Obesity
Conditions
Keywords
Overweight, Metabolic syndrome, Weight loss, Diet, Atherogenic index, Prediabetes
Brief summary
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat. The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
Detailed description
The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program. * Allocation: Randomized * Endpoint classification: Efficacy Study * Intervention Model: Parallel Assignment in 1:1 active to control allocation * The aim of the study is to recruit a total (i.e. across all 4 sites) of 200 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 10% this should generate a minimum of 90 active treatment and 90 control subjects. * Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject) * Data from all sites will be collated at the end of the studies and analysis will be performed on one data set. This protocol governs the activities at both the USA and NI/UK clinical sites.
Interventions
DEVICEVeSTAL
The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.
Sponsors
University of California, San Diego
University of Ulster
Exploristics
Compliance Solutions Ltd.
Neurovalens Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent 2. Body mass index BMI ≥ 27 kg/m2. 3. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test at screen and also just before each DXA scan. (As DXA involves a small dose of ionizing radiation). They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain). 4. 22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6) 5. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring. 6. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial. 7. Agreement not to start smoking tobacco or marijuana
Exclusion criteria
1. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions. 2. History of bariatric surgery, or gastric resection. 3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears. 4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). 5. Use of a non-invasive weight loss device (e.g. Modius) 6. Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable). 7. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly) 8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working). 9. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure. 10. Treatment with prescription weight-loss drug therapy in the 6 months before starting the study. 11. Tobacco smoking (including vaping) in the six months prior to starting and for the duration of the study. 12. Use of marijuana (smoking, vaping or in edible form) more than twice a month on average. 13. Known genetic cause of obesity (e.g., Prader-Willi Syndrome). 14. Body weight change of more than 20% in either direction within the previous year. 15. Physician-prescribed diet, and/ or current, active member of an organized weight loss program. 16. Diabetes mellitus (Types 1 & 2). 17. Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy) 18. Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months. 19. Regular use (more than twice a month) of anti-histamine medication within the last 6 months. 20. Use of oral or intravenous corticosteroid medication within 6 months of starting the study. 21. Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study. 22. Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable). 23. An active diagnosis of cancer. 24. A myocardial infarction within the preceding year. 25. A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation). 26. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.). 27. Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, eating disorder etc.) 28. Current participant in another weight loss study or other clinical trial. 29. Have a family member who is currently participating or is planning to participate in this study. 30. Weight over 350 pounds at UU, TDE and CTRI site (as this is the weight limit of the DXA scanner) or a weight over 500 pounds at the EPARC site (as this is the weight limit of the DXA scanner) 31. Pregnancy The decision to exclude participants with type 2 diabetes mellitus was made after reading the FDA's draft guidance (see: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071612.pdf). This notes that, \[c\]compared with nondiabetic patients, overweight and obese patients with type 2 diabetes often respond less favorably to weight-management products and may face unique safety issues such as risk for sulfonylurea-induced hypoglycemia following weight loss (if the dose of sulfonylurea is not appropriately lowered or the drug discontinued). The FDA then go on to advise examining the efficacy and safety of weight-management products in trials dedicated to patients with type 2 diabetes. On the basis of this advice we made the decision to exclude patients with type 2 diabetes. This is an important patient group of course, and our intention is to investigate type 2 diabetics in due course. If a subject is found to possibly have type 2 diabetes during the initial screening, then they will be excluded and asked to notify their primary care physician. However, if a subject passes the initial screening but a suspicion of this diagnosis arises during one of the study tests, then the subject will be asked to notify their primary care physician, though they will still be allowed to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of Weight From Baseline | From baseline to 6 months | The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device |
