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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Midwest Biomedical Research Foundation
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT01574573
First received: April 6, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
GERD
Obesity
Behavioral: Self support, group sessions
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Impact of Weight loss on GERD symptoms [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of weight loss on quality of life and GERD symptoms [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese individuals with weight loss
Self support, group sessions
Behavioral: Self support, group sessions
Self support,group sessions
Experimental: Obese individuals without weight loss
self support, group sessions
Behavioral: Self support, group sessions
Self support,group sessions

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574573

Contacts
Contact: April Higbee, RN,BSN 816-861-4700 ext 57456 april.higbee@va.gov

Locations
United States, Kansas
Topeka VA Medical Center Recruiting
Topeka, Kansas, United States, 66622
Contact: David Scharpenburg, RD    785-350-3111      
Principal Investigator: David Scharpenburg, RD         
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN,BSN    816-861-4700    april.higbee@va.gov   
Principal Investigator: Prateek Sharma, MD         
Sub-Investigator: Amit Rastogi, MD         
Sub-Investigator: Mandeep Singh, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Kansas City VA Medical Center
  More Information

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT01574573     History of Changes
Other Study ID Numbers: PS0054
Study First Received: April 6, 2012
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Midwest Biomedical Research Foundation:
Obesity
GERD
Weight loss

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Gastroesophageal Reflux
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 29, 2014