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

NCT06710587 | Not Yet Recruiting

• 2 other identifiers: LH-MAN-01350648
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Weight Loss

Keywords

Voy Program

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Absolute and percentage change in waist to hip ratio

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Absolute and percentage change in Blood glucose (HbA1c) and CRP

  Baseline, Months 3, 6, 9, 12

• Absolute and percentage change in Lipid profile (total cholesterol, LDL, HDL, triglycerides)

  Baseline, Months 3, 6, 9, 12

• Absolute and percentage change in CRP

  Baseline, Months 3, 6, 9, 12

Study Arms (2)

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

Behavioral: Voy Program

Interventions

Voy Program BEHAVIORAL

Voy Program - coaching and access to the Voy app to support behavioural changes

Intervention - Standard Pathway + Voy Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65.
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Menwell Limited: lead
• Lindus Health: collaborator

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Carel Le Roux

  Ulster University

  PRINCIPAL INVESTIGATOR

• Werd Al-Najim

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Calvert

CONTACT

07308 312153; james.calvert@lindushealth.com

Tessa Griffiths

CONTACT

07308 312153; tessa@lindushealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, parallel-group, superiority randomised controlled trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: January 2, 2025
• Primary Completion: April 2, 2026
• Study Completion (Estimated): April 2, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share