Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
Primary Purpose
GERD, Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self support, group sessions
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring Obesity, GERD, Weight loss
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)
Sites / Locations
- Topeka VA Medical Center
- Kansas City VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Obese individuals with weight loss
Obese individuals without weight loss
Arm Description
Self support, group sessions
self support, group sessions
Outcomes
Primary Outcome Measures
Impact of Weight loss on GERD symptoms
Secondary Outcome Measures
Impact of weight loss on quality of life and GERD symptoms
Full Information
NCT ID
NCT01574573
First Posted
April 6, 2012
Last Updated
January 16, 2018
Sponsor
Midwest Biomedical Research Foundation
Collaborators
Kansas City Veteran Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01574573
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Closed due to lack of recruitment
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Biomedical Research Foundation
Collaborators
Kansas City Veteran Affairs Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Obesity
Keywords
Obesity, GERD, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese individuals with weight loss
Arm Type
Experimental
Arm Description
Self support, group sessions
Arm Title
Obese individuals without weight loss
Arm Type
Experimental
Arm Description
self support, group sessions
Intervention Type
Behavioral
Intervention Name(s)
Self support, group sessions
Intervention Description
Self support,group sessions
Primary Outcome Measure Information:
Title
Impact of Weight loss on GERD symptoms
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Impact of weight loss on quality of life and GERD symptoms
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prateek Sharma, MD
Organizational Affiliation
Kansas City VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Topeka VA Medical Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66622
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15831922
Citation
Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710-7. doi: 10.1136/gut.2004.051821.
Results Reference
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PubMed Identifier
15246126
Citation
Kulig M, Nocon M, Vieth M, Leodolter A, Jaspersen D, Labenz J, Meyer-Sabellek W, Stolte M, Lind T, Malfertheiner P, Willich SN. Risk factors of gastroesophageal reflux disease: methodology and first epidemiological results of the ProGERD study. J Clin Epidemiol. 2004 Jun;57(6):580-9. doi: 10.1016/j.jclinepi.2003.10.010.
Results Reference
background
PubMed Identifier
8707073
Citation
McDougall NI, Johnston BT, Kee F, Collins JS, McFarland RJ, Love AH. Natural history of reflux oesophagitis: a 10 year follow up of its effect on patient symptomatology and quality of life. Gut. 1996 Apr;38(4):481-6. doi: 10.1136/gut.38.4.481.
Results Reference
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PubMed Identifier
11467624
Citation
Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am J Gastroenterol. 2001 Jul;96(7):1998-2004. doi: 10.1111/j.1572-0241.2001.03932.x.
Results Reference
background
PubMed Identifier
14535869
Citation
Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, Lind T, Meyer-Sabellek W, Malfertheiner P, Stolte M, Willich SN. Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease-- an analysis based on the ProGERD initiative. Aliment Pharmacol Ther. 2003 Oct 15;18(8):767-76. doi: 10.1046/j.1365-2036.2003.01770.x.
Results Reference
background
PubMed Identifier
9136821
Citation
Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
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PubMed Identifier
984016
Citation
Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
Results Reference
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PubMed Identifier
16181362
Citation
El-Serag HB, Kvapil P, Hacken-Bitar J, Kramer JR. Abdominal obesity and the risk of Barrett's esophagus. Am J Gastroenterol. 2005 Oct;100(10):2151-6. doi: 10.1111/j.1572-0241.2005.00251.x.
Results Reference
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PubMed Identifier
17142109
Citation
El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol. 2007 Jan;5(1):17-26. doi: 10.1016/j.cgh.2006.09.016. Epub 2006 Dec 4.
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PubMed Identifier
10573376
Citation
Fisher BL, Pennathur A, Mutnick JL, Little AG. Obesity correlates with gastroesophageal reflux. Dig Dis Sci. 1999 Nov;44(11):2290-4. doi: 10.1023/a:1026617106755.
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Citation
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Citation
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Results Reference
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Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
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