An interventional study of Energy2MOB in Mediterranean Diet, Overweight or Obese Adults and Exercise Therapy, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Supportive care
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Among 387 studies in Obesity with a site in Spain — 92 open to participants now, 131 under way, 43 of them phase 3. Obesity · Spain.
Among the 387 studies in Obesity with a site in Spain, this one is the 153rd largest by planned enrollment of the 329 interventional ones that give a count, is one of 52 that started in 2025, is one of 219 with no phase, reaches primary completion later than 35 of the 130 other live ones, and was the 286th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →92 of the 387 studies in Obesity with a site in Spain are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Spain, United States, Brazil and 7 more countries
Ages 18+
Eli Lilly and Company · Sites in Spain, United States, Belgium and 7 more countries
Ages 6–11
AstraZeneca · Sites in Spain, United States, Argentina and 13 more countries
Ages 18+
Novo Nordisk A/S · Sites in Spain, United States, Belgium and 7 more countries
Ages 18+
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Sites in Spain
Ages 18–65
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
387 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 24 · Phase 3 79 · Phase 4 7
First in 2001; this study’s year is marked. 52 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 136 is above the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 123 across the 329 interventional studies, 128 across the 57 observational. Of the 208 that completed or were terminated, 26 (13%) have results posted.
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119 of 387 have an industry lead sponsor. The 10 most frequent:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina has 6 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
32 of the studies in Obesity with a site in Spain that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07332273Phase 3Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludLevothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity. | 2026-11 |
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06672549Phase 3Eli Lilly and CompanyA Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) | 2027-02 |
Add all 32 to your calendar (.ics) → With an account.
Among the 387 studies in Obesity with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background: Obesity is a prevalent multifactorial disease worldwide and has become a significant public health concern. The latest data from the 2022 Catalonia Health Survey show that 56.2% of men and 43.7% of women are overweight or obese, and 39% of children aged 6 to 12 years have excess weight. Excess adiposity poses a health risk as it is associated with various chronic diseases such as type 2 diabetes mellitus, hypertension, and dyslipidaemia, all of which affect quality of life and increase mortality risk.
Hypothesis: The Energy2MOB obesity management programme in Berguedà is a group-based intervention incorporating nutrition education and physical activity. It aims to reduce excess body weight and the risk of chronic diseases, including type 2 diabetes mellitus, dyslipidaemia, and hypertension, through a multicomponent approach that enhances dietary habits, physical activity, and emotional eating regulation.
Objectives
Methodology: A randomised clinical trial with two groups (control and intervention) over one year, including individuals aged 18-65 years in the Berguedà health region with overweight grade II (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²). Exclusion criteria include significant language barriers, previous bariatric surgery, moderate to severe cognitive impairment, and severe psychiatric disorders preventing participation in sessions. Participants must attend at least 80% of the programme.
Measurements
Statistical Analysis: Accepting an alpha risk of 0.05 and a statistical power above 0.8 in a bilateral contrast, 68 subjects per group are required to detect a difference of at least 2.5 kg. A common standard deviation of 4.77 is assumed, with an estimated 15% dropout rate. Sample size calculations were performed using GRANMO version 8.0 (https://www.datarus.eu/ca/aplications/granmo/; consulted in November 2024).
Expected Outcomes, Applicability, and Relevance: This study aims to generate scientific evidence on the effectiveness of multicomponent group-based interventions focused on improving nutrition, physical activity, and psychological well-being in obesity and chronic disease management. It seeks to create an environment that facilitates behavioural changes, leading to weight reduction and improved quality of life. The findings will also contribute to the development of a practical guide for addressing excess weight in primary healthcare settings.
Keywords (maximum 6): Adult obesity, primary health care, group interventions, dietary interventions, multicomponent interventions, Mediterranean diet.
BACKGROUND AND CURRENT STATE OF THE TOPIC Obesity is a chronic, complex, and prevalent disease worldwide, posing a significant public health concern with high socio-economic costs. The World Health Organization (WHO) defines it as an abnormal or excessive accumulation of fat that impairs health, promotes medical complications, and reduces life expectancy.
Recent studies indicate that obesity prevalence has risen in recent years and is projected to continue increasing. According to a recent study by the Carlos III Health Institute in collaboration with the Spanish Agency for Food Safety and Nutrition (AESAN) and regional health services, 55.8% of adults are overweight (63.7% of men and 48.4% of women), and 18.7% have obesity (19.3% of men and 18.0% of women). Among children and adolescents, 10.7% have obesity, and 30% are overweight. More specifically, the 2022 Catalonia Health Survey reports that half of the population aged 18-74 years has excess weight, including overweight and obesity, with 56.2% of men and 43.7% of women affected. Among children aged 6-12 years, nearly 39% have excess body weight, with 25.2% classified as overweight and 13.7% as obese.
