Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study



Status:Terminated
Conditions:Gastroesophageal Reflux Disease , Obesity Weight Loss
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/19/2018
Start Date:June 2009
End Date:May 2017

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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.

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.

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)
We found this trial at
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Kansas City, Missouri 64128
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Kansas City, MO
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Topeka, Kansas 66622
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Topeka, KS
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