Impact of Physician-supervised Nonsurgical Weight Management Program on Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 主要终点
- Prevalence of metabolic syndrome at week 13
研究概览
简要总结
The aim of this study was to assess the impact of a physician-supervised non-surgical medical weight management program on prevalence of metabolic syndrome and to examine the relationship between program retention and levels of key indicators of metabolic syndrome among participants that self-enrolled to the program. A total of 479 overweight or obese participants aged 19 years or older were observed. The revised National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria were used to define metabolic syndrome.
详细描述
Each individual self-enrolled to a physician-supervised non-surgical weight management program, hereafter referred to as the Program. They received a weight loss intervention as a part of routine medical care in the Program. At the end of their first consultation, each individual that met the inclusion criteria and failed to meet the exclusion criteria was asked if he or she would like to join the study. Each individual was informed that the study would not change the type or level of care that he or she would receive while enrolled to the program; however, researchers would be studying the effects of their care through additional screenings. Individuals who thereafter signed an informed consent form were monitored for changes in health outcomes without change to the Program.
This study was observational. Health outcomes were assessed in individuals that predefined their program status (i.e., enrolled or not enrolled). Each participant received routine medical care, and the investigators studied the effects of the intervention. No new intervention or intervention specific to participants only was assigned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is at least 18 years of age.
- •The patient is overweight or obese (BMI≥25 kg/m2).
排除标准
- •The patient was previously enrolled in the Medi-Weightloss program
结局指标
主要结局
Prevalence of metabolic syndrome at week 13
时间窗: 13 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 13
Prevalence of metabolic syndrome at week 39
时间窗: 39 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 39
Prevalence of metabolic syndrome at week 52
时间窗: 52 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 52
Prevalence of metabolic syndrome at week 26
时间窗: 26 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 26
次要结局
- Components of metabolic syndrome at week 13 - change in waist circumference (cm)(13 weeks from first visit)
- Components of metabolic syndrome at week 52 - change in blood plasma glucose (mmol/L)(52 weeks from first visit)
- Components of metabolic syndrome at week 39 - change in waist circumference (cm)(39 weeks from first visit)
- Components of metabolic syndrome at week 39 - change in blood pressure (mmHg)(39 weeks from first visit)
- Components of metabolic syndrome at week 39 - change in triglycerides (mmol/L)(39 weeks from first visit)
- Components of metabolic syndrome at week 52 - change in triglycerides (mmol/L)(52 weeks from first visit)
- Components of metabolic syndrome at week 26 - change in blood plasma glucose (mmol/L)(26 weeks from first visit)
- Components of metabolic syndrome at week 13 - change in blood pressure (mmHg)(13 weeks from first visit)
- Components of metabolic syndrome at week 26 - change in triglycerides (mmol/L)(26 weeks from first visit)
- Components of metabolic syndrome at week 13 - change in blood plasma glucose (mmol/L)(13 weeks from first visit)
- Components of metabolic syndrome at week 39 - change in blood plasma glucose (mmol/L)(39 weeks from first visit)
- Components of metabolic syndrome at week 26 - change in high density lipoproteins (HDL, mmol/L)(26 weeks from first visit)
- Components of metabolic syndrome at week 39 - change in high density lipoproteins (HDL, mmol/L).(39 weeks from first visit)
- Components of metabolic syndrome at week 26 - change in waist circumference (cm)(26 weeks from first visit)
- Components of metabolic syndrome at week 52 - change in waist circumference (cm)(52 weeks from first visit)
- Components of metabolic syndrome at week 26 - change in blood pressure (mmHg)(26 weeks from first visit)
- Components of metabolic syndrome at week 52 - change in blood pressure (mmHg)(52 weeks from first visit)
- Components of metabolic syndrome at week 13 - change in triglycerides (mmol/L)(13 weeks from first visit)
- Components of metabolic syndrome at week 13 - change in high density lipoproteins (HDL, mmol/L)(13 weeks from first visit)
- Components of metabolic syndrome at week 52 - change in high density lipoproteins (HDL, mmol/L).(52 weeks from first visit)
研究者
Macklin E. Guzmán
Chief Science Officer
Medi-Weightloss Franchising USA, LLC