| Categorical: Proportion of Participants Who Lose 5% Total Body Weight | 6 months | The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Loss of Baseline Visceral Adipose Tissue | % change in VAT mass at 6 months | The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan). |
| Atherogenic Index | Absolute change from baseline to 6 months | The Atherogenic Index is calculated using the lipid profile by determining the ratio of Total Cholesterol (TC) to High-Density Lipoprotein (HDL) cholesterol. If the ratio has been transformed (e.g., natural log-transformed or log10), this will be explicitly stated in the analysis, and the Unit of Measure will reflect this transformation as log(ratio) or ln(ratio) accordingly. |
| Percentage Fat Loss | Percentage change from baseline to 6 months | Percentage fat loss from baseline. (As measured by means of a whole body DXA scan). |
| Total Energy Intake (kcal) | Change from baseline to 6 months | Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall. |
| Quality of Life Ratings | Absolute change from baseline to 6 months | Quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a validated self-report measure designed to assess obesity-specific quality of life in adults. Scores range from 0 to 100, with higher scores indicating better quality of life. The outcome measure reflects the absolute change in IWQOL-Lite total scores from baseline to 6 months (i.e., IWQOL-Lite score at 6 months minus IWQOL-Lite score at baseline). Results are reported as the mean absolute change with standard deviation for each study arm. |
| Systemic Inflammation | Percentage change from baseline to 6 months | Systemic inflammation is assessed using high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L). This outcome measure represents the percentage change in hs-CRP levels from baseline to 6 months. Higher or lower percentage changes indicate increases or decreases in systemic inflammation, respectively. Values are reported as the mean percentage change with standard deviation (SD) for each group. |
| Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | Absolute change at 3 months and 6 months | Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Baseline, Month 3, Month 6 (or other specified time points) | This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes. |
| Dose Response Analysis | Percentage Weight Loss from Baseline, by Treatment and Treatment Compliance at 3 months and 6 months | It is likely that some subjects will use their device more than other. Usage data will be available from the devices permitting a dose response analysis, which will done be in an intention to treat manner. Treatment Compliance =(Number of weeks with over 5 hours of total usage / Number weeks of device usage)\*100 High Treatment Compliance = Treatment Compliance \>75% Medium Treatment Compliance = Treatment Compliance \>=55% and \<=75% Low Treatment Compliance = Treatment Compliance \<55% |
| Hearing Loss Assessment | Baseline and 6 months | Hearing Loss (Judged to be abnormal, normal or missing by examining clinician by audiometry results). |
| Food Frequency Questionnaire | Baseline | This outcome measure evaluates nutrient intake based on responses from the Food Frequency Questionnaire (FFQ). The FFQ assesses the frequency of consumption of various food items, allowing for an estimation of intake for several nutrients, including energy (kcal), carbohydrates (g), free sugars (g), total sugars (g), starch (g), fat (g), saturated fat (g), protein (g), fiber (g), and alcohol (g). Participants report their typical consumption of foods and beverages, which is then used to estimate their average intake of these nutrients over a specified period. The data are reported in grams or kilocalories, as appropriate for each nutrient, and can be used to evaluate dietary patterns and nutrient consumption changes throughout the study. |
| Fat Intake | Baseline, 3-months and 6-months | Fat intake as assessed by 24 hour dietary recall. |
| Baseline Truncal Body Fat | Baseline | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. |
| Fiber | Baseline, 3-months and 6-months | Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire |
| Alcohol | Baseline, 3-month, and 6-month | This outcome measure assesses alcohol consumption (in grams) based on a two-day, 24-hour dietary recall. Participants were asked to recall their alcohol intake for two separate 24-hour periods, providing a comprehensive estimate of their usual consumption. The data is presented for baseline, 3-month, and 6-month time points, with values reported as the mean and standard deviation (SD). |
| Healthy Eating Index | 6 months | Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet. |
| Total Physical Activity in MET-hours Per Week | Baseline and 6 months | Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire |
| Saturated Fat Intake | Baseline, 3-months and 6-months | Saturated fat intake as assessed by 24 hour dietary recall. |
| Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Baseline, 3-months and 6-months | Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall |
| 6 Month Truncal Body Fat | 6 Month | This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study. |
| Difference in Bone Mineral Content | Absolute change from baseline to 6 months | Bone mineral content (BMC) was measured to assess changes in bone health. The outcome reflects the absolute change in BMC from baseline to 6 months (i.e., BMC at 6 months minus BMC at baseline). Results are reported as the mean absolute change with standard deviation (SD) for each study arm. The Unit of Measure is BMC (kg), consistent with the reported data. Higher values indicate greater BMC, while lower or negative values indicate reductions in BMC over time. |
| Fasting Glucose Change From Baseline | Change from Baseline to 6 months | Fasting glucose in mg/dL |
| Glycated Hemoglobin | Change from baseline to 6 months Change from baseline to 6 months Change from baseline to 6 months | This outcome measures the change in glycated hemoglobin (HbA1c) levels, reported as a percentage (%), from baseline to 6 months. HbA1c is a biomarker that reflects average blood glucose levels over the past 2-3 months and is commonly used to assess long-term glucose control. A reduction in HbA1c indicates improved blood sugar management. The change is calculated by subtracting the baseline value from the value at 6 months. |
| Blood Pressure | Baseline | This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point. |
| Heart Rate | Baseline and 6 months | Heart rate in beats per minute |
| Hip-waist Ratio | 6 months | Hip-waist ratio |
| Body Mass Index (BMI) | Baseline and 6 months | BMI in kg/m\^2 |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VeSTAL - Active Device The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. | 117 |
| Sham Device The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
VeSTAL: The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. | 124 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Joined another lifestyle program | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 6 |
| Overall Study | Medication change | 1 | 0 |
| Overall Study | Non-compliance | 4 | 10 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 10 |
Baseline characteristics
| Characteristic | Sham Device | Total | VeSTAL - Active Device |
|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 10.8 | 46.3 years STANDARD_DEVIATION 11.53 | 45.5 years STANDARD_DEVIATION 12.3 |
| Body Mass Index | 35.81 kg/m^2 STANDARD_DEVIATION 5.76 | 36.36 kg/m^2 STANDARD_DEVIATION 6.22 | 36.94 kg/m^2 STANDARD_DEVIATION 6.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) White | 95 Participants | 189 Participants | 94 Participants |
| Region of Enrollment United Kingdom | 48 participants | 94 participants | 46 participants |
| Region of Enrollment United States | 76 participants | 147 participants | 71 participants |
| Sex: Female, Male Female | 99 Participants | 198 Participants | 99 Participants |
| Sex: Female, Male Male | 25 Participants | 43 Participants | 18 Participants |
| Weight | 99.86 Kg STANDARD_DEVIATION 20.37 | 99.73 Kg STANDARD_DEVIATION 20.18 | 99.60 Kg STANDARD_DEVIATION 20.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 122 |
| other Total, other adverse events | 52 / 116 | 56 / 122 |
| serious Total, serious adverse events | 0 / 116 | 0 / 122 |
Outcome results
Primary
Categorical: Proportion of Participants Who Lose 5% Total Body Weight
The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control
Time frame: 6 months
Population: Unadjusted Intention to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VeSTAL - Active Device | Categorical: Proportion of Participants Who Lose 5% Total Body Weight | 25 Participants |
| Sham Device | Categorical: Proportion of Participants Who Lose 5% Total Body Weight | 25 Participants |
Primary
Percentage Change of Weight From Baseline
The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device
Time frame: From baseline to 6 months
Population: Unadjusted Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Percentage Change of Weight From Baseline | -2.46 Percentage change from baseline | Standard Deviation 4.766 |
| Sham Device | Percentage Change of Weight From Baseline | -1.97 Percentage change from baseline | Standard Deviation 4.971 |
Secondary
Atherogenic Index
The Atherogenic Index is calculated using the lipid profile by determining the ratio of Total Cholesterol (TC) to High-Density Lipoprotein (HDL) cholesterol. If the ratio has been transformed (e.g., natural log-transformed or log10), this will be explicitly stated in the analysis, and the Unit of Measure will reflect this transformation as log(ratio) or ln(ratio) accordingly.
Time frame: Absolute change from baseline to 6 months
Population: Unadjusted Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Atherogenic Index | -0.10 Atherogenic Index | Standard Deviation 0.66 |
| Sham Device | Atherogenic Index | -0.27 Atherogenic Index | Standard Deviation 0.454 |
Secondary
Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group
Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan).
