Obesity, AdolescentMED4YouthNCT04719052
Mediterranean Enriched Diet for Tackling Youth Obesity
A study testing Diet and behavioural intervention in people with Obesity, Adolescent and Lifestyle, Healthy, run by Fundació Eurecat at 1 site in Spain.
Trial summary
The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Lifestyle, Healthy, Diet, Healthy
- What is being tested?
- Diet and behavioural intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2021to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- boys and girls aged 13-17 years
- having obesity, defined as an age- and sex-specific BMI in the 95th percentile or greater (1), or great overweight (age- and sex-specific BMI in the ≥90th to <95th percentile),
- having informed consent (sign by both, one parent and the adolescent),
- and to have a mobile phone with internet access.
Who cannot join
- having diabetes and other metabolic, endocrine and chronic disorders;
- intake of antibiotics, drug, probiotics or nutritional supplements in the last month;
- prescribed medicine to control hypertension, inflammation or dyslipidemia,
- following a prescribed diet for any reason, including weight loss, in the last 3 months;
- following a religion-restricted diet;
- and having allergies or food intolerances in: nuts, pomegranate, bread and/or chickpeas.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours.
It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ≥90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021.
The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ≥95 percentile (obesity) and a caloric restriction <20% of the total energy requirements will be applied in adolescents with BMI ≥90 to <95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.
Read the detailed description
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.
The secondary outcomes are: Adherence to the DM, KidMed questionnaire; Level of physical activity, PAQ-A questionnaire; Habit/food intake: 3-day dietary record, Helena study food frequency questionnaire, Knowledge about food and nutrition, a questionnaire from Helena's study; Quality of life, kid screen-27 Index; Sociodemographic data of the parents; Anthropometric data: weight, height, BMI, body composition, waist circumference, waist-hip ratio; Clinical variables: blood pressure, Biochemical variables and omic determinations: in urine, blood and feces.
In total, the adolescents will receive 5 visits:
- 1 pre-selection visit (to check inclusion / exclusion criteria in the study) (V0)
- 1 inclusion visit (V1) in which stool, urine, and blood samples will be collected, anthropometric measurements (such as weight and waist circumference) and blood pressure will be taken, and questionnaires and records will be answered dietary.
- 1 follow-up visit (V2), at 2 months, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.
- 1 final visit (V3), at 4 months, in which stool, urine, and blood samples will be collected, anthropometric and blood pressure measurements will be made, and questionnaires and dietary records will be answered.
- 1 post-intervention follow-up visit (V4), 4 months after the end of the intervention, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.
- Being tested
- Diet and behavioural intervention
- Keywords
- Youth Obesity, Mediterranean diet, Interventional study, Healthy lifestyles, Educational approach
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and behavioural interventionOther
Also called MEDITERRANEAN DIET
Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet
Diet and behavioural interventionOther
Also called LOW-FAT DIET
Control group will receive a specific diet designed following the characteristics of Low fat Diet.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Experimental | 1) The MD will be based on high consumption of unsaturated fat from vegetable sources (virgin olive oil and nuts) and minimally processed plant foods (vegetables, fruits, nuts, whole grains and legumes), low consumption of meat (especially red and processed meats) and sweets, and moderate consumption of fish and dairy products (mainly yoghurt and cheese). Accordingly, this diet will provide a high amount of mono and polyunsaturated fatty acids, fibre and phenolic compounds.
Adolescents in the MD group will replace the intake of conventional breads by sourdough bread consumption (2 servings of 50-60 g daily) and incorporate into their diet chickpeas (2 servings of 150 g/week chickpeas, minimum one of them in hummus format), and they will consume at least another serving of legumes which can be chickpeas or another legume), pomegranate juice (4 servings of 200ml/week) and mixed nuts (4 servings of 30 g/week). Receives: Other: Diet and behavioural intervention |
| Low-fat diet group | Active comparator | 2) The low-fat diet (control diet) will be based on low consumption of fats. A low-fat diet is the most used diet for obesity treatment in adolescents. This group will not receive any additional specific food by researchers. This diet will be based on the diet proposed as low-fat diet in the PREDIMED study Receives: Other: Diet and behavioural intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline BMI z-score at 4 months and 8 months
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.
Measured: "4 months" and "4 months after study cessation"
Secondary outcomes (18)
Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
Change of Adherence to the Mediterranean Diet using KIDMED test by comparing control between the intervention group
Scores:
=<3 points: Very low-quality diet 4 to 7 points: Need to improve the eating pattern to fit the model Mediterranean.
=>8 points: Optimal Mediterranean diet
Measured: "4 months" and "4 months after study cessation"
Change from baseline Level of physical activity at 4 and 8 months
Change of Physical Activity using the Physical Activity Questionnaire test by comparing control between the intervention group A score 1 indicates low physical activity whereas a score of 5 indicates high physical activity
Measured: "4 months" and "4 months after study cessation"
Change from baseline Habit/food intake at 4 and 8 months
Change of Habit/food intake using 3-day dietary record, Helena study food frequency questionnaire by comparing control between intervention group
Measured: "4 months" and "4 months after study cessation"
Change from baseline Knowledge about food and nutrition intake at 4 and 8 months
Change of Knowledge about food and nutrition intake using Helena's study knowledge questionnaire by comparing control between intervention group
Measured: "4 months" and "4 months after study cessation"
Change from baseline Life quality at 4 and 8 months
Change of life quality using kidscreen-27 Index by comparing control between intervention group
Measured: "4 months" and "4 months after study cessation"
Sociodemographic data of the parents one time frame
Sociodemographic data of the parents will be assessed at baseline of study using Healthy Behaviour in School Age Children. Sociodemographic data will be divided by low, medium or high socioeconomic level.
Measured: 1 time frame
Change from baseline BMI data at 4 and 8 months
BMI will be assessed by weight (kg) / height (m2), and using Centers for Disease Control and Prevention (CDC) BMI percentiles and will be compared between control and intervention group.
Measured: "4 months" and "4 months after study cessation"
Change from baseline waist circumference data at 4 and 8 months
Waist circumference (cm) will be evaluated and will be compared between control and intervention group.
Measured: "4 months" and "4 months after study cessation"
Change from baseline Waist-hip ratio data at 4 and 8 months
Waist-hip ratio will be evaluated by waist and hip circumference and will be compared between control and intervention group.
Measured: "4 months" and "4 months after study cessation"
Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)
Gut-derived metabolites of both groups will be evaluated by Faeces and/or plasma using NMR /GC-MS
Measured: 4 months
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Biomarkers of oxidative stres of both groups will be evaluated by urine using ELISA
Measured: 4 months
Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)
Biomarkers of inflammation of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Measured: 4 months
Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)
Biomarkers of adipose tissue function of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Measured: 4 months
Change of Biomarkers of insulin resistance
Biomarkers of insulin resistance of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Measured: 4 months
Change of biomarkers of cardiovascular risk (TMAO)
Biomarkers of cardiovascular risk of both groups will be evaluated by plasma and urine using UHPLC MS
Measured: 4 months
Change of circulating levels of glucose and blood lipid profile
Circulating levels of glucose and blood lipid profile of both groups will be evaluated using Enzymatic assays
Measured: 4 months
Change of Food Intake biomarkers
Food Intake biomarkers of both groups will be evaluated by urine using Metabolomics (UHPLC MS)
Measured: 4 months
Change of Advanced glycation end products (AGEs) related analyses
Advanced glycation end products will be assessed by plasma or erythrocytes using ELISA / enzymatic assays
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 May 2021
- Primary completion9 Oct 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, blind, single-randomized, parallel, clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, University of Coimbra, Hospital Universitari Sant Joan de Reus
- Responsible party
- Principal investigator, Antoni Caimari, Fundació Eurecat
- Investigators
- Antoni Caimari, PhD, Principal investigator, Eurecat-Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719052
- Sponsor's protocol ID
- 1
- Acronym
- MED4Youth
- Status last verified
- Oct 2024
- First submitted
- 14 Jan 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared with other researchers involved in the MED4Youth study
Publications
Guideline: Assessing and Managing Children at Primary Health-Care Facilities to Prevent Overweight and Obesity in the Context of the Double Burden of Malnutrition: Updates for the Integrated Management of Childhood Illness (IMCI). Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK487902/
PubMed 29578661Miller AL, Lee HJ, Lumeng JC. Obesity-associated biomarkers and executive function in children. Pediatr Res. 2015 Jan;77(1-2):143-7. doi: 10.1038/pr.2014.158. Epub 2014 Oct 13.
PubMed 25310758US Preventive Services Task Force; Grossman DC, Bibbins-Domingo K, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Obesity in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Jun 20;317(23):2417-2426. doi: 10.1001/jama.2017.6803.
PubMed 28632874Schroder H, Mendez MA, Ribas-Barba L, Covas MI, Serra-Majem L. Mediterranean diet and waist circumference in a representative national sample of young Spaniards. Int J Pediatr Obes. 2010 Dec;5(6):516-9. doi: 10.3109/17477161003777417. Epub 2010 Sep 23.
