NCT01574573

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

7.9 years

First QC Date

April 6, 2012

Last Update Submit

January 16, 2018

Conditions

GERDObesity

Keywords

ObesityGERDWeight loss

Outcome Measures

Primary Outcomes (1)

  • Impact of Weight loss on GERD symptoms

    48 months

Secondary Outcomes (1)

  • Impact of weight loss on quality of life and GERD symptoms

    48 months

Study Arms (2)

Obese individuals with weight loss

EXPERIMENTAL

Self support, group sessions

Behavioral: Self support, group sessions

Obese individuals without weight loss

EXPERIMENTAL

self support, group sessions

Behavioral: Self support, group sessions

Interventions

Self support, group sessionsBEHAVIORAL

Self support,group sessions

Obese individuals with weight lossObese individuals without weight loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Topeka VA Medical Center

Topeka, Kansas, 66622, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (12)

  • 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.

    PMID: 15831922BACKGROUND

  • 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.

    PMID: 15246126BACKGROUND

  • 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.

    PMID: 8707073BACKGROUND

  • 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.

    PMID: 11467624BACKGROUND

  • 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.

    PMID: 14535869BACKGROUND

  • 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.

    PMID: 9136821BACKGROUND

  • 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.

    PMID: 984016BACKGROUND

  • 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.

    PMID: 16181362BACKGROUND

  • 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.

    PMID: 17142109BACKGROUND

  • 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.

    PMID: 10573376BACKGROUND

  • Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

    PMID: 16595758BACKGROUND

  • Murray L, Johnston B, Lane A, Harvey I, Donovan J, Nair P, Harvey R. Relationship between body mass and gastro-oesophageal reflux symptoms: The Bristol Helicobacter Project. Int J Epidemiol. 2003 Aug;32(4):645-50. doi: 10.1093/ije/dyg108.

    PMID: 12913045BACKGROUND

MeSH Terms

Conditions

Gastroesophageal RefluxObesityWeight Loss

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Prateek Sharma, MD

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2012

First Posted

April 10, 2012

Study Start

June 1, 2009

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(2)