population Using GLP/GIP-1RA thERapy
- ClinicalTrials.gov ID
- NCT06710587
- Acronym / sponsor ID
- VOYAGER / LH-MAN-01
- Conditions
- Obesity, Weight Loss
- Keywords
- Voy Program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Menwell LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, parallel-group, superiority randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control - Standard Pathway | No intervention | –Standard GLP/GIP-1RA pathway as offered by Voy as part of participants usual care for weight loss |
| Intervention - Standard Pathway + Voy Program | Experimental | Behavioral: Voy ProgramStandard GLP/GIP-1RA pathway as offered by Voy as part of participants usual care for weight loss + Voy Program - coaching and access to the Voy app to support behavioural changes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Aged 18-65.
- BMI≥30,
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voy ProgramVoy Program - coaching and access to the Voy app to support behavioural changes | Behavioural | Intervention - Standard Pathway + Voy Program |
Primary outcome
Percentage weight loss Percentage weight loss
Time frame: Primary endpoint of 12 months; with data collected at Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
To evaluate and draw inferences on the percentage weight loss in participants prescribed GLP/GIP-1RA therapy with and without the Manual Voy Program
20 secondary outcomes
Absolute and percentage change in waist to height ratio
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Absolute and percentage change in waist to hip ratio
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Absolute and percentage change in Blood glucose (HbA1c) and CRP
Time frame: Baseline, Months 3, 6, 9, 12
Absolute and percentage change in Lipid profile (total cholesterol, LDL, HDL, triglycerides)
Time frame: Baseline, Months 3, 6, 9, 12
Absolute and percentage change in CRP
Time frame: Baseline, Months 3, 6, 9, 12
Change in blood pressure
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change in heart rate
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change in Comorbidity status (i.e. new diagnosis)
Time frame: Baseline, Months 3, 6, 9, 12
Change in patient activation measured using the following validated questionnaire: Patient Activation Measure-10 (PAM-10)
Time frame: Baseline, Months 3, 6 9, 12
Change in quality of life measured using the following validated questionnaires: EQ-5D-5L
Time frame: 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
Time frame: Baseline, Months 3, 6 9, 12
Changes in Body fat percentage measured via Renpho bluetooth scale
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Changes in anxiety using scores derived from validated questionnaire Generalised Anxiety Disorder-7 item (GAD-7)
Time frame: Baseline, Months 3, 6 9, 12
Changes in mental health using scores derived from validated questionnaire The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, Months 3, 6 9, 12
Changes in eating disorders using scores derived from validated questionnaire Binge Eating Scale (BES)
Time frame: Baseline, Months 3, 6 9, 12
Changes in eating disorders using scores derived from validated questionnaire The Three Factor Eating Questionnaire (TFEQ-R18)
Time frame: Baseline, Months 3, 6 9, 12
Occurrence of (serious) adverse events.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Cost-utility analysis on healthcare utilisation questionnaire
Time frame: Baseline, Months 3, 6 9, 12
Maintenance of weight loss at 24 months
Time frame: Month 24
Changes in diet quality
Time frame: Baseline, Months 3, 6 9, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carel Le Roux principal investigator
Ulster University
Werd Al-Najim principal investigator
Ulster University
Questions about this trial
What is this clinical trial studying?
A study testing Voy Program in people with Obesity and Weight Loss, run by Menwell Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Calvert (07308 312153, james.calvert@lindushealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage weight loss Percentage weight loss (time frame: Primary endpoint of 12 months; with data collected at Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.