DEMETRA - ADVICE-002-2022

NCT05394779 | Completed

• 1 other identifier: ADVICE-002-2022
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Health Behavior; Life Style; Dietary Habits; Weight Loss; Diet, Healthy; Diet Habit; Body Weight; Nutrition Disorders; Nutrition, Healthy; Overweight and Obesity; Behavioral Disorder

Keywords

Digital Therapeutics; Digital Medicine; Adherence; Software; Software Medical Device; Quality of life; Digital Therapy; Obesity; Exercise Program; Physical Activity; Diet; Nutritional Program; Psychological status

Outcome Measures

Primary Outcomes (1)

• Evaluation of change in body weight (kg)

  Change in absolute body weight (kg) at 6 months from baseline in obese DTXO users compared with obese Placebo App users

  6 months

Secondary Outcomes (5)

• Evaluation of changes in patients' diet adherence with Numerical Rating Scale (NRS) scale

  12 months

• Evaluation of changes in patients' diet enjoyment with Numerical Rating Scale (NRS) scale

  12 months

• Evaluation of changes in patients' satiety with Numerical Rating Scale (NRS) scale

  12 months

• Evaluation of changes in patients' physical activity with short physical performance battery assessment

  12 months

• Evaluation of changes in patients' psychological behavior Depression Anxiety Stress Scale (DASS-21) score ≥18

  12 months

Study Arms (2)

DTXO APP

EXPERIMENTAL

Patients randomized to Group A (experimental group) will be administered the Mediterranean based dietary program by means of App DTXO. The dietary program will be administered through the DTXO application. Each patient will select the assigned daily menu or the proposed alternatives; The dietary program is personalized according to the patients caloric intake needs and to their nutritional restrictions. Patients randomized to Group A (experimental group) will be administered the Physical activity program by means of App DTXO. The activity program will be administered through the DTXO application based on the individual's background fitness level. Patients randomized to Group A (experimental group) will be invited to follow a psycho-behavioral program to increase awareness of the behaviors and habits related to obesity, consisting of multimedia and educational content, self-assessment and dynamic exercises.

Device: DTXO APP

PLACEBO APP-Control group

PLACEBO COMPARATOR

Patients randomized in Group B (control group) will be delivered a dietary program, according to the current standard of care and will be printed on paper with the information on the Mediterranean diet and general educational content related to food. The control arm will also be equipped with a placebo App to ensure the patient's blindness to treatment allocation and there will be asked to the patient to complete weekly the Diet Adherence questionnaire. Patients randomized in Group B (control group) will be advised to perform regular physical activity and provided with educational material and some tips on physical activity; no formal plan will be provided, as currently done in standard clinical practice. Patients randomized in Group B (control group) will receive printed educational material with generic content and advice for self-help support and followed as per standard clinical practice. The placebo App will be used as a data entry tool for questionnaires.

Device: PLACEBO APP - Control group

Interventions

DTXO APP DEVICE

DTXO is an investigational therapeutic intervention (Digital Therapeutics - DTx) for obese patients, under clinical validation with a randomized and placebo-controlled clinical trial for confirmatory purposes. It 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 dietary/exercise and behavioral programs. The App integrates different non-pharmacological approaches, engaging the patient through monitoring of her/his non-vital parameters, monitoring of patient diet and exercise, monitoring of patient psychological status, prescription of exercise and diet in a weight-loss program.

DTXO APP

PLACEBO APP - Control group DEVICE

The placebo App will include only the non-medical modules of the digital therapy and has been introduced to make the experience of subjects in the control arm more similar to that of subjects in the experimental arm; moreover, data collection through the placebo app (questionnaires) will streamline the data collection process, avoiding manual data entry and reducing the possibility of entry errors.

PLACEBO APP-Control group

Eligibility Criteria

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

You may qualify if:

• Participants must be between 18 and 65 years of age, at the time of signing the informed consent.
• Male and Female.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
• BMI between 30.0 kg/m2 and 45 kg/m2 .
• Participants must own a mobile phone, be willing to use mobile Apps and this type of technology (technology-savvy) and download the App described in the protocol.
• Native speakers of Italian language or foreign subjects who have a full understanding of the Italian language, as the instructions and information for all health programs will only be given in Italian.

You may not qualify if:

• Heart failure (class \>II), ischemic attack or stroke within the previous 6 months to the planned date of randomization.
• History or current evidence of drug or alcohol abuse.
• Chronic kidney failure with GFR category \>G2 (ml/min/1.73 m2).
• Type 1 diabetes.
• Previous malignancy within the first 5 years.
• Active eating disorder or previous history of bulimia and anorexia nervosa, active severe binge-eating disorder.
• Psychiatric disorders not compensated or at risk of decompensation.
• Visual or vision impairments
• Secondary obesity related to endocrinopathies, genetic syndromes, hypothalamic lesions or neurological diseases and immobility.
• Concomitant advanced obesity disease.
• History of bariatric surgery in the previous 2 years or plans for bariatric surgery during the study period.
• Referred pain to lower limb joints (hip, knee, ankle) on the NRS ≥ 5.
• Weight loss ≥10% in the 6 months prior to the planned date of randomization.

Sponsors & Collaborators

• Advice Pharma Group srl: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

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• Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

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• Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

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• Bertoli S, Capodaglio P, Colosimo S, De Amicis RS, Gilardini L, Bruno A, Mambrini SP, Pietrabissa G, Cavaggioni L, Castelnuovo G, Piazzolla G. Effectiveness of a Digital Therapy on 6-Month Weight Loss in People With Obesity: The Digital Therapy to Promote Weight Loss in Patients With Obesity by Increasing Their Adherence to Treatment (DEMETRA) Randomized Clinical Trial. J Med Internet Res. 2025 Oct 21;27:e72054. doi: 10.2196/72054.

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Related Links

• Dupuy HJ. The Psychological general Well-Being (PGWB) Index. In: Assessment of Quality of Life in clinical trials of cardiovascular therapies. Edited by Wenger NK, Mattson ME, Furberg CD, Elinson J. Le Jacq Publishing 1984; Chap 9:170-183
• General Self-Efficacy Scale (GSE)
• Cotter E.W., Kelly N.R. (2016) Binge Eating Scale (BES). In: Wade T. (eds) Encyclopedia of Feeding and Eating Disorders. Springer, Singapore. https://doi.org/10.1007/978-981-287-087-2\_9-2
• Hunt SM, McKenna S: A British adaptation of the general Wellbeing Index: a new tool for clinical research. British J Med Economics 1992, 2:49-60
• Italian translations of the DASS.
• Lovibond, S.H. \& Lovibond, P.F. (1995). Manual for the Depression Anxiety \& Stress Scales. (2nd Ed.)Sydney: Psychology Foundation
• Mannocci A, Di Thiene D, Del Cimmuto A, Masala D, Boccia A, De Vito E, La Torre G. International Physical Activity Questionnaire: validation and assessment in an Italian sample. Ital J Public Health 2010; 7(4):369-76
• S.I.O. - A.D.I. "Standard Italiani per la Cura dell'Obesità S.I.O. - A.D.I. 2016 - 2017"
• SCL-90-R - Giunti Psychometrics
• SINU - società italiana di nutrizione umana. LARN: livelli di assunzione di rifereimento di nutrienti ed energia per la popolazione italiana, IV revisione, 2014
• World Health Organization (WHO) - WHO Guidelines on Physical Activity and Sedentary Behaviour. 2020

MeSH Terms

Conditions

Obesity; Health Behavior; Feeding Behavior; Weight Loss; Body Weight; Nutrition Disorders; Overweight; Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal; Body Weight Changes

Study Officials

• Alessandro Flavio Ferri

  Advice Pharma Grou S.r.l

  STUDY DIRECTOR

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: Prospective, multicenter, pragmatic, randomized, double-arm, placebo-controlled, parallel, single-blind study.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 27, 2022
• Study Start: August 23, 2022
• Primary Completion: December 18, 2023
• Study Completion: May 30, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)