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临床试验/NCT02308176
NCT02308176Unknown不适用

Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (Diet and Sport) in a Population of Patients Obese or Overweight Adults Patients

Basque Health Service6 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
107
试验地点
6
主要终点
weight reduction

研究概览

简要总结

INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI> = 25 mg / kg
  • Holder smartphone
  • Sign informed consent

排除标准

  • Presence of physical or mental illnesses that prevent the realization of physical activity
  • Be participating in another research project
  • Pregnancy or lactation
  • Patients who are on diet or drug treatment for weight loss
  • History of myocardial infarction or stroke

结局指标

主要结局

weight reduction

时间窗: at 6 months

reduction of weight

次要结局

  • smoking cessation(at 6 and 12 months)
  • waist circumference(at 6 and 12 months)
  • BMI(at 6 and 12 months)
  • blood pressure(at 6 and 12 months)
  • satisfaction(at 12 months)
  • heart rate(at 6 and 12 months)
  • plasma cholesterol(at 12 months)
  • index of physical exercise(at 12 months)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Antxon Apiñaniz Fernández de LArrinoa

MAIN RESEARCHER

Basque Health Service

研究点 (6)

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