There is no doubt that modern society fosters an obesogenic environment, promoting sedentary lifestyles and unhealthy diets dominated by processed foods. However, additional factors predispose individuals to excess weight even without exposure to these obesogenic influences. Obesity is a multifactorial disease, involving both intrinsic (non-modifiable) factors such as genetics and physiological causes and extrinsic (modifiable) factors such as environmental, psychological, social, economic, and political influences.
Physiopathologically, obesity is characterised by chronic low-grade inflammation due to adipose tissue dysfunction caused by excessive and/or abnormal fat accumulation. Excess adiposity is a major health risk as it is associated with a broad range of chronic diseases, including cardiovascular disease, type 2 diabetes mellitus, certain cancers, mental health disorders, chronic kidney disease, musculoskeletal complications, respiratory diseases, and non-alcoholic fatty liver disease (NAFLD). Addressing this issue with evidence-based solutions is urgent and a public health priority.
Expert groups, including the National Institutes of Health, WHO, the Academy of Nutrition and Dietetics, and the Spanish Society for the Study of Obesity (SEEDO), recommend a 5-10% reduction in initial body weight over six months to achieve health benefits and manage obesity-related comorbidities. Such weight loss is associated with reductions in body mass index (BMI), waist circumference, and fat mass, alongside significant improvements in glucose levels, lipid profile, and blood pressure. Consequently, obesity reduction strategies offer substantial benefits for chronic disease management, particularly type 2 diabetes mellitus, dyslipidaemia, and hypertension.
Beyond its impact on physical health, obesity also affects emotional, psychological, and social well-being. Weight-related stigma, discrimination, and bias contribute to decreased quality of life and increased obesity-related comorbidities. Current scientific evidence highlights that body weight regulation is not solely under voluntary control, as biological, genetic, and environmental factors play fundamental roles in obesity development and maintenance. Ineffective weight loss outcomes, insufficient multidisciplinary coordination, a lack of human and economic resources for obesity management, and societal misperceptions about obesity-particularly in lower socioeconomic groups-contribute to the overburdening of healthcare systems, preventing comprehensive and high-quality patient care.
Therefore, obesity treatment must adopt a holistic approach to achieve long-term health and well-being improvements. The focus should shift from mere weight reduction to sustainable lifestyle changes, including dietary modifications, increased physical activity, and psychological well-being improvements. Effective intervention requires a multidisciplinary team of specialists (e.g., dietitians-nutritionists, physicians, nurses, psychologists, and physical activity experts) working collaboratively to enhance patient health and well-being.
More specifically, interventions should promote a well-balanced diet alongside regular physical activity and behavioural therapy to sustain long-term lifestyle changes. The Mediterranean diet, a well-established cardioprotective dietary model in the region, serves as the basis for this approach. It emphasises a high intake of natural plant-based fats (extra virgin olive oil and nuts), minimally processed plant-based foods (vegetables, fruits, legumes, and whole grains), limited meat consumption (especially red and processed meats), moderate fish and egg consumption, and minimal intake of ultra-processed foods high in saturated fats, trans fats, and added sugars.
Regular physical activity and exercise are crucial in obesity treatment as they enhance weight loss, reduce abdominal fat, support weight maintenance, improve well-being, and positively impact cardiovascular risk factors. Psychological therapy plays an essential role, incorporating motivational strategies, problem-solving techniques, stimulus control, and stress reduction techniques. The COM-B behaviour change model will underpin the multicomponent group education intervention, ensuring participant motivation and engagement throughout all obesity treatment phases-critical for achieving successful outcomes.
Although several scientific studies have demonstrated the effectiveness of lifestyle modification-based group interventions, their implementation in primary healthcare settings remains limited due to a shortage of trained professionals with adequate availability. This highlights the need for resource allocation to address the issue effectively. Developing and implementing specific programmes based on a collaborative and interdisciplinary care model is crucial for successfully managing obesity and its associated health consequences. Such initiatives could improve the prevalence of cardiometabolic risk factors in affected individuals.
In 2021, the Catalan primary healthcare system incorporated dietitians-nutritionists through the Programme for the Promotion of Healthy Eating and the Prevention and Management of Diseases in Primary and Community Healthcare. These professionals focus on preventing and treating nutrition-related health issues by promoting healthy and sustainable eating habits tailored to individual conditions, risks, diseases, preferences, and socio-economic and cultural circumstances, with a particular focus on vulnerable populations. Additionally, primary healthcare introduced other roles, such as emotional well-being and community health specialists and physiotherapists, to facilitate the implementation of such programmes.
