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临床试验/NCT06829862
NCT06829862已完成不适用

Video-Guided Lifestyle Intervention Led by Patients' Own Doctor in Overweight and Obese Adult

Cardenal Herrera University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
Body Mass Index

研究概览

简要总结

This study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

详细描述

Obesity or being overweight, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties maintaining regular exercise and/or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • •Overweight or grade I obesity (BMI > 25 and < 35).

排除标准

  • •No access to the Internet or a smartphone.
  • •Not having visited their doctor at least once in the last 2 years.
  • •Meeting DSM-IV-TR criteria for an Eating Disorder.
  • •Having a diagnosed serious psychological disorder (psychosis, bipolar disorder, major depressive disorder, substance abuse disorder, etc.).
  • •Having any disability that prevents or hinders exercise and physical activity.
  • •Receiving any weight loss treatment at another center.

研究组 & 干预措施

Own Doctor Group

Experimental

The experimental group will receive access to audiovisual instructions (exercise and nutritional education) given by their specialist doctor.

干预措施: Own Doctor Education (Other)

Unknown Doctor Group

Active Comparator

The control group will receive access to audiovisual instructions (exercise and nutritional education) given by an unknown doctor.

干预措施: Unknown Doctor Education (Other)

结局指标

主要结局

Body Mass Index

时间窗: Baseline (pre-intervention) and immediately post-intervention (3 months).

Body Mass Index (BMI) is a measure of body weight relative to height, calculated by dividing a person's weight in kilograms by the square of their height in meters.

次要结局

  • Therapeutic Alliance(Baseline (pre-intervention) and immediately post-intervention (3 months).)
  • Blood Pressure(Baseline (pre-intervention) and immediately post-intervention (3 months).)
  • Physical Activity Level(Baseline (pre-intervention) and immediately post-intervention (3 months).)
  • Adherence to the Mediterranean diet(Baseline (pre-intervention) and immediately post-intervention (3 months).)
  • Health-related Quality of Life(Baseline (pre-intervention) and immediately post-intervention (3 months).)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan F. Lisón Párraga, Dr

Chair Profesor

Cardenal Herrera University

研究点 (1)

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