Clinical trial NCT06710587: Does Use of the Voy Program Improve Weight Loss Percentage and Other Health Outcomes in a Population Already Taking GLP/GIP-1RA Medication?
Official title: A Decentralised Open Label Trial to eValuate the Efficacy Of the VoY Program in A Patient Population Using GLP/GIP-1RA thERapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Voy Program
Lead sponsor: Menwell Limited
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2024-11-29
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, parallel-group, superiority randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

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.

Primary outcomes:
measure: Percentage weight loss Percentage weight loss
timeFrame: 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:
measure: Absolute and percentage change in waist to height ratio
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Absolute and percentage change in waist to hip ratio
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Absolute and percentage change in Blood glucose (HbA1c) and CRP
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Absolute and percentage change in Lipid profile (total cholesterol, LDL, HDL, triglycerides)
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Absolute and percentage change in CRP
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in blood pressure
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Change in heart rate
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Change in Comorbidity status (i.e. new diagnosis)
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in patient activation measured using the following validated questionnaire: Patient Activation Measure-10 (PAM-10)
timeFrame: Baseline, Months 3, 6 9, 12
measure: Change in quality of life measured using the following validated questionnaires: EQ-5D-5L
timeFrame: Baseline, Months 3, 6 9, 12
measure: Change in health and quality of life measured using the following unvalidated questionnaires: Voy's weight-related quality of life survey
timeFrame: Baseline, Months 3, 6 9, 12
measure: Changes in Body fat percentage measured via Renpho bluetooth scale
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Changes in anxiety using scores derived from validated questionnaire Generalised Anxiety Disorder-7 item (GAD-7)
timeFrame: Baseline, Months 3, 6 9, 12
measure: Changes in mental health using scores derived from validated questionnaire The Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Months 3, 6 9, 12
measure: Changes in eating disorders using scores derived from validated questionnaire Binge Eating Scale (BES)
timeFrame: Baseline, Months 3, 6 9, 12
measure: Changes in eating disorders using scores derived from validated questionnaire The Three Factor Eating Questionnaire (TFEQ-R18)
timeFrame: Baseline, Months 3, 6 9, 12
measure: Occurrence of (serious) adverse events.
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Cost-utility analysis on healthcare utilisation questionnaire
timeFrame: Baseline, Months 3, 6 9, 12
measure: Maintenance of weight loss at 24 months
timeFrame: Month 24
measure: Changes in diet quality
timeFrame: Baseline, Months 3, 6 9, 12
Other outcomes:
Locations:
Study officials:
affiliation: Ulster University
name: Carel Le Roux
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulster University
name: Werd Al-Najim
role: PRINCIPAL_INVESTIGATOR
References: