Ramona De Amicis
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Ramona De Amicis has a total of 295 co-authors. Here are the top co-authors by number of shared publications:
- Alessandro Leone
Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, Milano, Italy
37 shared publications - Simona Bertoli
Obesity Unit and Laboratory of Nutrition and Obesity Research, Department of Endocrine and Metabolic Diseases, IRCCS Istituto Auxologico Italiano, 20145 Milan, Italy
37 shared publications - Alberto Battezzati
Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, Milano, Italy
24 shared publications - Andrea Foppiani
International Center for the Assessment of Nutritional Status and the Development of Dietary Intervention Strategies (ICANS-DIS), Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, 20133 Milan, Italy
20 shared publications Alberto Battezzati
International Center for the Assessment of Nutritional Status and the Development of Dietary Intervention Strategies (ICANS-DIS), Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, Milan, Italy
18 shared publicationsSimona Bertoli
15 shared publications
Latest Publications
- Open Access
Do’s and Don’ts in Mealtime Management for People with Oropharyngeal Dysphagia: A Modified Delphi Consensus Study from the Italian Society of Deglutology
Background: Meals are central to daily life, health, and social participation, yet their safety and enjoyment can be compromised in people with oropharyngeal dysphagia (OD). Despite the broad impact of OD on physical and psychosocial well-being and daily functioning, structured guidance for comprehensive mealtime management in clinical practice is lacking. To address this gap, a set of expert consensus-based “Do’s and Don’ts” covering four meal-related domains was developed. Methods: A modified Delphi consensus study promoted by the Italian Society of Deglutology involved a multidisciplinary panel of 53 experts in OD and related disciplines. Experts developed “Do” and “Don’t” statements across four domains: nutrition-focused diet prescription, meal preparation, mealtime experience, and patient and caregiver education. After panel conveners’ review, 61 statements underwent two rounds of online voting using a 3-point ordinal scale plus an additional option ‘unable to express an opinion’. Consensus was predefined as ≥75% agreement. Statements were revised between rounds based on participants’ comments to ensure clinical accuracy and practical applicability. Results: The response rate was 85% for Round 1 and 97.8% for Round 2. After Round 2, 57 of 61 statements (93.4%) reached the consensus threshold (≥75% agreement). Conclusions: Mealtime management in OD should be individualized and person-centered, balancing swallowing safety, nutritional requirements, quality of life, and enjoyment of eating. Management should extend beyond compensatory strategies alone to include the social and relational dimensions of meals. Active involvement and education of patients and caregivers are essential to support therapeutic adherence and daily implementation of recommendations. Interprofessional collaboration and multimodal educational strategies are crucial to ensuring a coordinated, safe, and effective nutritional approach to OD care.
Open AccessDo’s and Don’ts in Mealtime Management for People with Oropharyngeal Dysphagia: A Modified Delphi Consensus Study from the Italian Society of Deglutology
Background: Meals are central to daily life, health, and social participation, yet their safety and enjoyment can be compromised in people with oropharyngeal dysphagia (OD). Despite the broad impact of OD on physical and psychosocial well-being and daily functioning, structured guidance for comprehensive mealtime management in clinical practice is lacking. To address this gap, a set of expert consensus-based “Do’s and Don’ts” covering four meal-related domains was developed. Methods: A modified Delphi consensus study promoted by the Italian Society of Deglutology involved a multidisciplinary panel of 53 experts in OD and related disciplines. Experts developed “Do” and “Don’t” statements across four domains: nutrition-focused diet prescription, meal preparation, mealtime experience, and patient and caregiver education. After panel conveners’ review, 61 statements underwent two rounds of online voting using a 3-point ordinal scale plus an additional option ‘unable to express an opinion’. Consensus was predefined as ≥75% agreement. Statements were revised between rounds based on participants’ comments to ensure clinical accuracy and practical applicability. Results: The response rate was 85% for Round 1 and 97.8% for Round 2. After Round 2, 57 of 61 statements (93.4%) reached the consensus threshold (≥75% agreement). Conclusions: Mealtime management in OD should be individualized and person-centered, balancing swallowing safety, nutritional requirements, quality of life, and enjoyment of eating. Management should extend beyond compensatory strategies alone to include the social and relational dimensions of meals. Active involvement and education of patients and caregivers are essential to support therapeutic adherence and daily implementation of recommendations. Interprofessional collaboration and multimodal educational strategies are crucial to ensuring a coordinated, safe, and effective nutritional approach to OD care.
