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临床试验/NCT04785586
NCT04785586进行中(未招募)不适用

Effective Weight Maintenance for the Working Age - the Effectivity and Adherence of Three Web-based Weight Maintenance Interventions

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Percent of weight loss

研究概览

简要总结

This study aims to compare the effectiveness and adherence of three web-based weight management interventions, all based on the HealthyWeightCoaching (HWC) within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month web-based intervention including information and exercises to promote weight loss. Each patient is allocated a personal coach to encourage progress on the platform.

In the current setting, the investigators study how minimal added support will affect the effectiveness and adherence of the web-based program. The patients are randomized into three groups all of which include the HWC platform. In addition, group 1 will be offered three individual face-to-face sessions via video and group 2 three group face-to-face sessions via video. Group 3 acts as the control group offering the basic HWC protocol.

The patients (target n=120) are enrolled from the occupational health of the city of Helsinki.

详细描述

Obesity is one of the major public health problems globally, affecting an ever-increasing proportion of working age adults. In addition of increasing the risk of many obesity-associated diseases, obesity is associated to impaired ability to work, making it a relevant occupational health concern. Treatment of obesity requires long-term interventions, but nevertheless, it is challenging to provide long-term treatment when resources in real-life health care systems are limited. To that need, new cost-effective and accessible intervention methods are created. One of these is the a real-life web-based obesity management program HealthyWeightCoaching (HWC).

HWC has shown promising results in obesity management, but alike in other fully virtual interventions, one of the challenges has been adherence. Creating hybrid-models by addition of face-to-face contacts to the web-based structure, has been shown to improve adherence and therefore the effectiveness of the intervention. However, data on hybrid interventions for weight management is still scarce and calls for further research.

In the current setting, the investigators study how minimal added support will affect the effectiveness and adherence of the web-based program. The patients are randomized into three groups all of which include the HWC platform. In addition, group 1 will be offered three individual face-to-face sessions via video and group 2 three group face-to-face sessions via video. Group 3 acts as the control group offering the basic HWC protocol.

Data on health and lifestyle are collected at 0, 6, 12 month time points. The 12-month intervention is followed by a 5 year monitoring period. The data collection includes questionnaires, measurements and laboratory tests.

The patients (target n=120) are enrolled from the occupational health of the city of Helsinki. The participation is free for the patient.

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
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
是

入选标准

  • •working age
  • •body mass index (BMI) 30-40 kg/ m²
  • •the possibility to use a computer and /or a smartphone with access to the internet
  • •willingness to participate in the treatment program
  • •sufficient Finnish language

排除标准

  • •diagnosed severe illness (incl. mental illnesses)
  • •pregnancy or breastfeeding
  • •simultaneous participation in another weight loss program
  • •remarkable changes in weight (+/- 5kg) in the past 3 months
  • •bariatric operation (past or upcoming)

研究组 & 干预措施

Individual

Experimental

HWC protocol + three individual "face-to-face" sessions via video

干预措施: Healthy Weight Coaching (Behavioral)

Individual

Experimental

HWC protocol + three individual "face-to-face" sessions via video

干预措施: Individual meetings (Behavioral)

Group

Experimental

HWC protocol + three "face-to-face" group sessions via video

干预措施: Healthy Weight Coaching (Behavioral)

Group

Experimental

HWC protocol + three "face-to-face" group sessions via video

干预措施: Group meetings (Behavioral)

Control

Active Comparator

Standard HWC protocol

干预措施: Healthy Weight Coaching (Behavioral)

结局指标

主要结局

Percent of weight loss

时间窗: baseline to 24 months

Mean weight change in percent

次要结局

  • Categorical weight loss(baseline to 24 months)
  • Psychological Flexibility(baseline to 24 months)
  • Perceived working ability(baseline to 24 months)
  • Glucose metabolism(baseline to 24 months)
  • Lipid metabolism(baseline to 24 months)
  • Eating behaviour(baseline to 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsi Pietiläinen

Professor in Clinical Metabolism

Helsinki University Central Hospital

研究点 (1)

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