Clinical trial NCT01574573: Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
Official title: Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GERD
Obesity
Keywords: Obesity
GERD
Weight loss
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Veteran Affairs Medical Center
First posted: 2012-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Impact of Weight loss on GERD symptoms
timeFrame: 48 months
Secondary outcomes:
measure: Impact of weight loss on quality of life and GERD symptoms
timeFrame: 48 months
Other outcomes:
Locations:
city: Topeka
country: United States
facility: Topeka VA Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
Study officials:
affiliation: Kansas City VA Medical Center
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
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