Time frame: Absolute change at 3 months and 6 months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | 3 months | -0.107 Kg | Standard Deviation 2.1676 |
| VeSTAL - Active Device | Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | 6 months | -0.169 Kg | Standard Deviation 1.9577 |
| Sham Device | Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | 3 months | 0.990 Kg | Standard Deviation 1.3227 |
| Sham Device | Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group | 6 months | -0.078 Kg | Standard Deviation 1.811 |
Secondary
Mean Percent Loss of Baseline Visceral Adipose Tissue
The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan).
Time frame: % change in VAT mass at 6 months
Population: Unadjusted Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Mean Percent Loss of Baseline Visceral Adipose Tissue | -10.316 % change in VAT mass at 6 months | Standard Deviation 12.4607 |
| Sham Device | Mean Percent Loss of Baseline Visceral Adipose Tissue | -4.731 % change in VAT mass at 6 months | Standard Deviation 14.6057 |
Secondary
Percentage Fat Loss
Percentage fat loss from baseline. (As measured by means of a whole body DXA scan).
Time frame: Percentage change from baseline to 6 months
Population: Unadjusted Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Percentage Fat Loss | -5.268 Percentage change | Standard Deviation 8.1254 |
| Sham Device | Percentage Fat Loss | -3.638 Percentage change | Standard Deviation 9.1772 |
Secondary
Quality of Life Ratings
Quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a validated self-report measure designed to assess obesity-specific quality of life in adults. Scores range from 0 to 100, with higher scores indicating better quality of life. The outcome measure reflects the absolute change in IWQOL-Lite total scores from baseline to 6 months (i.e., IWQOL-Lite score at 6 months minus IWQOL-Lite score at baseline). Results are reported as the mean absolute change with standard deviation for each study arm.
Time frame: Absolute change from baseline to 6 months
Population: Adjusted Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Quality of Life Ratings | 7.71 IWQoL Total Score | Standard Deviation 12.193 |
| Sham Device | Quality of Life Ratings | 9.08 IWQoL Total Score | Standard Deviation 14.022 |
Secondary
Systemic Inflammation
Systemic inflammation is assessed using high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L). This outcome measure represents the percentage change in hs-CRP levels from baseline to 6 months. Higher or lower percentage changes indicate increases or decreases in systemic inflammation, respectively. Values are reported as the mean percentage change with standard deviation (SD) for each group.
Time frame: Percentage change from baseline to 6 months
Population: Unadjusted Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Systemic Inflammation | -0.51 % change mg/ml | Standard Deviation 5.645 |
| Sham Device | Systemic Inflammation | -0.31 % change mg/ml | Standard Deviation 1.845 |
Secondary
Total Energy Intake (kcal)
Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall.
Time frame: Change from baseline to 6 months
Population: Unadjusted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Total Energy Intake (kcal) | -241.56 kcal | Standard Deviation 703.82 |
| Sham Device | Total Energy Intake (kcal) | -180.39 kcal | Standard Deviation 1114.909 |
Other Pre-specified
6 Month Truncal Body Fat
This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study.
Time frame: 6 Month
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | 6 Month Truncal Body Fat | 19.082 Kg | Standard Deviation 4.1085 |
| Sham Device | 6 Month Truncal Body Fat | 20.008 Kg | Standard Deviation 4.5043 |
Other Pre-specified
Alcohol
This outcome measure assesses alcohol consumption (in grams) based on a two-day, 24-hour dietary recall. Participants were asked to recall their alcohol intake for two separate 24-hour periods, providing a comprehensive estimate of their usual consumption. The data is presented for baseline, 3-month, and 6-month time points, with values reported as the mean and standard deviation (SD).