- Open Access
- 26 September 2026
- Published by Elsevier in Clinical Nutrition ESPEN
- Vol. 76
Feasibility and clinical impact of a tailored nutritional protocol in pediatric elite athletes with cerebral palsy: A pilot study
- 26 September 2026
- Published by Elsevier in Clinical Nutrition ESPEN
- Vol. 76
Open AccessFeasibility and clinical impact of a tailored nutritional protocol in pediatric elite athletes with cerebral palsy: A pilot study
- Open Access
- 9 September 2026
- Published by Springer Nature in BMC Nutrition
Long-term variation of dietary fiber intake in subjects with neurological diseases on a classic ketogenic dietary therapy
- 9 September 2026
- Published by Springer Nature in BMC Nutrition
Open AccessLong-term variation of dietary fiber intake in subjects with neurological diseases on a classic ketogenic dietary therapy
- Open Access
- 9 September 2026
- Published by Springer Nature in Orphanet Journal of Rare Diseases
The effect of pharmacological therapy on the nutritional status and body composition of children with spinal muscular Atrophy: a systematic review
Background: Spinal Muscular Atrophy (SMA) is a rare genetic neuromuscular disorder whose prognosis has significantly improved thanks to disease-modifying therapies (DMTs) such as nusinersen, risdiplam, and onasemnogene abeparvovec. However, their effects on nutritional status and body composition remain incompletely understood. Objective: This systematic review aimed to critically evaluate current evidence regarding the effects of pharmacological therapies on nutrition and body composition in children and adolescents with SMA Types I, II and III. Methods: This systematic review was conducted according to PRISMA 2020 guidelines. PubMed, Scopus, and Web of Science were searched from January 2021 to May 2026. Eligible studies included pediatric patients with SMA Types I–III treated with nusinersen, risdiplam, or onasemnogene abeparvovec and reporting nutritional or body composition outcomes. Methodological quality was evaluated using Joanna Briggs Institute (JBI) tools, and certainty of evidence was assessed using the GRADE framework. Results: Nine studies involving 354 pediatric patients met the inclusion criteria. Nusinersen was associated with improvements in growth indicators and body composition parameters, particularly among ambulatory children. Onasemnogene abeparvovec appeared effective in preserving feeding autonomy when administered early, although established bulbar dysfunction often persisted despite treatment. Limited evidence suggested that risdiplam may provide additional benefit in swallowing function in selected patients previously treated with gene therapy. Overall certainty of evidence ranged from very low to moderate, mainly due to observational study design, heterogeneity of outcome measures, and small sample sizes. Conclusions: Current evidence suggests that DMTs may positively influence selected nutritional and body composition outcomes in pediatric SMA. Nevertheless, persistent dysphagia and feeding difficulties remain common, particularly in severe phenotypes. Standardized nutritional assessment protocols and multidisciplinary management remain essential components of SMA care.
- 9 September 2026
- Published by Springer Nature in Orphanet Journal of Rare Diseases
Open AccessThe effect of pharmacological therapy on the nutritional status and body composition of children with spinal muscular Atrophy: a systematic review
Background: Spinal Muscular Atrophy (SMA) is a rare genetic neuromuscular disorder whose prognosis has significantly improved thanks to disease-modifying therapies (DMTs) such as nusinersen, risdiplam, and onasemnogene abeparvovec. However, their effects on nutritional status and body composition remain incompletely understood. Objective: This systematic review aimed to critically evaluate current evidence regarding the effects of pharmacological therapies on nutrition and body composition in children and adolescents with SMA Types I, II and III. Methods: This systematic review was conducted according to PRISMA 2020 guidelines. PubMed, Scopus, and Web of Science were searched from January 2021 to May 2026. Eligible studies included pediatric patients with SMA Types I–III treated with nusinersen, risdiplam, or onasemnogene abeparvovec and reporting nutritional or body composition outcomes. Methodological quality was evaluated using Joanna Briggs Institute (JBI) tools, and certainty of evidence was assessed using the GRADE framework. Results: Nine studies involving 354 pediatric patients met the inclusion criteria. Nusinersen was associated with improvements in growth indicators and body composition parameters, particularly among ambulatory children. Onasemnogene abeparvovec appeared effective in preserving feeding autonomy when administered early, although established bulbar dysfunction often persisted despite treatment. Limited evidence suggested that risdiplam may provide additional benefit in swallowing function in selected patients previously treated with gene therapy. Overall certainty of evidence ranged from very low to moderate, mainly due to observational study design, heterogeneity of outcome measures, and small sample sizes. Conclusions: Current evidence suggests that DMTs may positively influence selected nutritional and body composition outcomes in pediatric SMA. Nevertheless, persistent dysphagia and feeding difficulties remain common, particularly in severe phenotypes. Standardized nutritional assessment protocols and multidisciplinary management remain essential components of SMA care.
- 20 August 2026
- Published by Taylor & Francis in Nutritional Neuroscience
- p. 1-22
Impact of medium-chain triglyceride with and without ketogenic diet in the management of drug-resistant epilepsy: a systematic review
The ketogenic diet (KD) is an isocaloric, hyperlipidic, normoproteic and hypoglycaemic dietary therapy. It simulates fasting by switching metabolism from glucose to the use of ketone bodies as an e...
- 20 August 2026
- Published by Taylor & Francis in Nutritional Neuroscience
- p. 1-22
Impact of medium-chain triglyceride with and without ketogenic diet in the management of drug-resistant epilepsy: a systematic review
The ketogenic diet (KD) is an isocaloric, hyperlipidic, normoproteic and hypoglycaemic dietary therapy. It simulates fasting by switching metabolism from glucose to the use of ketone bodies as an e...
- Open Access
- 24 June 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1785503
Being eco-sustainable eaters: the role of chronotype and HEXACO personality traits
Background: Chronotype and temperament are stable individual traits that influence behaviors such as eating habits. This research examined their impact on an eco-sustainable diet, characterized by a high intake of plant-based foods and reduced consumption of animal products. Methods: A total of 738 Italian individuals were surveyed regarding their eating habits using a specific food frequency questionnaire. Individual chronotype was assessed via the revised Morningness-Eveningness Questionnaire (rMEQ), while personality traits were measured according to the HEXACO Adjective Scales. The contribution of these factors to the adoption of an eco-sustainable diet was analyzed using hierarchical binary logistic regression. Results: In our sample, a substantial majority ( N = 592; 80.22%) reported a non-eco-sustainable diet, with only 146 participants (19.78%) reporting an eco-sustainable diet. Key predictors of an increased likelihood of adhering to an eco-sustainable diet included being female (OR = 3.05, 95% CI [1.85, 5.03]), a greater preference for morningness (OR = 1.08, 95% CI [1.01, 1.14]), higher levels of Agreeableness (OR = 1.43, 95% CI [1.09, 1.86]), and increased Openness to Experience (OR = 1.60, 95% CI [1.23, 2.07]). Conversely, higher scores in Honesty-Humility (OR = 0.69, 95% CI [0.49, 0.97]), Extraversion (OR = 0.80, 95% CI [0.67, 0.96]), and increasing age (OR = 0.98, 95% CI [0.97, 1.00]) were associated with reduced odds. Conclusion: Both chronobiology and personality traits may significantly influence an individual’s inclination toward eco-sustainable dietary choices. The intrinsic characteristics of Agreeableness and Openness to Experience, but not those associated with Honesty-Humility and Extraversion, may facilitate individuals in addressing the contextual challenges of adopting an eco-sustainable diet.
- 24 June 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1785503
Open AccessBeing eco-sustainable eaters: the role of chronotype and HEXACO personality traits
Background: Chronotype and temperament are stable individual traits that influence behaviors such as eating habits. This research examined their impact on an eco-sustainable diet, characterized by a high intake of plant-based foods and reduced consumption of animal products. Methods: A total of 738 Italian individuals were surveyed regarding their eating habits using a specific food frequency questionnaire. Individual chronotype was assessed via the revised Morningness-Eveningness Questionnaire (rMEQ), while personality traits were measured according to the HEXACO Adjective Scales. The contribution of these factors to the adoption of an eco-sustainable diet was analyzed using hierarchical binary logistic regression. Results: In our sample, a substantial majority ( N = 592; 80.22%) reported a non-eco-sustainable diet, with only 146 participants (19.78%) reporting an eco-sustainable diet. Key predictors of an increased likelihood of adhering to an eco-sustainable diet included being female (OR = 3.05, 95% CI [1.85, 5.03]), a greater preference for morningness (OR = 1.08, 95% CI [1.01, 1.14]), higher levels of Agreeableness (OR = 1.43, 95% CI [1.09, 1.86]), and increased Openness to Experience (OR = 1.60, 95% CI [1.23, 2.07]). Conversely, higher scores in Honesty-Humility (OR = 0.69, 95% CI [0.49, 0.97]), Extraversion (OR = 0.80, 95% CI [0.67, 0.96]), and increasing age (OR = 0.98, 95% CI [0.97, 1.00]) were associated with reduced odds. Conclusion: Both chronobiology and personality traits may significantly influence an individual’s inclination toward eco-sustainable dietary choices. The intrinsic characteristics of Agreeableness and Openness to Experience, but not those associated with Honesty-Humility and Extraversion, may facilitate individuals in addressing the contextual challenges of adopting an eco-sustainable diet.
- Open Access
- 14 January 2026
- Published by Springer Nature in Obesity Surgery
- Vol. 36 (4) , 1450-1457
Bariatric Surgery Outcomes in an Italian Single-Center Study: Does Chronotype Matter?
Background Chronotype reflects an individual’s intrinsic circadian preference for the timing of daily behaviors, including sleep, eating, and physical activity. It influences not only biological rhythms but also lifestyle patterns that may impact metabolic health. In the context of bariatric surgery, numerous factors may affect postoperative outcomes such as weight loss and the risk of weight regain. Given the growing interest in chronobiology and its relevance to obesity management, this study aimed to explore whether chronotype is significantly associated with key weight loss outcomes following bariatric surgery at 6 and 12 months post-intervention. Methods A total of 263 patients underwent bariatric surgery at a single center. Baseline assessments included anthropometric, biochemical, and behavioral evaluations, including chronotype categorization. Postoperative outcomes at 6 and 12 months included absolute weight, BMI, percentage of initial body weight loss (%IBWL), and percentage of excess body weight loss (%EBWL). Results There was no significant difference among the three different chronotypes (evening, intermediate, and morning chronotype) in terms of absolute weight, BMI, %EWL and %IBWL at 6 and 12 months after surgery. Conclusions Our results suggest that chronotype does not seem to play a critical role in weight loss outcomes in bariatric surgery patients, characterized by severe obesity. Further studies are needed to more thoroughly assess the impact of chronotype on bariatric surgery outcomes and a more detailed characterization of chronotype itself in these patients could be decisive.
- 14 January 2026
- Published by Springer Nature in Obesity Surgery
- Vol. 36 (4) , 1450-1457
Open AccessBariatric Surgery Outcomes in an Italian Single-Center Study: Does Chronotype Matter?
Background Chronotype reflects an individual’s intrinsic circadian preference for the timing of daily behaviors, including sleep, eating, and physical activity. It influences not only biological rhythms but also lifestyle patterns that may impact metabolic health. In the context of bariatric surgery, numerous factors may affect postoperative outcomes such as weight loss and the risk of weight regain. Given the growing interest in chronobiology and its relevance to obesity management, this study aimed to explore whether chronotype is significantly associated with key weight loss outcomes following bariatric surgery at 6 and 12 months post-intervention. Methods A total of 263 patients underwent bariatric surgery at a single center. Baseline assessments included anthropometric, biochemical, and behavioral evaluations, including chronotype categorization. Postoperative outcomes at 6 and 12 months included absolute weight, BMI, percentage of initial body weight loss (%IBWL), and percentage of excess body weight loss (%EBWL). Results There was no significant difference among the three different chronotypes (evening, intermediate, and morning chronotype) in terms of absolute weight, BMI, %EWL and %IBWL at 6 and 12 months after surgery. Conclusions Our results suggest that chronotype does not seem to play a critical role in weight loss outcomes in bariatric surgery patients, characterized by severe obesity. Further studies are needed to more thoroughly assess the impact of chronotype on bariatric surgery outcomes and a more detailed characterization of chronotype itself in these patients could be decisive.
- Open Access
Controversies and Perspectives of Time-Qualified Dietary Interventions
Time-qualified dietary interventions, including time-restricted eating (TRE), intermittent fasting (IF), and periodic fasting-mimicking diets (FMDs), have emerged as strategies to improve metabolic health. While preclinical studies consistently demonstrate robust effects on energy metabolism, cardiometabolic function, and longevity, translation to humans remains heterogeneous. In free-living settings, most metabolic improvements observed with TRE and IF appear primarily driven by spontaneous caloric restriction rather than meal timing per se, and isocaloric randomized controlled trials generally show no additional benefits compared to standard calorie restriction. Evidence supporting circadian-specific advantages, particularly for early TRE, is promising but inconsistent and often context-dependent. Important uncertainties also persist regarding long-term efficacy, lean mass preservation, safety in specific populations, and the physiological impact of extended fasting windows. Despite these controversies, time-qualified diets represent a paradigm shift in nutritional science by integrating chronobiology with dietary patterns. Future directions include tailoring eating windows to individual chronotypes, combining fasting regimens with high-quality dietary patterns and structured physical activity, and clarifying the molecular mechanisms that may mediate calorie-independent benefits. Large, long-term, mechanistically informed human trials are essential to determine whether aligning eating behaviors with circadian biology can produce durable clinical improvements. Such work will ultimately shape the role of personalized chrononutrition in preventive and therapeutic nutrition.
Open AccessControversies and Perspectives of Time-Qualified Dietary Interventions
Time-qualified dietary interventions, including time-restricted eating (TRE), intermittent fasting (IF), and periodic fasting-mimicking diets (FMDs), have emerged as strategies to improve metabolic health. While preclinical studies consistently demonstrate robust effects on energy metabolism, cardiometabolic function, and longevity, translation to humans remains heterogeneous. In free-living settings, most metabolic improvements observed with TRE and IF appear primarily driven by spontaneous caloric restriction rather than meal timing per se, and isocaloric randomized controlled trials generally show no additional benefits compared to standard calorie restriction. Evidence supporting circadian-specific advantages, particularly for early TRE, is promising but inconsistent and often context-dependent. Important uncertainties also persist regarding long-term efficacy, lean mass preservation, safety in specific populations, and the physiological impact of extended fasting windows. Despite these controversies, time-qualified diets represent a paradigm shift in nutritional science by integrating chronobiology with dietary patterns. Future directions include tailoring eating windows to individual chronotypes, combining fasting regimens with high-quality dietary patterns and structured physical activity, and clarifying the molecular mechanisms that may mediate calorie-independent benefits. Large, long-term, mechanistically informed human trials are essential to determine whether aligning eating behaviors with circadian biology can produce durable clinical improvements. Such work will ultimately shape the role of personalized chrononutrition in preventive and therapeutic nutrition.
