scholarly journals The Mediterranean Eating in Scotland Experience project: evaluation of an Internet-based intervention promoting the Mediterranean diet

2005 ◽  
Vol 94 (2) ◽  
pp. 290-298 ◽  
Author(s):  
Angeliki Papadaki ◽  
Jane A. Scott
Keyword(s):  
Nutrition Education ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Saturated Fat ◽  
Hdl Cholesterol ◽  
Control Group ◽  
Monounsaturated Fat ◽  
Feedback Intervention ◽  
Intention To Treat ◽  
The Mediterranean

A 6-month intervention study with a quasi-experimental design was conducted to evaluate the effectiveness of an Internet-based, stepwise, tailored-feedback intervention promoting four key components of the Mediterranean diet. Fifty-three (intervention group) and nineteen (control group) healthy females were recruited from the Universities of Glasgow and Glasgow Caledonian, Scotland, respectively. Participants in the intervention group received tailored dietary and psychosocial feedback and Internet nutrition education over a 6-month period, while participants in the control group were provided with minimal dietary feedback and general healthy-eating brochures. Internet education was provided via an innovative Mediterranean Eating Website. Dietary changes were assessed with 7 d estimated food diaries at baseline and 6 months, and data were analysed to calculate the Mediterranean Diet Score, a composite score based on the consumption of eight components of the traditional Mediterranean diet. The ‘intention-to-treat’ analyses showed that, at 6 months, participants in the intervention group had significantly increased their intake of vegetables, fruits and legumes, as well as the MUFA:saturated fatty acid ratio in their diet, and had significantly increased plasma HDL-cholesterol levels and a reduced ratio of total:HDL-cholesterol. Participants in the control group increased their intake of legumes but showed no other favourable significant changes compared with baseline. This Internet-based, tailored-feedback intervention promoting components of the Mediterranean diet holds promise in encouraging a greater consumption of plant foods, as well as increasing monounsaturated fat and decreasing saturated fat in the Scottish diet; it also shows that the Mediterranean diet can be adopted by healthy individuals in northern European countries.

scholarly journals Impact of Mediterranean diet education versus posted leaflet on dietary habits and serum cholesterol in a high risk population for cardiovascular disease

2000 ◽  
Vol 3 (3) ◽  
pp. 273-283 ◽  
Author(s):  
Wanda JE Bemelmans ◽  
Jan Broer ◽  
Jeanne HM de Vries ◽  
Karin Fam Hulshof ◽  
Jo F May ◽  
...  
Keyword(s):  
Mediterranean Diet ◽  
Dietary Habits ◽  
Intervention Group ◽  
Saturated Fat ◽  
Control Group ◽  
Fat Intake ◽  
Group Education ◽  
The Mediterranean ◽  
Intensive Group ◽  
Saturated Fat Intake

AbstractObjectiveTo investigate the impact of intensive group education on the Mediterranean diet on dietary intake and serum total cholesterol after 16 and 52 weeks, compared to a posted leaflet with the Dutch nutritional guidelines, in the context of primary prevention of cardiovascular disease (CVD).DesignControlled comparison study of an intervention group given intensive group education about the Mediterranean diet and a control group of hypercholesterolaemic persons given usual care by general practitioners (GPs).SettingA socioeconomically deprived area in the Netherlands with an elevated coronary heart disease (CHD) mortality ratio.SubjectsTwo hundred and sixty-six hypercholesterolaemic persons with at least two other CVD risk factors.ResultsAfter 52 weeks, the intervention group decreased total and saturated fat intake more than the control group (net differences were 1.8 en% (95%CI 0.2–3.4) and 1.1 en% (95%CI 0.4–1.9), respectively). According to the Mediterranean diet guidelines the intake of fish, fruit, poultry and bread increased in the intervention group, more than in the control group. Within the intervention group, intake of fish (+100%), poultry (+28%) and bread (+6%) was significantly increased after 1 year (P< 0.05). The intensive programme on dietary education did not significantly lower serum cholesterol level more (−3%) than the posted leaflet (−2%) (net difference 0.06 mmol l−1, 95%CI −0.10 to 0.22). Initially, the body mass index (BMI) decreased more in the intervention group, but after 1 year the intervention and control group gained weight equally (+1%).ConclusionsDespite beneficial changes in dietary habits in the intervention group compared with the control group, after 1 year BMI increased and total fat and saturated fat intake were still too high.