Time frame: Baseline, 3-month, and 6-month
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Alcohol | Baseline | 23.67 grams | Standard Deviation 17.9 |
| VeSTAL - Active Device | Alcohol | Month 3 | 22.45 grams | Standard Deviation 17.948 |
| VeSTAL - Active Device | Alcohol | Month 6 | 25.02 grams | Standard Deviation 23.928 |
| Sham Device | Alcohol | Baseline | 26.38 grams | Standard Deviation 20.501 |
| Sham Device | Alcohol | Month 3 | 16.63 grams | Standard Deviation 11.682 |
| Sham Device | Alcohol | Month 6 | 21.63 grams | Standard Deviation 20.519 |
Other Pre-specified
Baseline Truncal Body Fat
This outcome measure assesses the amount of body fat located in the trunk or torso region at baseline. Truncal body fat includes both visceral and subcutaneous fat around the abdomen, chest, and back. It is typically measured using a whole-body DXA scan, which provides an accurate assessment of fat distribution. The baseline value is recorded before any intervention or treatment to serve as a reference point for evaluating changes in truncal body fat over the course of the study.
Time frame: Baseline
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Baseline Truncal Body Fat | 25.209 Kg | Standard Deviation 8.452 |
| Sham Device | Baseline Truncal Body Fat | 24.393 Kg | Standard Deviation 7.4186 |
Other Pre-specified
Blood Pressure
This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point.
Time frame: 6 Months
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Blood Pressure | 85.6 mmHg | Standard Deviation 11.46 |
| Sham Device | Blood Pressure | 81.3 mmHg | Standard Deviation 8.89 |
Other Pre-specified
Blood Pressure
This outcome measures the change in diastolic blood pressure (measured in mmHg). Diastolic blood pressure was assessed using standard clinical methods at each time point.
Time frame: Baseline
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Blood Pressure | 85.4 mmHg | Standard Deviation 11.07 |
| Sham Device | Blood Pressure | 82.0 mmHg | Standard Deviation 10.1 |
Other Pre-specified
Body Mass Index (BMI)
BMI in kg/m\^2
Time frame: Baseline and 6 months
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Body Mass Index (BMI) | 6 months | 36.6 kg/m^2 | Standard Deviation 6.94 |
| VeSTAL - Active Device | Body Mass Index (BMI) | Baseline | 36.9 kg/m^2 | Standard Deviation 6.68 |
| Sham Device | Body Mass Index (BMI) | 6 months | 34.8 kg/m^2 | Standard Deviation 6.25 |
| Sham Device | Body Mass Index (BMI) | Baseline | 35.9 kg/m^2 | Standard Deviation 5.78 |
Other Pre-specified
Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars
Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall
Time frame: Baseline, 3-months and 6-months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Baseline | 191.68 grams | Standard Deviation 79.983 |
| VeSTAL - Active Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Month 3 | 170.88 grams | Standard Deviation 64.303 |
| VeSTAL - Active Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Month 6 | 158.55 grams | Standard Deviation 69.894 |
| Sham Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Baseline | 188.01 grams | Standard Deviation 84.253 |
| Sham Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Month 3 | 165.94 grams | Standard Deviation 66.797 |
| Sham Device | Carbohydrate; Starchy Carbohydrates, Sugars, and Free Sugars | Month 6 | 178.29 grams | Standard Deviation 159.162 |
Other Pre-specified
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality
This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes.
Time frame: Baseline, Month 3, Month 6 (or other specified time points)
Population: ITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Not reported | 60 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Medication knwon ro cause weight gain | 34 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Medication known to cause weight loss | 23 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Not reported | 53 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Medication knwon ro cause weight gain | 42 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Medication known to cause weight loss | 29 Participants |
Other Pre-specified
Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality
This outcome measure tracks the use of concomitant medications during the study, focusing on adjustments in cardiovascular medications and the presence of medications known to influence weight. For cardiovascular medications, data include any increases, decreases, or no changes in medication use, as well as instances where information is not applicable (N/A). The assessment also includes the categorization of medications known to cause weight gain or weight loss, reporting the number of participants using such medications. This allows for an understanding of how changes in cardiovascular treatments and the use of weight-altering medications may interact with study outcomes.
Time frame: Baseline, Month 3, Month 6 (or other specified time points)
Population: ITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Decrease in cardiovascular medication | 1 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | N/A | 1 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | No change in cardiovascular medication | 24 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Not reported | 89 Participants |
| VeSTAL - Active Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Increase in cardiovascular medication | 2 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Not reported | 89 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Increase in cardiovascular medication | 4 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | Decrease in cardiovascular medication | 3 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | No change in cardiovascular medication | 28 Participants |
| Sham Device | Concomitant Medication: Cardiovascular Adjustments and Weight Gain Causality | N/A | 0 Participants |
Other Pre-specified
Difference in Bone Mineral Content
Bone mineral content (BMC) was measured to assess changes in bone health. The outcome reflects the absolute change in BMC from baseline to 6 months (i.e., BMC at 6 months minus BMC at baseline). Results are reported as the mean absolute change with standard deviation (SD) for each study arm. The Unit of Measure is BMC (kg), consistent with the reported data. Higher values indicate greater BMC, while lower or negative values indicate reductions in BMC over time.
Time frame: Absolute change from baseline to 6 months
Population: Unadjusted Intention to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Difference in Bone Mineral Content | 0.003 BMC (kg) | Standard Deviation 0.0645 |
| Sham Device | Difference in Bone Mineral Content | -0.001 BMC (kg) | Standard Deviation 0.0504 |
Other Pre-specified
Dose Response Analysis
It is likely that some subjects will use their device more than other. Usage data will be available from the devices permitting a dose response analysis, which will done be in an intention to treat manner. Treatment Compliance =(Number of weeks with over 5 hours of total usage / Number weeks of device usage)\*100 High Treatment Compliance = Treatment Compliance \>75% Medium Treatment Compliance = Treatment Compliance \>=55% and \<=75% Low Treatment Compliance = Treatment Compliance \<55%
Time frame: Percentage Weight Loss from Baseline, by Treatment and Treatment Compliance at 3 months and 6 months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Dose Response Analysis | Month 3 High | -2.60 % weight loss | Standard Deviation 3.105 |
| VeSTAL - Active Device | Dose Response Analysis | Month 3 Medium | -2.48 % weight loss | Standard Deviation 2.825 |
| VeSTAL - Active Device | Dose Response Analysis | Month 3 Low | -1.79 % weight loss | Standard Deviation 3.06 |
| VeSTAL - Active Device | Dose Response Analysis | Month 6 High | -4.26 % weight loss | Standard Deviation 4.07 |
| VeSTAL - Active Device | Dose Response Analysis | Month 6 Medium | -3.64 % weight loss | Standard Deviation 3.49 |
| VeSTAL - Active Device | Dose Response Analysis | Month 6 Low | -1.46 % weight loss | Standard Deviation 4.32 |
| Sham Device | Dose Response Analysis | Month 6 Medium | -1.24 % weight loss | Standard Deviation 5.407 |
| Sham Device | Dose Response Analysis | Month 3 High | -3.51 % weight loss | Standard Deviation 3.951 |
| Sham Device | Dose Response Analysis | Month 6 High | -4.73 % weight loss | Standard Deviation 5.223 |
| Sham Device | Dose Response Analysis | Month 3 Medium | -1.38 % weight loss | Standard Deviation 3.276 |
| Sham Device | Dose Response Analysis | Month 6 Low | -1.00 % weight loss | Standard Deviation 4.073 |
| Sham Device | Dose Response Analysis | Month 3 Low | -0.84 % weight loss | Standard Deviation 2.939 |
Other Pre-specified
Fasting Glucose Change From Baseline
Fasting glucose in mg/dL
Time frame: Change from Baseline to 6 months
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Fasting Glucose Change From Baseline | 0.798 mg/dl | Standard Deviation 10.9941 |
| Sham Device | Fasting Glucose Change From Baseline | 0.164 mg/dl | Standard Deviation 6.8325 |
Other Pre-specified
Fat Intake
Fat intake as assessed by 24 hour dietary recall.
Time frame: Baseline, 3-months and 6-months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Fat Intake | Baseline | 78.73 Fat (g) | Standard Deviation 38.935 |
| VeSTAL - Active Device | Fat Intake | Month 3 | 66.15 Fat (g) | Standard Deviation 25.57 |
| VeSTAL - Active Device | Fat Intake | Month 6 | 71.89 Fat (g) | Standard Deviation 28.724 |
| Sham Device | Fat Intake | Baseline | 78.51 Fat (g) | Standard Deviation 37.884 |
| Sham Device | Fat Intake | Month 3 | 67.08 Fat (g) | Standard Deviation 32.377 |
| Sham Device | Fat Intake | Month 6 | 72.87 Fat (g) | Standard Deviation 68.834 |
Other Pre-specified
Fiber
Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
Time frame: Baseline, 3-months and 6-months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Fiber | Month 3 | 19.79 grams | Standard Deviation 7.938 |
| VeSTAL - Active Device | Fiber | Baseline | 19.31 grams | Standard Deviation 7.831 |
| VeSTAL - Active Device | Fiber | Month 6 | 18.25 grams | Standard Deviation 6.57 |
| Sham Device | Fiber | Baseline | 19.54 grams | Standard Deviation 8.989 |
| Sham Device | Fiber | Month 3 | 18.61 grams | Standard Deviation 9.378 |
| Sham Device | Fiber | Month 6 | 18.62 grams | Standard Deviation 9.227 |
Other Pre-specified
Food Frequency Questionnaire
This outcome measure evaluates nutrient intake based on responses from the Food Frequency Questionnaire (FFQ). The FFQ assesses the frequency of consumption of various food items, allowing for an estimation of intake for several nutrients, including energy (kcal), carbohydrates (g), free sugars (g), total sugars (g), starch (g), fat (g), saturated fat (g), protein (g), fiber (g), and alcohol (g). Participants report their typical consumption of foods and beverages, which is then used to estimate their average intake of these nutrients over a specified period. The data are reported in grams or kilocalories, as appropriate for each nutrient, and can be used to evaluate dietary patterns and nutrient consumption changes throughout the study.
Time frame: Baseline
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Food Frequency Questionnaire | Carbohydrate | 230.95 grams | Standard Deviation 128.239 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Saturated Fat | 46.55 grams | Standard Deviation 26.98 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Sugars | 122.17 grams | Standard Deviation 79.046 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Protein | 130.21 grams | Standard Deviation 46.945 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Free sugars | 62.97 grams | Standard Deviation 53.947 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Fibre | 28.48 grams | Standard Deviation 22.071 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Starch | 99.92 grams | Standard Deviation 61.226 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Alcohol | 5.3 grams | Standard Deviation 8.302 |
| VeSTAL - Active Device | Food Frequency Questionnaire | Fat | 117.40 grams | Standard Deviation 58.807 |
| Sham Device | Food Frequency Questionnaire | Alcohol | 5.41 grams | Standard Deviation 9.922 |
| Sham Device | Food Frequency Questionnaire | Fat | 113.19 grams | Standard Deviation 70.277 |
| Sham Device | Food Frequency Questionnaire | Carbohydrate | 234.69 grams | Standard Deviation 171.041 |
| Sham Device | Food Frequency Questionnaire | Free sugars | 65.86 grams | Standard Deviation 80.208 |
| Sham Device | Food Frequency Questionnaire | Sugars | 130.20 grams | Standard Deviation 104.795 |
| Sham Device | Food Frequency Questionnaire | Starch | 96.03 grams | Standard Deviation 67.388 |
| Sham Device | Food Frequency Questionnaire | Saturated Fat | 43.76 grams | Standard Deviation 32.643 |
| Sham Device | Food Frequency Questionnaire | Protein | 124.81 grams | Standard Deviation 61.433 |
| Sham Device | Food Frequency Questionnaire | Fibre | 29.69 grams | Standard Deviation 15.287 |
Other Pre-specified
Glycated Hemoglobin
This outcome measures the change in glycated hemoglobin (HbA1c) levels, reported as a percentage (%), from baseline to 6 months. HbA1c is a biomarker that reflects average blood glucose levels over the past 2-3 months and is commonly used to assess long-term glucose control. A reduction in HbA1c indicates improved blood sugar management. The change is calculated by subtracting the baseline value from the value at 6 months.
