Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Impact of Weight loss on GERD symptoms
研究概览
简要总结
By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric contents. The investigators hypothesized that the loss of weight will decrease this gradient and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects health related quality of life. Since loss of weight may decrease gastroesophageal reflux, the investigators hypothesized that it obesity contributes to poor quality of life in GERD subjects and losing weight should also favorably impact and improve quality of life in GERD patients.
详细描述
The current proposal is a prospective, observational cohort study This study aims to determine the impact of structured weight loss (MOVE program) on GERD symptoms in overweight and obese veterans enrolled in a MOVE program. Successful weight loss will be defined as loss of 10% or higher baseline weight at 6 months follow up. Cases will be defined as subjects who achieved successful weight loss and controls as those who did not. GERD symptoms in subjects who lose weight (cases) will be compared to those with no weight loss (controls). Validated GERQ, RDQ and QOLRAD questionnaires will be used to assess prevalence of GERD symptoms, QOL and impact of weight loss on these symptoms. All MOVE participants will complete a validated GERQ, RDQ and QOLRAD questionnaires at baseline MOVE clinic visit and RDQ and QOLRAD during their follow up visits. Patient's total RDQ scores at baseline and follow up visits will be used to determine change in frequency and severity of GERD symptoms with weight loss, similarly change in the total QOLRAD questionnaire scores from baseline will be used to assess change in HRQOL with weight loss. Apart from information provided in MOVE!23, GERQ, RDQ and QOLRAD questionnaires, relevant information pertaining to obesity and GERD association will be obtained from patient's computerized medical records.
The impact of weight loss on GERD symptoms will be assessed. The impact of weight loss on QOL and GERD medication usage among MOVE participants will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a Kansas City Veterans Hospital patient who is enrolled in the MOVE weight loss program
- •Patients with a BMI > 25 with associated co-morbid medical conditions such as diabetes, high blood pressure, high cholesterol, arthritis, heart disease, low back pain, sleep apnea, or other obesity associated condition.
- •Enrollment in MOVE program is optional for patients with a BMI > 25 with no co-morbid medical conditions.
- •Enrollment for patients 70 years or older with BMI > 25 is optional and requires mandatory medical clearance prior to beginning new physical activity and closer nutritional supervision to minimize protein, vitamin and mineral deficiencies.
排除标准
- •Active cancer other than non-melanoma skin cancer
- •End stage COPD, congestive heart failure
- •End stage neurologic disorder (Parkinson's, ALS, MS)
- •Long-term care facility resident
- •End stage renal disease
- •Moderate to severe cognitive impairment (dementia, post-stroke)
- •Active psychosis or substance abuse
- •AIDS (except asymptomatic HIV infection)
研究组 & 干预措施
Obese individuals with weight loss
Self support, group sessions
干预措施: Self support, group sessions (Behavioral)
Obese individuals without weight loss
self support, group sessions
干预措施: Self support, group sessions (Behavioral)
结局指标
主要结局
Impact of Weight loss on GERD symptoms
时间窗: 48 months
次要结局
- Impact of weight loss on quality of life and GERD symptoms(48 months)
研究者
PRATEEK SHARMA
Principal Investigator
Midwest Biomedical Research Foundation