跳至主要内容
临床试验/NCT03351712
NCT03351712招募中不适用

ACTonHEALTH Study Protocol: Promoting Psychological Flexibility With Activity Tracker and mHealth Tools to Foster Healthy Lifestyle for Obesity and Other Chronic Health Conditions

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Physical Activity directly measured by wearable devices Daily STEPS Count

研究概览

简要总结

Obesity and overweight are growing steadily and becoming a global epidemic. Recent researches report a 64% of the adult population as overweight. The social and economical impact is increasing and the most of the rehabilitation programs, while effective in the short term, do not produce long lasting results. From a behavioral perspective an explanatory model can describe the phenomena with the lack of sources of reinforcement related to healthy habits in the daily-life context. The goal of this project, combining Acceptance and Commitment Therapy and Wearable Technology, is to develop an effective intervention, efficient and sustainable, which continues after ending of the hospitalization, providing adequate contingencies of reinforcement in the natural environment, integrating systematic measurements, continuous feedbacks and individualized, values-based objectives. Related goal-setting show a shift from results linked with weight loss towards action connected with healthy life-style.

详细描述

Background The condition of being overweight is an increasing problem worldwide, becoming an epidemic both in Europe and in the United States. Recent estimates that over 60% of adults are overweight and at the same time obesity affects around 35% of the population. In the US the cost of the health system to cope with obesity and related diseases now exceeds the sum of 100 billion and in Europe costs are currently similar. Health risks related to being overweight include psychological difficulties, depression and stigma, physical problems and heart diseases, cancer and respiratory diseases not to mention musculoskeletal and metabolic problems.

Obesity is a chronic health condition, but is also a major risk factor for various diseases both chronic and acute. This problem is currently steadily rising, with prevalence data and epidemiological estimates that should be of great concern. Despite strong biological components and hereditary aspects, obesity is primarily linked to incorrect habits of everyday life, mainly eating habits and physical activity. Numerous studies have documented that regular physical activity and wise choices in food uptake can prevent obesity and related conditions.

The main challenge in addressing obesity and associated disorders is represented by developing and making available and sustainable comprehensive programs that include combinations of physical activity, dietary aspects and psychological interventions.

Interventions developed in this way, including dietary education protocols, physical rehabilitation and exercises programs, nutritional, endocrinological, psychological, surgical and pharmacological treatments are mainly effective in the short term, despite many of which are characterized by high costs and several periods of hospitalization. The analysis of the literature suggests the superiority of intensive multidisciplinary interventions: health protocols, dietary programs, psychological and physical rehabilitation. One of the problems of such interventions is that they are often only possible during an hospitalization period, with high costs associated. However, despite good evidence of effectiveness, the long-term results are generally limited.

In general, availability, costs, compliance and long-term efficacy are important limitations to this variety of approaches. Frequently obese individuals regain about 30% of the weight they lost within the first year. After only 3 years they are returning to pre-treatment weight. Psychological intervention are generally assumed to be one of the core parts in the treatment aimed to obesity. In particular, Cognitive-Behavioral interventions, usually within multidisciplinary paths and rarely implemented individually, are generally considered the gold-standard for addressing the epidemic of obesity, or "globesity".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 70 years;
  • obesity according to the WHO criteria (BMI ≥ 30); ù
  • written and informed consent to participate, 4) tech-friendly to receive feedback through smartphone, mail and wearable devices

排除标准

  • other severe psychiatric disturbance diagnosed by DSM-V criteria;
  • severe visual difficulties,
  • important limitations of movement, in particular subjects for which it is not recommended physical activity,
  • concurrent medical condition not related to obesity. DSM-V (Thomas et al., 2014) will be used as screening tools for psychiatric disorders.

结局指标

主要结局

Physical Activity directly measured by wearable devices Daily STEPS Count

时间窗: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

Daily Steps directly collected by wearable devices

次要结局

  • Acceptance & Action Questionnaire AAQ-II(Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)
  • International Physical Activity Questionnaires (IPAQ-SF)(Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)
  • MDS - Mediterranean Diet Score(Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)
  • PGWBI - Psychological General Well-Being Index(Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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