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

January 16, 2018 updated by: PRATEEK SHARMA, Midwest Biomedical Research Foundation
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Topeka, Kansas, United States, 66622
        • Topeka VA Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of Weight loss on GERD symptoms
Time Frame: 48 months
48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of weight loss on quality of life and GERD symptoms
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Kansas City Veteran Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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