A Decentralised Open Label Trial to eValuate the Efficacy Of the VoY Program in A Patient Population Using GLP/GIP-1RA thERapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 470
- 主要终点
- Percentage weight loss Percentage weight loss
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Osteoarthritis
- •Chronic back pain
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage weight loss Percentage weight loss
时间窗: 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
次要结局
- 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)
- Change in blood pressure(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Change in heart rate(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Change in Comorbidity status (i.e. new diagnosis)(Baseline, Months 3, 6, 9, 12)
- Change in patient activation measured using the following validated questionnaire: Patient Activation Measure-10 (PAM-10)(Baseline, Months 3, 6 9, 12)
- Change in quality of life measured using the following validated questionnaires: EQ-5D-5L(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(Baseline, Months 3, 6 9, 12)
- Changes in Body fat percentage measured via Renpho bluetooth scale(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)(Baseline, Months 3, 6 9, 12)
- Changes in mental health using scores derived from validated questionnaire The Patient Health Questionnaire (PHQ-9)(Baseline, Months 3, 6 9, 12)
- Changes in eating disorders using scores derived from validated questionnaire Binge Eating Scale (BES)(Baseline, Months 3, 6 9, 12)
- Changes in eating disorders using scores derived from validated questionnaire The Three Factor Eating Questionnaire (TFEQ-R18)(Baseline, Months 3, 6 9, 12)
- Occurrence of (serious) adverse events.(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Cost-utility analysis on healthcare utilisation questionnaire(Baseline, Months 3, 6 9, 12)
- Maintenance of weight loss at 24 months(Month 24)
- Changes in diet quality(Baseline, Months 3, 6 9, 12)