PubMed 20863166Velazquez-Lopez L, Santiago-Diaz G, Nava-Hernandez J, Munoz-Torres AV, Medina-Bravo P, Torres-Tamayo M. Mediterranean-style diet reduces metabolic syndrome components in obese children and adolescents with obesity. BMC Pediatr. 2014 Jul 5;14:175. doi: 10.1186/1471-2431-14-175.
PubMed 24997634Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2.
PubMed 30389673Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and weight loss: meta-analysis of randomized controlled trials. Metab Syndr Relat Disord. 2011 Feb;9(1):1-12. doi: 10.1089/met.2010.0031. Epub 2010 Oct 25.
PubMed 20973675Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
PubMed 28254269Abbondio M, Palomba A, Tanca A, Fraumene C, Pagnozzi D, Serra M, Marongiu F, Laconi E, Uzzau S. Fecal Metaproteomic Analysis Reveals Unique Changes of the Gut Microbiome Functions After Consumption of Sourdough Carasau Bread. Front Microbiol. 2019 Jul 30;10:1733. doi: 10.3389/fmicb.2019.01733. eCollection 2019.
PubMed 31417524Stamataki NS, Yanni AE, Karathanos VT. Bread making technology influences postprandial glucose response: a review of the clinical evidence. Br J Nutr. 2017 Apr;117(7):1001-1012. doi: 10.1017/S0007114517000770. Epub 2017 May 2.
PubMed 28462730Wallace TC, Murray R, Zelman KM. The Nutritional Value and Health Benefits of Chickpeas and Hummus. Nutrients. 2016 Nov 29;8(12):766. doi: 10.3390/nu8120766.
PubMed 27916819Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Cabre-Vila JJ, Salas-Salvado J. Effects of one serving of mixed nuts on serum lipids, insulin resistance and inflammatory markers in patients with the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2011 Feb;21(2):126-35. doi: 10.1016/j.numecd.2009.08.005. Epub 2009 Dec 22.
PubMed 20031380Kerimi A, Nyambe-Silavwe H, Gauer JS, Tomas-Barberan FA, Williamson G. Pomegranate juice, but not an extract, confers a lower glycemic response on a high-glycemic index food: randomized, crossover, controlled trials in healthy subjects. Am J Clin Nutr. 2017 Dec;106(6):1384-1393. doi: 10.3945/ajcn.117.161968. Epub 2017 Oct 11.
PubMed 29021286Gheflati A, Mohammadi M, Ramezani-Jolfaie N, Heidari Z, Salehi-Abargouei A, Nadjarzadeh A. Does pomegranate consumption affect weight and body composition? A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2019 May;33(5):1277-1288. doi: 10.1002/ptr.6322. Epub 2019 Mar 18.
PubMed 30882964Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678.
PubMed 24987952
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Enriched Diet for Tackling Youth Obesity
- ClinicalTrials.gov ID
- NCT04719052
- Acronym / sponsor ID
- MED4Youth / 1
- Keywords
- Youth Obesity, Mediterranean diet, Interventional study, Healthy lifestyles, Educational approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- University of Parma, University of Coimbra, Hospital Universitari Sant Joan de Reus
- Study start
- 25 May 2021 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours.
It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ≥90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021.
The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ≥95 percentile (obesity) and a caloric restriction <20% of the total energy requirements will be applied in adolescents with BMI ≥90 to <95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.
Detailed description
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.
The secondary outcomes are: Adherence to the DM, KidMed questionnaire; Level of physical activity, PAQ-A questionnaire; Habit/food intake: 3-day dietary record, Helena study food frequency questionnaire, Knowledge about food and nutrition, a questionnaire from Helena's study; Quality of life, kid screen-27 Index; Sociodemographic data of the parents; Anthropometric data: weight, height, BMI, body composition, waist circumference, waist-hip ratio; Clinical variables: blood pressure, Biochemical variables and omic determinations: in urine, blood and feces.
In total, the adolescents will receive 5 visits:
- 1 pre-selection visit (to check inclusion / exclusion criteria in the study) (V0)
- 1 inclusion visit (V1) in which stool, urine, and blood samples will be collected, anthropometric measurements (such as weight and waist circumference) and blood pressure will be taken, and questionnaires and records will be answered dietary.
- 1 follow-up visit (V2), at 2 months, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.
- 1 final visit (V3), at 4 months, in which stool, urine, and blood samples will be collected, anthropometric and blood pressure measurements will be made, and questionnaires and dietary records will be answered.
- 1 post-intervention follow-up visit (V4), 4 months after the end of the intervention, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A multicentre, blind, single-randomized, parallel, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Experimental | Other: Diet and behavioural intervention1) The MD will be based on high consumption of unsaturated fat from vegetable sources (virgin olive oil and nuts) and minimally processed plant foods (vegetables, fruits, nuts, whole grains and legumes), low consumption of meat (especially red and processed meats) and sweets, and moderate consumption of fish and dairy products (mainly yoghurt and cheese). Accordingly, this diet will provide a high amount of mono and polyunsaturated fatty acids, fibre and phenolic compounds. Adolescents in the MD group will replace the intake of conventional breads by sourdough bread consumption (2 servings of 50-60 g daily) and incorporate into their diet chickpeas (2 servings of 150 g/week chickpeas, minimum one of them in hummus format), and they will consume at least another serving of legumes which can be chickpeas or another legume), pomegranate juice (4 servings of 200ml/week) and mixed nuts (4 servings of 30 g/week). |
| Low-fat diet group | Active comparator | Other: Diet and behavioural intervention2) The low-fat diet (control diet) will be based on low consumption of fats. A low-fat diet is the most used diet for obesity treatment in adolescents. This group will not receive any additional specific food by researchers. This diet will be based on the diet proposed as low-fat diet in the PREDIMED study |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- boys and girls aged 13-17 years
- having obesity, defined as an age- and sex-specific BMI in the 95th percentile or greater (1), or great overweight (age- and sex-specific BMI in the ≥90th to <95th percentile),
- having informed consent (sign by both, one parent and the adolescent),
- and to have a mobile phone with internet access.
Key exclusion criteria (6 listed)
- having diabetes and other metabolic, endocrine and chronic disorders;
- intake of antibiotics, drug, probiotics or nutritional supplements in the last month;
- prescribed medicine to control hypertension, inflammation or dyslipidemia,
- following a prescribed diet for any reason, including weight loss, in the last 3 months;
- following a religion-restricted diet;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and behavioural interventionAlso: MEDITERRANEAN DIETIntervention will receive a specific diet designed following the characteristics of Mediterranean Diet | Other | Mediterranean diet group |
| Diet and behavioural interventionAlso: LOW-FAT DIETControl group will receive a specific diet designed following the characteristics of Low fat Diet. | Other | Low-fat diet group |
Primary outcome
Change from baseline BMI z-score at 4 months and 8 months
Time frame: "4 months" and "4 months after study cessation"
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.
18 secondary outcomes
Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline Level of physical activity at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline Habit/food intake at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline Knowledge about food and nutrition intake at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline Life quality at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Sociodemographic data of the parents one time frame
Time frame: 1 time frame
Change from baseline BMI data at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline waist circumference data at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change from baseline Waist-hip ratio data at 4 and 8 months
Time frame: "4 months" and "4 months after study cessation"
Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)
Time frame: 4 months
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Time frame: 4 months
Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)
Time frame: 4 months
Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)
Time frame: 4 months
Change of Biomarkers of insulin resistance
Time frame: 4 months
Change of biomarkers of cardiovascular risk (TMAO)
Time frame: 4 months
Change of circulating levels of glucose and blood lipid profile
Time frame: 4 months
Change of Food Intake biomarkers
Time frame: 4 months
Change of Advanced glycation end products (AGEs) related analyses
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Background: PubMed 29578661Guideline: Assessing and Managing Children at Primary Health-Care Facilities to Prevent Overweight and Obesity in the Context of the Double Burden of Malnutrition: Updates for the Integrated Management of Childhood Illness (IMCI). Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK487902/
- Background: PubMed 25310758Miller AL, Lee HJ, Lumeng JC. Obesity-associated biomarkers and executive function in children. Pediatr Res. 2015 Jan;77(1-2):143-7. doi: 10.1038/pr.2014.158. Epub 2014 Oct 13.
- Background: PubMed 28632874US Preventive Services Task Force; Grossman DC, Bibbins-Domingo K, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Obesity in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Jun 20;317(23):2417-2426. doi: 10.1001/jama.2017.6803.
- Background: PubMed 20863166Schroder H, Mendez MA, Ribas-Barba L, Covas MI, Serra-Majem L. Mediterranean diet and waist circumference in a representative national sample of young Spaniards. Int J Pediatr Obes. 2010 Dec;5(6):516-9. doi: 10.3109/17477161003777417. Epub 2010 Sep 23.
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- Individual participant dataSharing planned: Yes. The data will be shared with other researchers involved in the MED4Youth study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Caimari, PhD principal investigator
Eurecat-Reus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and behavioural intervention in people with Obesity, Adolescent and Lifestyle, Healthy, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline BMI z-score at 4 months and 8 months (time frame: "4 months" and "4 months after study cessation"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719052, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.