- Open Access
- 21 October 2025
- Vol. 27, e72054
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.
Obesity is a chronic, relapsing disease influenced by environmental, lifestyle, biological, and genetic factors, affecting over 1 billion people globally. Treatment for adults typically involves multicomponent lifestyle interventions-diet, physical activity, and behavior change-for at least 6-12 months. However, adherence is often low, and in-person sessions can be time-consuming and costly. Digital therapeutics (DTx), which enhance patient engagement and support long-term outcomes, have proven effective in managing chronic and mental health conditions. DTx offer scalable, evidence-based solutions with the potential to improve obesity management. The Digital Therapy to Promote Weight Loss in Patients With Obesity by Increasing Their Adherence to Treatment (DEMETRA) study is a prospective, multicenter, pragmatic, randomized, double-arm, single-blind, placebo-controlled trial evaluating the 6-month efficacy of an innovative, multicomponent digital intervention for obesity, which combines dietary, physical activity, and behavioral strategies in people with obesity (primary objective). Secondary objectives were assessing changes in BMI, waist circumference, blood pressure, glucose metabolism, lipid profile, adherence, and factors associated with absolute 6-month weight loss. The trial was conducted at 2 obesity centers in Italy with 246 participants aged 18-65 years (BMI 30-45 kg/m2), randomly assigned to either the Digital Therapeutics for Obesity (DTxO) app or a placebo app. DTxO offered personalized diet plans, exercise routines, and psycho-behavioral support, while the placebo app only allowed users to log data without feedback. Both groups followed a Mediterranean-style low-calorie diet with an 800 kcal/day deficit. On average, participants used the DTxO app for 42 minutes/day and the placebo app for 35 minutes, primarily for physical activity tracking. Univariable and multivariable generalized linear models were used to assess associations with 6-month absolute weight change (primary end point) and percent weight change (secondary end point). Overall, 207 participants (84.1%) completed the 6-month visit. Both arms achieved a statistically significant absolute (DtxO: -3.2 kg, IQR -6.0 kg to -0.9 kg; placebo: -4.0 kg, IQR -6.9 kg to -0.5 kg; P<.001) and percent loss in body weight (DtxO: -3.0%, IQR -5.7% to -0.8%; placebo: -4.0%, IQR -8.5% to -0.5%; P<.001) after 6 months, without significant between-group differences (univariable generalized linear models: P=.34 and P=.17, respectively). Univariable regression analyses showed a significant association between adherence to app use and 6-month absolute weight loss (β=-.06, SE 0.02, P=.01) as well as percent weight loss (β=-.05, SE 0.01, P=.01). Adherent participants, defined as those with overall adherence at or above the 75th percentile of daily usage, included 35 individuals in the intervention group and 10 in the placebo group. In this subgroup, the estimated 6-month mean absolute weight change was -7.02 kg (95% CI -9.45 to -4.59) in the DTxO-adherent group and -3.50 kg (95% CI -7.01 to 0.01) in the placebo-adherent group (P=.02). The estimated 6-month mean percent change in weight was -6.31% (95% CI -8.86 to -3.76) in the DTxO-adherent group and -2.78% (95% CI -6.48 to 0.92) in the placebo-adherent group (P=.03). A significantly greater weight loss (P=.01 for study arm, either on absolute or percent change in weight from baseline) among adherent participants randomized to the DTxO app was also confirmed by analyses using mixed linear models for repeated measures. Although overall weight loss did not differ significantly between the DTxO and placebo groups, participants who used the DTxO app for at least 40% of the expected time achieved significantly greater weight loss. These results suggest that higher engagement with DTx can improve obesity outcomes. Further research should explore combining DTxO with pharmacological treatments or bariatric surgery. ClinicalTrials.gov NCT05394779; https://clinicaltrials.gov/ct2/show/NCT05394779. RR2-10.3389/fdgth.2023.1159744.
- 21 October 2025
- Vol. 27, e72054
Open AccessEffectiveness 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.
Obesity is a chronic, relapsing disease influenced by environmental, lifestyle, biological, and genetic factors, affecting over 1 billion people globally. Treatment for adults typically involves multicomponent lifestyle interventions-diet, physical activity, and behavior change-for at least 6-12 months. However, adherence is often low, and in-person sessions can be time-consuming and costly. Digital therapeutics (DTx), which enhance patient engagement and support long-term outcomes, have proven effective in managing chronic and mental health conditions. DTx offer scalable, evidence-based solutions with the potential to improve obesity management. The Digital Therapy to Promote Weight Loss in Patients With Obesity by Increasing Their Adherence to Treatment (DEMETRA) study is a prospective, multicenter, pragmatic, randomized, double-arm, single-blind, placebo-controlled trial evaluating the 6-month efficacy of an innovative, multicomponent digital intervention for obesity, which combines dietary, physical activity, and behavioral strategies in people with obesity (primary objective). Secondary objectives were assessing changes in BMI, waist circumference, blood pressure, glucose metabolism, lipid profile, adherence, and factors associated with absolute 6-month weight loss. The trial was conducted at 2 obesity centers in Italy with 246 participants aged 18-65 years (BMI 30-45 kg/m2), randomly assigned to either the Digital Therapeutics for Obesity (DTxO) app or a placebo app. DTxO offered personalized diet plans, exercise routines, and psycho-behavioral support, while the placebo app only allowed users to log data without feedback. Both groups followed a Mediterranean-style low-calorie diet with an 800 kcal/day deficit. On average, participants used the DTxO app for 42 minutes/day and the placebo app for 35 minutes, primarily for physical activity tracking. Univariable and multivariable generalized linear models were used to assess associations with 6-month absolute weight change (primary end point) and percent weight change (secondary end point). Overall, 207 participants (84.1%) completed the 6-month visit. Both arms achieved a statistically significant absolute (DtxO: -3.2 kg, IQR -6.0 kg to -0.9 kg; placebo: -4.0 kg, IQR -6.9 kg to -0.5 kg; P<.001) and percent loss in body weight (DtxO: -3.0%, IQR -5.7% to -0.8%; placebo: -4.0%, IQR -8.5% to -0.5%; P<.001) after 6 months, without significant between-group differences (univariable generalized linear models: P=.34 and P=.17, respectively). Univariable regression analyses showed a significant association between adherence to app use and 6-month absolute weight loss (β=-.06, SE 0.02, P=.01) as well as percent weight loss (β=-.05, SE 0.01, P=.01). Adherent participants, defined as those with overall adherence at or above the 75th percentile of daily usage, included 35 individuals in the intervention group and 10 in the placebo group. In this subgroup, the estimated 6-month mean absolute weight change was -7.02 kg (95% CI -9.45 to -4.59) in the DTxO-adherent group and -3.50 kg (95% CI -7.01 to 0.01) in the placebo-adherent group (P=.02). The estimated 6-month mean percent change in weight was -6.31% (95% CI -8.86 to -3.76) in the DTxO-adherent group and -2.78% (95% CI -6.48 to 0.92) in the placebo-adherent group (P=.03). A significantly greater weight loss (P=.01 for study arm, either on absolute or percent change in weight from baseline) among adherent participants randomized to the DTxO app was also confirmed by analyses using mixed linear models for repeated measures. Although overall weight loss did not differ significantly between the DTxO and placebo groups, participants who used the DTxO app for at least 40% of the expected time achieved significantly greater weight loss. These results suggest that higher engagement with DTx can improve obesity outcomes. Further research should explore combining DTxO with pharmacological treatments or bariatric surgery. ClinicalTrials.gov NCT05394779; https://clinicaltrials.gov/ct2/show/NCT05394779. RR2-10.3389/fdgth.2023.1159744.
- Open Access
- 10 June 2025
- Published by Springer Nature in Nutrition & Metabolism
- Vol. 22 (1) , 1-10
How sustainable are hypocaloric and balanced diets for weight loss?
Promoting healthy diets with low environmental impact is pivotal. The EAT-IT diet aligns with the EAT-Lancet Commission, tailored to Italian food habits. However, a comparison with weight loss diets has not been done. This cross-sectional study compares EAT-IT with historical diets of an urban nutritional care facility. To compare conventional hypocaloric and balanced weight-loss diets with the sustainable EAT-IT diet, investigating their alignment, the influence of BMI and sex on EAT-IT adherence, to optimize the EAT-IT diet for weight management. 4032 patients (72% female, median age 49y, BMI 29 kg/m2) received hypocaloric diets based on Mediterranean principles (51% carbohydrates, 31% lipids, 0.9 g/kg body weight protein, 17 g/1000 kcal fiber), following Italian dietary guidelines. Linear regression revealed lower EAT-IT alignment in males (-2.6%, p < 0.001) and a small BMI effect on food group adherence (0.4%, p = 0.005). Only 44% of prescribed food groups were in line to EAT-IT. Protein sources (fish 13%, red meat 13%) were generally higher than EAT-IT, except for legumes (26%) and nuts (10%) prescribed in lower quantities and frequencies, as well as vegetable oil (12%) and fresh fruits (11%). Complex carbohydrates-rich foods (13% bread, 12% pasta/cereals) and vegetables (21%) were prescribed in higher quantities in hypocaloric diets, being more aligned with the EAT-IT pattern. Protein sources, being less sustainable, pose challenges in hypocaloric diets. Differences in consumption of vegetable foods were found according to sex and BMI, highlighting the struggle to meet EAT-IT sustainability criteria. Reconciliation between sustainable and hypocaloric dietary interventions is crucial.
- 10 June 2025
- Published by Springer Nature in Nutrition & Metabolism
- Vol. 22 (1) , 1-10
Open AccessHow sustainable are hypocaloric and balanced diets for weight loss?
Promoting healthy diets with low environmental impact is pivotal. The EAT-IT diet aligns with the EAT-Lancet Commission, tailored to Italian food habits. However, a comparison with weight loss diets has not been done. This cross-sectional study compares EAT-IT with historical diets of an urban nutritional care facility. To compare conventional hypocaloric and balanced weight-loss diets with the sustainable EAT-IT diet, investigating their alignment, the influence of BMI and sex on EAT-IT adherence, to optimize the EAT-IT diet for weight management. 4032 patients (72% female, median age 49y, BMI 29 kg/m2) received hypocaloric diets based on Mediterranean principles (51% carbohydrates, 31% lipids, 0.9 g/kg body weight protein, 17 g/1000 kcal fiber), following Italian dietary guidelines. Linear regression revealed lower EAT-IT alignment in males (-2.6%, p < 0.001) and a small BMI effect on food group adherence (0.4%, p = 0.005). Only 44% of prescribed food groups were in line to EAT-IT. Protein sources (fish 13%, red meat 13%) were generally higher than EAT-IT, except for legumes (26%) and nuts (10%) prescribed in lower quantities and frequencies, as well as vegetable oil (12%) and fresh fruits (11%). Complex carbohydrates-rich foods (13% bread, 12% pasta/cereals) and vegetables (21%) were prescribed in higher quantities in hypocaloric diets, being more aligned with the EAT-IT pattern. Protein sources, being less sustainable, pose challenges in hypocaloric diets. Differences in consumption of vegetable foods were found according to sex and BMI, highlighting the struggle to meet EAT-IT sustainability criteria. Reconciliation between sustainable and hypocaloric dietary interventions is crucial.