Pilot Study of the " Cerdanya on Fitness" Program to Promote the Physical Exercise, Healthy Nutritional Habits and Psycho-emotional Well-being of Obese People in Cerdanya. Pilot Study of the "Cerdanya on Fitness" Program to Promote Physical Exercise, Healthy Nutritional Habits and Psychoemotional Well-being of People With Obesity in Cerdanya.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of fat mass percentage with a bioimpedance scale
研究概览
简要总结
To evaluate the effectiveness of an intervention program called "Cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing
详细描述
Previous phase:Presentation of the protocol to doctors and nurses of the primary health care center.
Phase 1: After being informed about the study and the possible risks, all patients who give their written informed consent will undergo.
-1) 4 weeks of screening to determine eligibility to enter the study. Referral of patients who meet the inclusion/exclusion criteria to enter the Cerdanya on fitness program by the nursing consultation.
Phase I protocol data collection (physical activity scale, positive mental health scale, Mediterranean diet scale, sociodemographic variables will also be collected week 0) Patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks)
weeks 1-2: Initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years
- •Body Mass Index 30-40
排除标准
- •Serious cognitive impairment
- •Serious mental disorder
- •Impossibility of performing physical activity for medical diagnosis (IAM < 3 months, hemorrhagic stroke < 3 months, major surgery < 3 months)
- •Severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)
结局指标
主要结局
Change from baseline of fat mass percentage with a bioimpedance scale
时间窗: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Change from baseline of fat free mass percentage with a bioimpedance scale
时间窗: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Change from baseline of frecuency and intensity of pysical activity
时间窗: 9 months
CLASS AF is a rapid classification scale for physical activity. It is measured based on physical activity at work and physical activity in leisure time, taking into account minutes and frequency. From the formula: 2 x L + Ll x frq 2, the person is classified as sedentary, minimally active, mildly active, moderately active or very active.
Change from baseline mediterrainian diet on 14 points on the scale of adherence to the Mediterranean diet.
时间窗: 9 months
The scale of adherence to the Mediterranean diet, is a scale based on 14 items where you ask about 7 groups of foods and portions characteristic of this diet. each item must score with a 1 or 0 depending on the fulfilled or not. The sum of the points if it is less than 9 indicates a bad grip if it is equal to or greater than 9 , a good grip
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
时间窗: 9 months
The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
change in the baseline of the caryovascular risk index with the waist-hip measurement
时间窗: 9 months
The waist-hip ratio (IC-C) is a specific anthropometric measurement to measure the levels of intra-abdominal fat, it relates the perimeter of the waist to that of the hip (in centimeters) and depending on the result it is estimated if there is a certain cardiovascular risk. The WHO establishes normal levels of 0.8 in women and 1 in men; higher values would indicate
Change from baseline of bone percentage on anthropometric measurements
时间窗: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 diameters. The percentage of bone is determined from specific formulas.(F Rocha) Mesured in kg and percentage
Change from baseline of the BMI of participants. Weight and height will be combined to report BMI in kg/m^2
时间窗: 2 months
Weigh will be mesured with a analogic weighing machine in Kilograms. Participants are mesured only with underwear clouths. Height will be mesured in m\^2.
Change from baseline of watter percentage with a bioimpedance scale
时间窗: 2 months
Participants are mesured only with underwear clouths on the bioimpedance scale TANITA BC 602
Change from baseline of muscle percentage and muscle kg on anthropometric measurements
时间窗: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 perimeters (triceps muscles, calf muscles, quadriceps muscles) . The percentage of muscle is determined from specific formulas.( F Lee) mesured in kg and percentage
Change from baseline of fat percentage and fat Kg on anthropometric measurements
时间窗: 9 months
The specific anthropometric measurements for people with obesity according to ISAK are 3 skin folds mesured in mm 3 diameters and 2 perimeters (.Waist circumference 1: at rib height, waist circumference 2: 2 cm above the navel. The percentage of fat is determined from specific formula. (F Weltman) Mesured in kg and percentage
Change from baseline of glucose and cholesterol on blood test
时间窗: 9 months
Test levels of HDL, LDL, Triglicerids, Cholesterol Total. Mesured in mg/dL
次要结局
未报告次要终点
研究者
Marta Prats Arimon
Principal Investigator
University of Barcelona