scholarly journals A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial

10.2196/21436 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e21436
Author(s):  
Leticia Goni ◽  
Víctor de la O ◽  
M Teresa Barrio-López ◽  
Pablo Ramos ◽  
Luis Tercedor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Mediterranean Diet ◽  
Retention Rate ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mediterranean

Background The Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored. Objective This study aims to assess the effectiveness of a remotely provided Mediterranean diet–based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF). Methods The PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: Recommended foods, Menus, News and Online resources, Practical tips, Mediterranean diet classroom, and Your personal experience. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone. Results A total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; P<.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (P<.001), olive oil (P<.001), whole grain cereals (P=.002), pulses (P<.001), nuts (P<.001), white fish (P<.001), fatty fish (P<.001), and white meat (P=.007), and a significant reduction in refined cereals (P<.001), red and processed meat (P<.001), and sweets (P<.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (P<.001) and fiber (P<.001), and they decreased their intake of carbohydrates (P=.02) and saturated fatty acids (P<.001) compared with the control group. Conclusions The remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation. Trial Registration ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843

scholarly journals Effectiveness of A Multifactorial Intervention in Increasing Adherence to the Mediterranean Diet among Patients with Diabetes Mellitus Type 2: A Controlled and Randomized Study (EMID Study)

Nutrients ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 162 ◽  
Author(s):  
Rosario Alonso-Domínguez ◽  
Luis García-Ortiz ◽  
Maria Patino-Alonso ◽  
Natalia Sánchez-Aguadero ◽  
Manuel Gómez-Marcos ◽  
...  
Keyword(s):  
Mediterranean Diet ◽  
Diet Quality ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Multifactorial Intervention ◽  
The Mediterranean

The Mediterranean diet (MD) is recognized as one of the healthiest dietary patterns and has benefits such as improving glycaemic control among patients with type 2 diabetes (T2DM). Our aim is to assess the effectiveness of a multifactorial intervention to improve adherence to the MD, diet quality and biomedical parameters. The EMID study is a randomized and controlled clinical trial with two parallel groups and a 12-month follow-up period. The study included 204 subjects between 25–70 years with T2DM. The participants were randomized into intervention group (IG) and control group (CG). Both groups received brief advice about healthy eating and physical activity. The IG participants additionally took part in a food workshop, five walks and received a smartphone application for three months. The population studied had a mean age of 60.6 years. At the 3-month follow-up visit, there were improvements in adherence to the MD and diet quality of 2.2 and 2.5 points, compared to the baseline visit, respectively, in favour of the IG. This tendency of the improvement was maintained, in favour of the IG, at the 12-month follow-up visit. In conclusion, the multifactorial intervention performed could improve adherence to the MD and diet quality among patients with T2DM.

scholarly journals The Mediterranean diet: science and practice

2006 ◽  
Vol 9 (1a) ◽  
pp. 105-110 ◽  
Author(s):  
Walter C Willett
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Mediterranean Diet ◽  
Fruits And Vegetables ◽  
Hdl Cholesterol ◽  
Metabolic Effects ◽  
Health Study ◽  
Monounsaturated Fat ◽  
Daily Consumption ◽  
The Mediterranean

AbstractObjectiveTo provide an overview of research relevant to the Mediterranean diet.DesignPersonal perspectives.SettingInternational.SubjectPopulations in Europe, North America, Asia.ResultsApproximately 50 years ago, Keys and colleagues described strikingly low rates of coronary heart disease in the Mediterranean region, where fat intake was relatively high but largely from olive oil. Subsequent controlled feeding studies have shown that compared to carbohydrate, both monounsaturated and polyunsaturated fats reduce LDL and triglycerides and increase HDL cholesterol. Importantly, these beneficial metabolic effects are greater in the presence of underlying insulin resistance. In a detailed analysis within the Nurses' Health Study, trans fat from partially hydrogenated vegetable oils (absent in traditional Mediterranean diets) was most strongly related to risk of heart disease, and both polyunsaturated and monounsaturated fat were inversely associated with risk. Epidemiologic evidence has also supported beneficial effects of higher intakes of fruits and vegetables, whole grains, fish, and daily consumption of moderate amounts of alcohol. Together with regular physical activity and not smoking, our analyses suggest that over 80% of coronary heart disease, 70% of stroke, and 90% of type 2 diabetes can be avoided by healthy food choices that are consistent with the traditional Mediterranean diet.ConclusionBoth epidemiologic and metabolic studies suggest that individuals can benefit greatly by adopting elements of Mediterranean diets.

scholarly journals Adherence to Mediterranean Diet and Metabolic Syndrome in BRCA Mutation Carriers

2017 ◽  
Vol 17 (1) ◽  
pp. 153-160 ◽  
Author(s):  
Eleonora Bruno ◽  
Siranoush Manoukian ◽  
Elisabetta Venturelli ◽  
Andreina Oliverio ◽  
Francesca Rovera ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Metabolic Syndrome ◽  
Mediterranean Diet ◽  
Dietary Intervention ◽  
Brca Mutation ◽  
Intervention Group ◽  
Control Group ◽  
Mutation Carriers ◽  
Brca Mutation Carriers ◽  
The Mediterranean

Background. Insulin resistance is associated with higher breast cancer (BC) penetrance in BRCA mutation carriers. Metabolic syndrome (MetS), an insulin resistance syndrome, can be reversed by adhering to the Mediterranean diet (MedDiet). In a dietary intervention trial on BRCA mutation carriers, we evaluated adherence to the MedDiet, and the association with the MetS, by analyzing data from the Mediterranean Diet Adherence Screener (MEDAS). Methods. BRCA mutation carriers, with or without BC, aged 18 to 70 years, were eligible for the trial. After the baseline examinations, women were randomized to a dietary intervention or to a control group. Both groups completed the MEDAS at baseline and at the end of the dietary intervention. Results. A total of 163 women completed the 6 months of dietary intervention. Compared with controls, the women in the intervention group significantly reduced their consumption of red meat ( P < .01) and commercial sweets ( P < .01) and their MEDAS score rose significantly (+1.3 vs +0.55, P = .02). The number of MetS parameters decreased with increasing points of adherence to the MEDAS score ( P = .01). In the intervention group, there was a significant association with the greater reduction of MetS. Conclusion. BRCA mutation carriers in the intervention group experienced greater improvement in their MedDiet and MetS parameters.

scholarly journals Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3597
Author(s):  
Patricia Salamanca-González ◽  
Rosa Maria Valls-Zamora ◽  
Anna Pedret-Figuerola ◽  
Mar Sorlí-Aguilar ◽  
Antoni Santigosa-Ayala ◽  
...  
Keyword(s):  
Social Networks ◽  
Lung Function ◽  
Respiratory Disease ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Improve Lung Function ◽  
Randomized Controlled ◽  
The Mediterranean

Background: Diet can help preserve lung function in smokers, as well as aid individuals who avoid smoking. This study aimed to evaluate the effectiveness of a nutritional intervention, using the Social Networks 2.0 tool, to increase adherence to the Mediterranean diet (MD) and improve lung function in smokers without prior respiratory disease. Methods: A randomized controlled parallel design was used. The participants were assigned to either the intervention or control group. Data from representative smokers without respiratory disease (n = 77) aged 18–70 years were analyzed. The participants completed a validated semi-quantitative food-frequency questionnaire, and their adherence to the diet was evaluated by using the questionnaire called the Mediterranean Diet Adherence Score (MEDAS, with 14 items), which considers ≥9 points to indicate high adherence. The lung function was assessed by spirometry. Associations among variables were determined by logistic regression. Results: A comparison of the variables at the end of the study between the control and intervention groups showed that the intervention significantly increased adherence to the MD based on the MEDAS questionnaire (0.69 (2.1) vs. 2.05 (2.03); p = 0.009). Specifically, the consumption of fruits was increased after two years in both groups; however, a more significant increase was detected in the intervention group (121 (178) vs. 12.7 (167) in the control group; p-value = 0.008). In the unadjusted analysis, the intervention only showed a statistical significant increase in the score of adherence to the MD (β: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (β: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (β: 1.17; 95% CI 0.02; 2.31; p = 0.046). The pulmonary function parameters improved more in the intervention group; however, no significant differences were observed between the two groups. Conclusions: A nutritional intervention based on a dietetic-nutritional education program resulted in a significant increase in adherence to the MD. However, some evidence suggests that an MD dietary intervention can improve lung function, but in our study, we were not able to demonstrate this. Further research is needed to obtain more robust data and confirm a possible benefit of the program before it can be extended to general practice.

scholarly journals Educational intervention to improve adherence to the Mediterranean diet among parents and their children aged 1–2 years. EniM clinical trial

2015 ◽  
Vol 19 (6) ◽  
pp. 1131-1144 ◽  
Author(s):  
Margarita Roset-Salla ◽  
Joana Ramon-Cabot ◽  
Jordi Salabarnada-Torras ◽  
Guillem Pera ◽  
Albert Dalmau
Keyword(s):  
Mediterranean Diet ◽  
Educational Intervention ◽  
Day Care ◽  
Intervention Group ◽  
Community Setting ◽  
Educational Programme ◽  
Controlled Study ◽  
Control Group ◽  
Day Care Centres ◽  
The Mediterranean

AbstractObjectiveThe objective of the present study was to evaluate the effectiveness of an educational programme on healthy alimentation, carried out in day-care centres and aimed at the parents of children from 1 to 2 years of age, regarding the acquisition of healthy eating habits among themselves and their children.DesignWe performed a multicentre, multidisciplinary, randomized controlled study in a community setting.SettingThe EniM study (nutritional intervention study among children from Mataró) was performed in twelve day-care centres in Mataró (Spain). Centres were randomized into a control group (CG) and an intervention group (IG). IG received four or five educational workshops on diet, CG did not have workshops.SubjectsChildren, not exclusively breast-fed, from 1 to 2 years of age, in the participating day-care centres and the persons responsible for their alimentation (mother or father).ResultsThirty-five per cent of the IG did not attend the minimum of three workshops and were excluded. The CG included seventy-four children and seventy-two parents and the IG seventy-five children and sixty-seven parents. Both groups were comparable at baseline. Basal adherence to the Mediterranean diet was 56·4 % in parents (Gerber index) and 7·7 points in children (Kidmed test). At 8 months, Mediterranean diet adherence had improved in the IG by 5·8 points in the Gerber index (P=0·01) and 0·6 points in the Kidmed test (P=0·02) compared with the CG.ConclusionsThis educational intervention performed in parents at the key period of incorporation of a 1–2-year-old child to the family table showed significant increases in adherence of the parents to the Mediterranean diet, suggesting future improvement in different indicators of health and an expected influence on the diet of their children.

scholarly journals A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Leticia Goni ◽  
Víctor de la O ◽  
M Teresa Barrio-López ◽  
Pablo Ramos ◽  
Luis Tercedor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Mediterranean Diet ◽  
Retention Rate ◽  
Intervention Group ◽  
Nutritional Intervention ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mediterranean

BACKGROUND The Prevention With Mediterranean Diet (PREDIMED) trial supported the effectiveness of a nutritional intervention conducted by a dietitian to prevent cardiovascular disease. However, the effect of a remote intervention to follow the Mediterranean diet has been less explored. OBJECTIVE This study aims to assess the effectiveness of a remotely provided Mediterranean diet–based nutritional intervention in obtaining favorable dietary changes in the context of a secondary prevention trial of atrial fibrillation (AF). METHODS The PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study is a 2-year multicenter, randomized, controlled, single-blinded trial to assess the effect of the Mediterranean diet enriched with extra virgin olive oil (EVOO) on the prevention of atrial tachyarrhythmia recurrence after catheter ablation. Participants in sinus rhythm after ablation were randomly assigned to an intervention group (Mediterranean diet enriched with EVOO) or a control group (usual clinical care). The remote nutritional intervention included phone contacts (1 per 3 months) and web-based interventions with provision of dietary recommendations, and participants had access to a web page, a mobile app, and printed resources. The information is divided into 6 areas: <i>Recommended foods</i>, <i>Menus</i>, <i>News and Online resources</i>, <i>Practical tips</i>, <i>Mediterranean diet classroom</i>, and <i>Your personal experience</i>. At baseline and at 1-year and 2-year follow-up, the 14-item Mediterranean Diet Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire were collected by a dietitian by phone. RESULTS A total of 720 subjects were randomized (365 to the intervention group, 355 to the control group). Up to September 2020, 560 subjects completed the first year (560/574, retention rate 95.6%) and 304 completed the second year (304/322, retention rate 94.4%) of the intervention. After 24 months of follow-up, increased adherence to the Mediterranean diet was observed in both groups, but the improvement was significantly higher in the intervention group than in the control group (net between-group difference: 1.8 points in the MEDAS questionnaire (95% CI 1.4-2.2; <i>P</i>&lt;.001). Compared with the control group, the Mediterranean diet intervention group showed a significant increase in the consumption of fruits (<i>P</i>&lt;.001), olive oil (<i>P</i>&lt;.001), whole grain cereals (<i>P</i>=.002), pulses (<i>P</i>&lt;.001), nuts (<i>P</i>&lt;.001), white fish (<i>P</i>&lt;.001), fatty fish (<i>P</i>&lt;.001), and white meat (<i>P</i>=.007), and a significant reduction in refined cereals (<i>P</i>&lt;.001), red and processed meat (<i>P</i>&lt;.001), and sweets (<i>P</i>&lt;.001) at 2 years of intervention. In terms of nutrients, the intervention group significantly increased their intake of omega-3 (<i>P</i>&lt;.001) and fiber (<i>P</i>&lt;.001), and they decreased their intake of carbohydrates (<i>P</i>=.02) and saturated fatty acids (<i>P</i>&lt;.001) compared with the control group. CONCLUSIONS The remote nutritional intervention using a website and phone calls seems to be effective in increasing adherence to the Mediterranean diet pattern among AF patients treated with catheter ablation. CLINICALTRIAL ClinicalTrials.gov NCT03053843; https://www.clinicaltrials.gov/ct2/show/NCT03053843

Relationship Among Adherence to The Mediterranean Diet and Anthropometric and Metabolic Parameters in Subjects with Obesity

2020 ◽  
Vol 20 ◽  
Author(s):  
Luisa Lampignano ◽  
Roberta Zupo ◽  
Rossella Donghia ◽  
Vito Guerra ◽  
Fabio Castellana ◽  
...  
Keyword(s):  
Mediterranean Diet ◽  
Hdl Cholesterol ◽  
Fat Distribution ◽  
Serum Levels ◽  
Overweight And Obesity ◽  
Height Ratio ◽  
Anthropometric Parameters ◽  
Cross Sectional ◽  
Waist To Height Ratio ◽  
The Mediterranean

Background: There is moderate-to-high evidence that the Mediterranean diet prevents increases in body weight and waist circumference in non-obese individuals but less is known about its effects in subjects with overweight and obesity. The present study was focused on exploring the cross-sectional association among the adherence to Mediterranean diet and the most commonly used variables of metabolic and cardiovascular risk factors in a cohort of overweight subjects from a typical Mediterranean region, Apulia, in Southern Italy. Methods:: The study was performed in a cohort of 1214 individuals, all with overweight or obesity but no other clinical condition. We investigated the association among adherence to Mediterranean diet, assessed with the PREDIMED score, and anthropometric parameters [namely body mass index (BMI), WC, waist to height ratio (WHtR) and neck circumference (NC)], fasting serum levels of glucose, insulin, uric acid and lipids (triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol), and blood pressure and insulin resistance, measured by HOMA-IR. Results:: The waist to height ratio was negatively associated to a PREDIMED score ≥7 (p<0.04), whereas HDL cholesterol was positively associated to a PREDIMED score ≥7 (p<0.04) Conclusion: This study suggests that body fat distribution and HDL-cholesterol are the parameters most strongly influenced by MedDiet in Apulian subjects.

Randomized Trial for Weight Loss Using a Digital Therapeutic Application

2021 ◽  
pp. 193229682110008
Author(s):  
Tryggvi Thorgeirsson ◽  
Johanna E. Torfadottir ◽  
Erlendur Egilsson ◽  
Saemundur Oddsson ◽  
Thrudur Gunnarsdottir ◽  
...  
Keyword(s):  
Weight Loss ◽  
Mobile Application ◽  
Intervention Group ◽  
Lifestyle Change ◽  
Noncommunicable Diseases ◽  
Control Group ◽  
Intention To Treat ◽  
Protocol Group ◽  
Lifestyle Program ◽  
Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

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