Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
2016年5月20日 更新者:Rolando Giovanni Díaz Zavala、Universidad de Sonora
Translational Study for Overweight and Obesity Management in Adults Using the "Group Lifestyle Balance Program" in Primary Care Clinics and Public Hospitals From Sonora, México
Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico.
Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity.
These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol.
In Mexico most primary care clinics and public hospitals apply traditional treatments for obesity management, which have limited effect on weight loss.
This study would provide scientific evidence for an effective model for obesity management.
Objective.
The purpose of this study is to evaluate the effectiveness of the "Group Lifestyle Balance Program" for overweight and obesity management in adults, in primary care clinics and public hospitals from Sonora.
This is a translational clinical study.
Healthcare providers from the participating clinics will be trained with the Group Lifestyle Balance Program before its implementation.
The primary outcome measurement is the change in body weight from baseline to 6 months and 12 months.
Changes in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in patients receiving the program before and 6 and 12 months after starting the program.
Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase (AST), Alanine Aminotransferase (ALT)] will be evaluated from baseline to 12 months.
研究概览
研究类型
介入性
注册 (实际的)
258
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Sonora
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Hermosillo、Sonora、墨西哥、83000
- Centro de Promoción de Salud Nutricional (CPSN)
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Hermosillo、Sonora、墨西哥、83000
- Centro de Salud Urbano Dr. Domingo Olivares
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Hermosillo、Sonora、墨西哥、83000
- Hospital General del Estado de Sonora
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Hermosillo、Sonora、墨西哥、83000
- Hospital Ignacio Chávez
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Hermosillo、Sonora、墨西哥、83180
- Centro Avanzado de Atención a la Salud (CAAPS)
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults (>18 years of age and <65)
- Overweight or Obese (BMI >25 kg/m2 y <50 kg/m2)
- Availability and motivation to attend the intervention program
- Patients who would benefit from participating in the program according to the health providers
- Signing an informed consent
Exclusion Criteria:
- Medical conditions affecting body weight significantly
- Pregnancy or nursing
- Bariatric surgery
- Being unable to participate in regular moderate physical activity
- Blood pressure >160 mm/Hg
- HbA1c>9
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Group Lifestyle Balance Program
Participants will be assigned to an adaptation of the "Group Lifestyle Balance Program", a behavioral curriculum implemented in the Diabetes Prevention Program Study. The Group Lifestyle Balance Program will be provided weekly for the first 3.5 months, bi-weekly from 3.5 to 6 months and then monthly until 12 months. Health care providers will be trained for the implementation of the intervention. Additionally, participants will attend at least one monthly visit with a nutritionist (individually). The lifestyle objectives for participants will be as follows:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in body weight
大体时间:Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in waist circumference
大体时间:Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
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Change in body fat percentage
大体时间:Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
|
Change in the Beck Depression Inventory score
大体时间:Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
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Change in the Short Form-36 Health Survey score
大体时间:Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
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Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
|
Change in the Perceived Stress Scale (PSS) -14 score
大体时间:Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
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Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
|
|
Change in systolic and diastolic blood pressure
大体时间:Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
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Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
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Change in fasting glucose
大体时间:Change in fasting glucose from baseline to 12 months
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Change in fasting glucose from baseline to 12 months
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Change in total cholesterol
大体时间:Change in total colesterol from baseline to 12 months
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Change in total colesterol from baseline to 12 months
|
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Change in LDL-cholesterol
大体时间:Change in LDL-cholesterol from baseline to 12 months
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Change in LDL-cholesterol from baseline to 12 months
|
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Change in HDL-cholesterol
大体时间:Change in HDL-cholesterol from baseline to 12 months
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Change in HDL-cholesterol from baseline to 12 months
|
|
Change in triglycerides
大体时间:Change in triglycerides from baseline to 12 months
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Change in triglycerides from baseline to 12 months
|
|
Change in fasting insulin
大体时间:Change in fasting insulin from baseline to 12 months
|
Change in fasting insulin from baseline to 12 months
|
|
Change in HOMA-IR
大体时间:Change in HOMA-IR from baseline to 12 months
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Change in HOMA-IR from baseline to 12 months
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Change in liver enzymes [AST and ALT]
大体时间:Change in liver enzymes [AST and ALT] from baseline to 12 months
|
Change in liver enzymes [AST and ALT] from baseline to 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Rolando G Díaz, Ph.D.、Universidad de Sonora
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (预期的)
2017年4月1日
研究完成 (预期的)
2017年4月1日
研究注册日期
首次提交
2015年8月25日
首先提交符合 QC 标准的
2015年8月28日
首次发布 (估计)
2015年9月2日
研究记录更新
最后更新发布 (估计)
2016年5月23日
上次提交的符合 QC 标准的更新
2016年5月20日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.