This project builds on prior obesity management interventions in primary healthcare settings, incorporating insights from past participants to refine and enhance its effectiveness. It has the potential to generate robust evidence on the effectiveness of multicomponent group-based interventions for obesity and chronic disease management in adults, providing a supportive environment that fosters sustainable behaviour change for improved patient quality of life and optimal health outcomes. If the intervention proves successful, a practical guide will be developed for broader implementation across primary healthcare centres addressing adult obesity.
HYPOTHESIS Participation in the Energy2MOB group education programme for obesity management in Berguedà will lead to a reduction in body weight among individuals with overweight or obesity. Additionally, it will improve dietary habits, physical activity levels, and emotional eating behaviour, while also supporting the management of chronic diseases such as type 2 diabetes mellitus, dyslipidaemia, and hypertension.
OBJECTIVES Primary Objectives (PO)
Secondary Objectives (SO)
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
This study's planned enrollment of 136 is above the median of 67 across 9,010 interventional studies indexed under Obesity.
Browse Obesity studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà: Baix Berguedà (Puig-Reig CAP), Berga Centre (Berga CAP), Alt Berguedà (Guardiola de Berguedà CAP) The programme will include: * One pre-intervention visit * 8 weekly group sessions * One post-intervention visit * One-month telephone follow-up * In-person follow-ups at three and six months
Other: Energy2MOB
The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions.
Intervention: The Energy2MOB programme will take place at three primary healthcare centres in Berguedà: Baix Berguedà (Puig-Reig CAP) Berga Centre (Berga CAP) Alt Berguedà (Guardiola de Berguedà CAP) The programme will include: One pre-intervention visit 8 weekly group sessions One post-intervention visit One-month telephone follow-up In-person follow-ups at three and six months The control group will continue with standard care at their usual primary healthcare centre and will only attend pre-intervention, post-intervention, and six-month follow-up visits. They will not receive group sessions or telephone follow-ups. If the Energy2MOB programme proves effective, control group participants will be invited to participate in the intervention sessions.
Body weight changed
Body weight changed refers to the process of losing body weight, typically through a combination of diet, exercise, and lifestyle changes. It is aimed at changing excess body fat, improving health, and achieving a healthier body composition. This changed can vary depending on the individual's goals, metabolic rate, and overall health.
Time frame: 1 year
Body weight
Calibrated scale, measured with light clothing and without shoes, in kilograms
Time frame: 1 year
Height
With stadiometer, mesured in metres
Time frame: 1 year
Waist circumference
Measured at the level of the navel using a flexible measuring tape, in centimetres
Time frame: 1 year
BMI (Body Mass Index)
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 1 year
Obesity-Related Comorbidities
Hypertension, dyslipidaemia/hypercholesterolaemia, type 2 diabetes mellitus, Fibromyalgia, cardiovascular disease, sleep apnoea syndrome, Osteoarticular pathology, non-alcoholic fatty liver disease (NAFLD), urinary incontinence
Time frame: 1 year
Medication Use
Medication used for comorbidities associated with obesity refers to drugs prescribed to manage health conditions that often occur alongside obesity, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. These medications help control the symptoms and prevent further complications related to these comorbidities.
Time frame: 1 year
Blood Pressure (systolic and diastolic)
Blood pressure refers to the force exerted by circulating blood on the walls of blood vessels. It is measured in two values: systolic and diastolic. Systolic blood pressure is the higher number and represents the pressure in the arteries when the heart contracts and pumps blood. Diastolic blood pressure is the lower number and measures the pressure in the arteries when the heart is at rest between beats. Normal blood pressure is typically around 120/80 mmHg. Blood pressure higher than 130/80 mmHg is considered elevated or high, which can increase the risk of cardiovascular diseases, strokes, and kidney problems. Monitoring and managing blood pressure is essential for maintaining overall health, particularly in individuals with obesity or other risk factors.
Time frame: 1 year
Fasting plasma glucose
Plasma glucose refers to the concentration of glucose (sugar) in the liquid component of blood. It serves as a primary energy source for the body's cells. Measuring plasma glucose is essential for diagnosing and monitoring metabolic conditions such as diabetes mellitus. Normal fasting levels typically range between 70 and 100 mg/dL.
Time frame: 1 year
Glycated haemoglobin (HbA1c)
Glycated haemoglobin (HbA1c) reflects the average blood glucose levels over the past two to three months. It forms when glucose binds to hemoglobin in red blood cells. HbA1c is widely used to diagnose and monitor diabetes. Normal values are generally below 5.7%, with higher levels indicating poor long-term glucose control.
