An interventional study of Voy Program in Obesity and Weight Loss, sponsored by Menwell Limited. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Menwell Limited · Not applicable, Interventional, and Supportive care
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.
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).
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 470 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Menwell Limited as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
BMI≥30,
a. Or BMI≥27 with any of the following comorbidities as diagnosed by a Doctor:
Agree to not use another intervention for weight loss for the duration of the trial.
Exclusion Criteria:
Standard GLP/GIP-1RA pathway as offered by Voy as part of participants usual care for weight loss
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
Behavioral: Voy Program
Voy Program - coaching and access to the Voy app to support behavioural changes
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
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
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
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
To evaluate the impact of the Voy Program on waist to hip ratio over 12 months
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
To evaluate the impact of the Voy Program on Metabolic parameters over 12 months
Time frame: 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
Time frame: 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
Time frame: Baseline, Months 3, 6, 9, 12
Change in blood pressure
To evaluate the impact of the Voy Program on Vital signs over 12 months
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
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
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
Time frame: 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
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)
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)
Time frame: 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)
Time frame: 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))
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)
To evaluate the impact of the Voy Program on eating disorders over 12 months (Higher scores indicate more Uncontrolled, Restraint and Emotional eating)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline, Months 3, 6 9, 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Apr 2026, 15 months later.
Of 98 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 15 months is close to that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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