ENERGY2MOB STUDY: OBESITY MANAGEMENT IN BERGUEDÀ

NCT06988904 | Not Yet Recruiting

• 1 other identifier: 24/303-P
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

• Assess the effectiveness of the Energy2MOB programme in reducing body weight by 5-10% among adults with obesity in the Berguedà health region.
• Measure lifestyle modifications, including dietary habits, physical activity, and emotional eating. 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
• Sociodemographic factors: sex, age, education level, marital status, employment status.
• Lifestyle factors: alcohol and tobacco use, dietary habits, physical activity, emotional eating, health-related quality of life.
• Anthropometric parameters: body weight, height, BMI, waist circumference.
• Blood pressure, medication use, biochemical parameters (fasting glucose, glycated haemoglobin, lipid profile, liver and kidney function markers, C-reactive protein). 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.

Conditions

Mediterranean Diet; Overweight or Obese Adults; Exercise Therapy; Cardiovascular Diseases; Psychological Well Being

Keywords

obesity and overweight; primary health care; Mediterranean diet; dietary interventions

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (29)

• Body weight

  1 year

• Height

  1 year

• Waist circumference

  1 year

• BMI (Body Mass Index)

  1 year

• Obesity-Related Comorbidities

  1 year

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Energy2MOB OTHER

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.

Interventional group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 years
• Overweight (BMI 27-30 kg/m²) or obesity (BMI 30-40 kg/m²)
• Availability to attend at least 80% (6 out of 8) of the group sessions

You may not qualify if:

• Significant language barriers (unable to communicate in Catalan or Spanish)
• Previous bariatric surgery
• Moderate to severe cognitive impairment
• Severe psychiatric disorders preventing participation in group sessions

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Manresa, Spain, Manresa, Barcelona 08242

Manresa, Barcelona, 08242, Spain

Location

Related Publications (21)

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• Gargallo-Civil M, Ruiz-Comellas A, Sola L, Vaque-Crusellas C. Energy2MOB study, group food education programme to reduce obesity in adults: randomised clinical trial protocol. BMJ Open. 2025 Dec 21;15(12):e108028. doi: 10.1136/bmjopen-2025-108028.

  PMID: 41423297 DERIVED

MeSH Terms

Conditions

Overweight; Cardiovascular Diseases; Psychological Well-Being; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Central Study Contacts

Mar Gargallo Civil

CONTACT

+34 660274434; mgargallo.cc.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: May 25, 2025
• Study Start: June 7, 2025
• Primary Completion: March 7, 2026
• Study Completion: March 7, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)