Time frame: 1 year
Smoking status
Current smoker, former smoker, non-smoker
Time frame: 1 year
Cardiovascular risk
Assessed using validated risk score tools, REGICOR calculator. TABLES FOR CALCULATING 10-YEAR CORONARY RISK: \<5% Low risk, 5-9.9% Moderate risk, 10-14.9% High risk, ≥15% Very high risk
Time frame: 1 year
Mediterranean diet adherence
Adherence to the Mediterranean diet through the validated MEDAS questionnaire: \<9 low adherence, \>= 9 good adherence
Time frame: 1 year
Dietary habits evaluation
Eating behaviour questionnaire
Time frame: 1 year
Physical activity level
International Physical Activity Questionnaire (IPAQ) short version. Results: * Low. They do not record physical activity, or they record it but it does not meet the medium or high categories. * Medium. Considers the following criteria: 3 or more days of vigorous physical activity of at least 20 minutes per day. 5 or more days of moderate-intensity physical activity or walking of at least 30 minutes. 5 or more days of any combination of light, moderate, or vigorous physical activity that reach a record of 600 METs-min/week. * High. This is a high category and meets the following requirements: 3 or more days of vigorous physical activity or that accumulate 1,500 METs-min/week. 7 or more days of any combination of light, moderate, or vigorous physical activity that reach a record of 3,000 METs-min/week.
Time frame: 1 year
Emotional eating assessment
Emotional Eating Questionnaire (CCE) Garaulet. Scale scores: unemotional eater 0 to 5, mildly emotional eater 6 to 10, emotional eater 11 to 20, and highly emotional eater 21 to 30 points.
Time frame: 1 year
Health-related quality of life
EuroQol-5D (EQ-5D) with Visual Analogue Scale (VAS): Improvement in Health-Related Quality of Life (HRQoL) after the intervention: an improvement in HRQoL is considered if there is a decrease in the EuroQol (EQ-5D) questionnaire score compared to the baseline. A set of values consists of weights that convert each EQ-5D health profile into a value on a scale anchored between 1 (meaning complete health) and 0 (meaning a condition as serious as death).
Time frame: 1 year
Programme adherence
Based on participant attendance records
Time frame: 1 year
Intervention fidelity
Nomber of participants with completion of planned activities in each session
Time frame: 1 year
Programme satisfaction
Participant feedback survey
Time frame: 1 year
Total cholesterol
Total cholesterol measures the overall amount of cholesterol in the blood, including LDL (bad), HDL (good), and other lipid components. It is an important marker for cardiovascular health. High levels are associated with an increased risk of heart disease and stroke. Desirable values are generally below 200 mg/dL.
Time frame: 1 year
HDL cholesterol
HDL cholesterol (high-density lipoprotein) is known as the "good" cholesterol because it helps remove excess cholesterol from the bloodstream. Higher HDL levels are associated with a lower risk of cardiovascular disease. It plays a protective role in heart health. Optimal levels are typically above 60 mg/dL.
Time frame: 1 year
LDL cholesterol
LDL cholesterol (low-density lipoprotein) is often referred to as the "bad" cholesterol because high levels can lead to plaque buildup in the arteries, increasing the risk of cardiovascular disease. It is a key marker in assessing heart health. Optimal levels are typically below 100 mg/dL.
Time frame: 1 year
Triglycerides
Triglycerides are a type of fat (lipid) found in the blood, used by the body for energy. High levels can increase the risk of cardiovascular disease, especially when combined with low HDL or high LDL cholesterol. Normal fasting levels are typically below 150 mg/dL.
Time frame: 1 year
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) is an enzyme primarily found in the liver that helps convert proteins into energy for liver cells. Elevated ALT levels in the blood may indicate liver damage or inflammation. Normal values typically range from 7 to 56 U/L.
Time frame: 1 year
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) is an enzyme found in the liver, heart, muscles, and other tissues. It plays a role in amino acid metabolism. Elevated AST levels can indicate liver injury or damage to other organs. Normal levels usually range from 10 to 40 U/L.
Time frame: 1 year
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase (GGT) is an enzyme primarily found in the liver and bile ducts. It is involved in the metabolism of glutathione and the transport of amino acids. Elevated GGT levels are commonly used as a marker of liver disease, alcohol consumption, or bile duct obstruction. Normal values typically range from 0 to 30 U/L.
Time frame: 1 year
Creatinine
A waste product produced by muscles from the breakdown of creatine. It is filtered by the kidneys, and elevated levels in blood can indicate impaired kidney function.
Time frame: 1 year
Glomerular Filtration Rate (GFR)
A measure of kidney function that indicates how well the kidneys are filtering waste from the blood. It is calculated based on factors like age, sex, and creatinine levels.
Time frame: 1 year
C-reactive Protein (CRP)
A protein produced by the liver in response to inflammation. High levels of CRP in the blood can indicate inflammation or infection in the body.
Time frame: 1 year
Plan to share: No
Start is estimated for Jun 2025; primary completion for Mar 2026, 9 months later.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 9 months is below that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina →