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临床试验/NCT04003259
NCT04003259已完成不适用

Comprehensive Lifestyle Management Programme in the Treatment of Obesity: the Get-a-Grip (GAG) Study

Tampere University2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2009年1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
已完成
入组人数
134
试验地点
2
主要终点
Change in waist circumference (cm)

研究概览

简要总结

The primary aim of this study was to examine weight reduction in primary care in obese or overweight subjects with a comorbidity that would benefit from weight loss during 1-year comprehensive lifestyle management programme including medical examinations, personalized dietary and exercise advice, guidance on shopping behaviour and food preparation, and group discussions.

详细描述

Obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure (BP) increasing the risk of cardiovascular morbidity and mortality. Obesity-induced complications are increasingly encountered in the health care system and especially in primary care. Thus, there is a growing need for individually tailored weight management programs aiming to permanent lifestyle and dietary changes for the prevention and treatment of obesity-related health hazards.

The study investigated weight reduction during 1-year comprehensive lifestyle programme in 134 obese or overweight subjects (BMI>30, or BMI>25 with a comorbidity including diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). The participants were recruited from the local diabetes centre and health care providers. The programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on cooking classes by a professional chef, examinations by a medical doctor, and group discussions. The efficacy of the program was followed by measuring change in weight, BMI, waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic BP.

The study protocol has been approved by the ethics committee of the Pirkanmaa Hospital District (R12099).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)

排除标准

  • physical condition that prevented exercise
  • abuse of alcohol or drugs
  • medical history suggesting poor adherence
  • severe concurrent disease
  • moderate to severe dementia

研究组 & 干预措施

Overweight and obese subjects

Experimental

1-year lifestyle programme

干预措施: Lifestyle management programme (Behavioral)

结局指标

主要结局

Change in waist circumference (cm)

时间窗: baseline, and months 2-3, 5-6, and 11-12

Waist circumference was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

Change in weight (kg)

时间窗: baseline, and months 2-3, 5-6, and 11-12

Weight was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

Change in body mass index (BMI) (kg/m^2)

时间窗: baseline, and months 2-3, 5-6, and 11-12

BMI was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

Change in muscle mass and body fat (percentage points)

时间窗: baseline, and months 2-3, 5-6, and 11-12

Muscle and fat percentage were measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

Change in systolic and diastolic blood pressure (mmHg)

时间窗: baseline, and months 2-3, 5-6, and 11-12

Blood pressure was measured at baseline (month 0), and after 2-3, 5-6, and 11-12 months.

次要结局

  • Fitness index(All participants were invited to a two-kilometer walk-test at baseline (month 0) and month 11-12)

研究者

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

Ilkka Pörsti, MD

Clinical Professor

Tampere University

研究点 (2)

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