EFFECTIVENESS OF THE GROUP-BASED NUTRITION EDUCATION PROGRAMME FOR OBESITY MANAGEMENT IN BERGUEDÀ: A RANDOMISED CLINICAL TRIAL. ENERGY2MOB STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Body weight changed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Interventional group
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
干预措施: Energy2MOB (Other)
Control group
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.
结局指标
主要结局
Body weight changed
时间窗: 1 year
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.
次要结局
- Body weight(1 year)
- Height(1 year)
- Waist circumference(1 year)
- BMI (Body Mass Index)(1 year)
- Obesity-Related Comorbidities(1 year)
- Medication Use(1 year)
- Blood Pressure (systolic and diastolic)(1 year)
- Fasting plasma glucose(1 year)
- Glycated haemoglobin (HbA1c)(1 year)
- Smoking status(1 year)
- Cardiovascular risk(1 year)
- Mediterranean diet adherence(1 year)
- Dietary habits evaluation(1 year)
- Physical activity level(1 year)
- Emotional eating assessment(1 year)
- Health-related quality of life(1 year)
- Programme adherence(1 year)
- Intervention fidelity(1 year)
- Programme satisfaction(1 year)
- Total cholesterol(1 year)
- HDL cholesterol(1 year)
- LDL cholesterol(1 year)
- Triglycerides(1 year)
- Alanine aminotransferase (ALT)(1 year)
- Aspartate aminotransferase (AST)(1 year)
- Gamma-glutamyl transferase (GGT)(1 year)
- Creatinine(1 year)
- Glomerular Filtration Rate (GFR)(1 year)
- C-reactive Protein (CRP)(1 year)
研究者
Anna Ruiz Comellas
Principal Investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina