Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394779
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-05-05
Brief Title:
DEMETRA - ADVICE-002-2022
Sponsor:
Advice Pharma Group srl
Organization:
Advice Pharma Group srl
Study Overview
Official Title:
Evaluation of Performance and Safety of DTXO App an Innovative Digital Therapy in Improving Weight Loss and Weight-Loss Maintenance of Patients With Obesity by Increasing Their Adherence to Dietary Exercise Regimens and Psycho-Behavioral Program
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and performance of DTXO App in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental non-pharmacological treatment program The App will include a dietary plan and customized advice program a customized physical exercise program plan a cognitive- behavioral assessment and support program alerts and reminders on prescribed drugs intake and on dietary and exercise program chat and online visits with clinical professionals and trophies to improve patient engagement
Detailed Description:
DTXO is a medical device designed to deliver digital therapy intervention DTx to patients The DT as part of Digital Health utilizes high quality digital technologies to stimulate lifestyle changes in patients DTXO has been set up to improve the commitment of patients in following therapeutic directives ie nutritional programs dailyweekly physical activities to manage the disease of obesity Moreover DTXO can improve patients awareness about patients disease obesity so is intended to improve weight loss weight-loss maintenance and overall health in patients with obesity by increasing their self-engagement self-monitoring and adherence to dietaryexercise and behavioral programs In this prospective multicenter pragmatic randomized double-arm placebo-controlled parallel single-blind study the App integrates different non-pharmacological approaches engaging the patient through monitoring of patients non-vital parameters monitoring of patient diet and exercise monitoring of patient psychological status prescription of exercise and diet in a weight-loss program and configurable data presentation charts for provision of additional information to professional users
The aim of this study is to monitor patients non-vital parameters through data collection through patient-reported information data collection through coupled devices data processing by a proprietary algorithm based on clinical guidelines and data visualization by a proprietary interface AND Prescribe diet exercise and psycho-behavioral support intended for weight loss in obese patients
The dietary will be a personalized hypocaloric Mediterranean-based dietary program according to sex ages must be between 18 and 65 years of age physical activity level dietary preferences and eating habits and prescribed by the nutritionist physician at baseline V0 which aims at decreasing weight in obese patients and favoring patients compliance and adherence to the diet And regardless of the randomization arm all patients enrolled in the study will be invited by the investigator to follow a dietary program with a daily caloric intake kilocaloriesday or kcalday assigned by a standardized method with a fixed caloric deficit equal to 800 kcal drawn on the suggested values range from 500 to 1000 kcal
Specifically the caloric intake is classified starting from the measure of the daily Basal Metabolic Rate BMR based on genders male female weight height and age measured at baseline V0
The study will enroll 246 subjects both genders to obtain 172 overall valuable subjects 86 for each group The recruitment period will last 4 months Each patient will be followed for 12 months after baseline during which lifestyle changes will be implemented withwithout DTXO Regular follow-up visits are foreseen at 3 months 15 days V1 6 months 15 days V2 9 months 15 days V3 and 12 months 15 days V4 after enrollment in the end of the study is defined as the date of the last scheduled procedure shown in the Schedule of Activities for the last participant in the study globally
At the beginning of the study patients will be evaluated for their body mass index BMIweightheight2 that according with the literature patients with BMI 45 kgm2 are in a severe condition that requires a combination of pharmacological and surgical treatment with lifestyle intervention and are therefore excluded from the study The experimental arm will be compared with a control arm in which dietary and exercise programs will be delivered according to the current standard of care which foresees respectively a standard paper-based approach and clinical recommendations The control arm will also be equipped with a placebo App to ensure the patients blindness to treatment allocation
BenefitRisk Assessment Benefits for patients resulting from study implementation is the possibility to provide simultaneous treatment strategies to improve the health status of obese patients The expected result is that the simultaneous application of these strategies and the possibility of customizing patients activities based on their habits and feedback will allow greater benefits than the application of separate non-customized programs and a standard paper-based in-person approach For this the composite primary objectiveendpoint consists of easily measurable objective markers
Both treatment arms will receive potential benefits by participating in this study The control arm will receive the current standard of care paper-based approach and face-to-face follow-up visits for obese patients with the addition of a placebo app However greater benefits are hypothesized in the experimental arm due to the possibility of customization of physical activity in accordance with the perceptions and feedbacks of the patient the availability of notifications and reminders for drug intake dosage frequency to improve treatment adherence the availability of contents to support and favor compliance with the prescribed diet the possibility to schedule an online visit or communicate with the clinical specialist via chat through the App and the availability of multimedia psycho-behavioral content motivational exercises self-acceptance exercises mindfulness exercises interactive emotional eating exercises self-efficacy exercise
The main clinical benefit is improved weight loss and the overall health status of obese patients through the prescription of dietary and exercise programs delivered by a mobile App
Possible risks that can be anticipated in patients in the experimental arm are obsessive feeling about exercise and food intake and anxietyguilt when not reaching assigned exercise or food intake goals and interferences with subjects daily activities andor social life to the higher pressure to adhere to the programs given by the DTXO App compared to the standard of care approach
Primary Objective - To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 6 months of DTXO use
Secondary Objectives
1 To describe the primary objective in each randomized group
2 To stratify the primary objective results by sex
3 To stratify the primary objective results by ranges of BMI a baseline
4 To evaluate the effect on weight-loss maintenance according to weight loss reached at 6 months in patients using DTXO compared to patients not-provided after 12 months of DTXO use
5 To assess the percentage weight loss in each randomized group during the study
6 To assess differences in physical function improvements between the two randomized groups during the study
7 To assess the percentage weight loss between the two randomized groups during the study
8 To assess the body fat distribution changes in each randomized group during the study
9 To assess differences in body fat distribution changes between the two randomized groups during the study
10 To stratify the percentage weight-loss changes by ranges of BMI at baseline
11 To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 12 months of DTXO use
12 To assess the degree of physical inactivity reduction IPAQ Questionnaire in each randomized group during the study
13 To assess the degree of stress reduction DASS-21 scale in each randomized group during the study
14 To assess differences in the increase of quality of life PGWBI questionnaire between the two randomized groups during the study
Safety 15 To describe the safety profile in the two treatment groups
Primary Endpoints
- To evaluate the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to obese Placebo App users
Safety Endpoint To assess the rate of adverse events adverse device effects abnormality of laboratory parameters between the two randomized groups across the study V1 V2 V3 V4
Statistical Hypotheses This study is designed to test the null hypothesis that the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to the obese placebo control group is equal to zero The alternative hypothesis is that absolute body weight kg change between groups is less than zero
Sample Size Determination The sample size is estimated to provide statistical power for the primary endpoint The sample size was computed according to the primary endpoint namely the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to the obese placebo control group
Based on the primary endpoint the statistical analysis determined that a total sample size of 172 patients 86 per group would allow us 80 power and a two-sided type I error of 005 to detect a 15 kg difference in weight change at 6 months between the groups assuming an SD of 35 kg For this reasons the goal is to enrolled 246 patients to account for a dropout rate of 30
Data Quality Assurance All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically eg laboratory data The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must permit study-related monitoring audits Institutional Review BoardEthic Committee review and regulatory agency inspections and provide direct access to source data documents
The sponsor or designee is responsible for the data management of this study including quality checking of the data
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorized site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH International Conference on Harmonization GCP Good Clinical Practice and all applicable regulatory requirements
The aim of this study is to monitor patients non-vital parameters through data collection through patient-reported information data collection through coupled devices data processing by a proprietary algorithm based on clinical guidelines and data visualization by a proprietary interface AND Prescribe diet exercise and psycho-behavioral support intended for weight loss in obese patients
The dietary will be a personalized hypocaloric Mediterranean-based dietary program according to sex ages must be between 18 and 65 years of age physical activity level dietary preferences and eating habits and prescribed by the nutritionist physician at baseline V0 which aims at decreasing weight in obese patients and favoring patients compliance and adherence to the diet And regardless of the randomization arm all patients enrolled in the study will be invited by the investigator to follow a dietary program with a daily caloric intake kilocaloriesday or kcalday assigned by a standardized method with a fixed caloric deficit equal to 800 kcal drawn on the suggested values range from 500 to 1000 kcal
Specifically the caloric intake is classified starting from the measure of the daily Basal Metabolic Rate BMR based on genders male female weight height and age measured at baseline V0
The study will enroll 246 subjects both genders to obtain 172 overall valuable subjects 86 for each group The recruitment period will last 4 months Each patient will be followed for 12 months after baseline during which lifestyle changes will be implemented withwithout DTXO Regular follow-up visits are foreseen at 3 months 15 days V1 6 months 15 days V2 9 months 15 days V3 and 12 months 15 days V4 after enrollment in the end of the study is defined as the date of the last scheduled procedure shown in the Schedule of Activities for the last participant in the study globally
At the beginning of the study patients will be evaluated for their body mass index BMIweightheight2 that according with the literature patients with BMI 45 kgm2 are in a severe condition that requires a combination of pharmacological and surgical treatment with lifestyle intervention and are therefore excluded from the study The experimental arm will be compared with a control arm in which dietary and exercise programs will be delivered according to the current standard of care which foresees respectively a standard paper-based approach and clinical recommendations The control arm will also be equipped with a placebo App to ensure the patients blindness to treatment allocation
BenefitRisk Assessment Benefits for patients resulting from study implementation is the possibility to provide simultaneous treatment strategies to improve the health status of obese patients The expected result is that the simultaneous application of these strategies and the possibility of customizing patients activities based on their habits and feedback will allow greater benefits than the application of separate non-customized programs and a standard paper-based in-person approach For this the composite primary objectiveendpoint consists of easily measurable objective markers
Both treatment arms will receive potential benefits by participating in this study The control arm will receive the current standard of care paper-based approach and face-to-face follow-up visits for obese patients with the addition of a placebo app However greater benefits are hypothesized in the experimental arm due to the possibility of customization of physical activity in accordance with the perceptions and feedbacks of the patient the availability of notifications and reminders for drug intake dosage frequency to improve treatment adherence the availability of contents to support and favor compliance with the prescribed diet the possibility to schedule an online visit or communicate with the clinical specialist via chat through the App and the availability of multimedia psycho-behavioral content motivational exercises self-acceptance exercises mindfulness exercises interactive emotional eating exercises self-efficacy exercise
The main clinical benefit is improved weight loss and the overall health status of obese patients through the prescription of dietary and exercise programs delivered by a mobile App
Possible risks that can be anticipated in patients in the experimental arm are obsessive feeling about exercise and food intake and anxietyguilt when not reaching assigned exercise or food intake goals and interferences with subjects daily activities andor social life to the higher pressure to adhere to the programs given by the DTXO App compared to the standard of care approach
Primary Objective - To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 6 months of DTXO use
Secondary Objectives
1 To describe the primary objective in each randomized group
2 To stratify the primary objective results by sex
3 To stratify the primary objective results by ranges of BMI a baseline
4 To evaluate the effect on weight-loss maintenance according to weight loss reached at 6 months in patients using DTXO compared to patients not-provided after 12 months of DTXO use
5 To assess the percentage weight loss in each randomized group during the study
6 To assess differences in physical function improvements between the two randomized groups during the study
7 To assess the percentage weight loss between the two randomized groups during the study
8 To assess the body fat distribution changes in each randomized group during the study
9 To assess differences in body fat distribution changes between the two randomized groups during the study
10 To stratify the percentage weight-loss changes by ranges of BMI at baseline
11 To evaluate the effect on weight loss in patients using DTXO compared to patients not-provided after 12 months of DTXO use
12 To assess the degree of physical inactivity reduction IPAQ Questionnaire in each randomized group during the study
13 To assess the degree of stress reduction DASS-21 scale in each randomized group during the study
14 To assess differences in the increase of quality of life PGWBI questionnaire between the two randomized groups during the study
Safety 15 To describe the safety profile in the two treatment groups
Primary Endpoints
- To evaluate the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to obese Placebo App users
Safety Endpoint To assess the rate of adverse events adverse device effects abnormality of laboratory parameters between the two randomized groups across the study V1 V2 V3 V4
Statistical Hypotheses This study is designed to test the null hypothesis that the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to the obese placebo control group is equal to zero The alternative hypothesis is that absolute body weight kg change between groups is less than zero
Sample Size Determination The sample size is estimated to provide statistical power for the primary endpoint The sample size was computed according to the primary endpoint namely the change in absolute body weight kg at 6 months V2 from baseline V0 in obese DTXO users compared to the obese placebo control group
Based on the primary endpoint the statistical analysis determined that a total sample size of 172 patients 86 per group would allow us 80 power and a two-sided type I error of 005 to detect a 15 kg difference in weight change at 6 months between the groups assuming an SD of 35 kg For this reasons the goal is to enrolled 246 patients to account for a dropout rate of 30
Data Quality Assurance All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically eg laboratory data The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must permit study-related monitoring audits Institutional Review BoardEthic Committee review and regulatory agency inspections and provide direct access to source data documents
The sponsor or designee is responsible for the data management of this study including quality checking of the data
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorized site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH International Conference on Harmonization GCP Good Clinical Practice and all applicable regulatory requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None