Time frame: Change from baseline to 6 months Change from baseline to 6 months Change from baseline to 6 months
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VeSTAL - Active Device | Glycated Hemoglobin | -0.148 percentage of HbA1c | Standard Deviation 0.8657 |
| Sham Device | Glycated Hemoglobin | -0.004 percentage of HbA1c | Standard Deviation 0.2166 |
Other Pre-specified
Healthy Eating Index
Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet.
Time frame: 6 months
Other Pre-specified
Hearing Loss Assessment
Hearing Loss (Judged to be abnormal, normal or missing by examining clinician by audiometry results).
Time frame: Baseline and 6 months
Population: Safety analysis set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VeSTAL - Active Device | Hearing Loss Assessment | Baseline | Abnormal | 7 Participants |
| VeSTAL - Active Device | Hearing Loss Assessment | Baseline | Missing | 0 Participants |
| VeSTAL - Active Device | Hearing Loss Assessment | Month 6 | Missing | 37 Participants |
| VeSTAL - Active Device | Hearing Loss Assessment | Month 6 | Abnormal | 6 Participants |
| VeSTAL - Active Device | Hearing Loss Assessment | Baseline | Normal | 109 Participants |
| VeSTAL - Active Device | Hearing Loss Assessment | Month 6 | Normal | 73 Participants |
| Sham Device | Hearing Loss Assessment | Month 6 | Missing | 42 Participants |
| Sham Device | Hearing Loss Assessment | Month 6 | Normal | 77 Participants |
| Sham Device | Hearing Loss Assessment | Baseline | Abnormal | 3 Participants |
| Sham Device | Hearing Loss Assessment | Baseline | Normal | 119 Participants |
| Sham Device | Hearing Loss Assessment | Baseline | Missing | 0 Participants |
| Sham Device | Hearing Loss Assessment | Month 6 | Abnormal | 3 Participants |
Other Pre-specified
Heart Rate
Heart rate in beats per minute
Time frame: Baseline and 6 months
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Heart Rate | Baseline | 70.8 bpm | Standard Deviation 9.99 |
| VeSTAL - Active Device | Heart Rate | 6 months | 71.1 bpm | Standard Deviation 10.29 |
| Sham Device | Heart Rate | Baseline | 69.6 bpm | Standard Deviation 10.14 |
| Sham Device | Heart Rate | 6 months | 68.6 bpm | Standard Deviation 10.66 |
Other Pre-specified
Hip-waist Ratio
Hip-waist ratio
Time frame: 6 months
Population: Data not analysed
Other Pre-specified
Saturated Fat Intake
Saturated fat intake as assessed by 24 hour dietary recall.
Time frame: Baseline, 3-months and 6-months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Saturated Fat Intake | Baseline | 26.11 Saturated Fat (g) | Standard Deviation 14.82 |
| VeSTAL - Active Device | Saturated Fat Intake | Month 3 | 22.33 Saturated Fat (g) | Standard Deviation 12.765 |
| VeSTAL - Active Device | Saturated Fat Intake | Month 6 | 24.73 Saturated Fat (g) | Standard Deviation 12.761 |
| Sham Device | Saturated Fat Intake | Baseline | 27.16 Saturated Fat (g) | Standard Deviation 15.163 |
| Sham Device | Saturated Fat Intake | Month 3 | 22.23 Saturated Fat (g) | Standard Deviation 12.678 |
| Sham Device | Saturated Fat Intake | Month 6 | 25.97 Saturated Fat (g) | Standard Deviation 28.76 |
Other Pre-specified
Total Physical Activity in MET-hours Per Week
Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire
Time frame: Baseline and 6 months
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VeSTAL - Active Device | Total Physical Activity in MET-hours Per Week | Baseline | 57.19 MWET-hours/Week | Standard Deviation 83.99 |
| VeSTAL - Active Device | Total Physical Activity in MET-hours Per Week | Month 6 | 41.19 MWET-hours/Week | Standard Deviation 53.354 |
| Sham Device | Total Physical Activity in MET-hours Per Week | Baseline | 43.17 MWET-hours/Week | Standard Deviation 58.502 |
| Sham Device | Total Physical Activity in MET-hours Per Week | Month 6 | 41.85 MWET-hours/Week | Standard Deviation 57.977 |