Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2009 by University of Pittsburgh
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00878592
First received: April 8, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

This study is to assess value of providing classes about dietary and life style modifications to decrease or prevent weight gain, less occurrence or better control of weight gain associated disorders such as high blood sugar, hypertension, heart or brain vessels problems.Candidates for this study will be those who have got liver transplant within 6 months of their post transplant period.


Condition Intervention Phase
Post Liver Transplantation Weight Gain
Post Liver Transplantation Obesity
Nonalcoholic Steatohepatitis
Behavioral: Dietary and life style modification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • waist circumference [ Time Frame: before starting intervention, then every 6 months, afterwards for up to 5 years ] [ Designated as safety issue: No ]
  • weight, height (for BMI calculation) [ Time Frame: before starting intervention, then every 6 months, afterwards for up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • skin fold thickness [ Time Frame: before starting intervention, then every 6 months, afterwards for up to 5 years ] [ Designated as safety issue: No ]
  • survival rate [ Time Frame: anually for up to 5 years ] [ Designated as safety issue: No ]
  • Co morbidity events [ Time Frame: anually for up to 5 years ] [ Designated as safety issue: No ]
  • histological scores of necro-inflammation (Ishak score) and steatosis (Dixon's scale) of the implanted liver. [ Time Frame: at 1 year from start of inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: October 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
The first group (Group 1) will include the control subjects. They will receive one session of dietary and behavioral education.
Experimental: Dietary and Lifestyle counseling
This group will receive a weight management and life style modification program. It consists of up to 6 weekly sessions of nutritional and physical exercise education. These initial sessions will concentrate on lifestyle modifications program including healthy food selections, emphasizing reduced fat consumption (<=30% of daily calories) and restriction of proteins to create a daily negative energy balance of ~500 kcal/day. Participants will be encouraged to start with 10 minutes of outdoor or at home physical activity such as walking or cycling then gradually increase the activity duration up to 30 minutes daily.
Behavioral: Dietary and life style modification
This group will receive a weight management and life style modification program. It consists of up to 6 weekly sessions of nutritional and physical exercise education. These initial sessions will concentrate on lifestyle modifications program including healthy food selections, emphasizing reduced fat consumption (<=30% of daily calories) and restriction of proteins to create a daily negative energy balance of ~500 kcal/day. Participants will be encouraged to start with 10 minutes of outdoor or at home physical activity such as walking or cycling then gradually increase the activity duration up to 30 minutes daily.
Other Names:
  • obesity reducing regimens
  • besity management programs
  • weight reduction program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult liver transplant recipients
  • Those who have undergone one liver transplantation during 3 months before the time of inclusion.
  • Ability to communicate in English (to be able to independently follow directives and record their activities in recall diaries).

Exclusion Criteria:

  • Patients under 18 years old
  • refusal to give a written consent to participate in the study
  • Those who received liver graft more than 3 months before time of inclusion
  • Significant cardiovascular or musculoskeletal health problems interfering with basic physical activity
  • Any manifestations of hepatic failure such as ascites and hepatic encephalopathy
  • Patients will be removed from the study if they develop intolerance to the dietary and physical recommendations (e.g. remarkable fatigue).
  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: NCT00878592

Contacts
Contact: Hossam M Kandil, M.D, Ph.D 412-647-1170 hmk2@pitt.edu

Locations
United States, Pennsylvania
Center for Liver Diseases, UPMC. Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Hossam M Kandil, M.D, Ph.D    412-647-9268    hmk2@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Hossam M Kandil, MD, PhD assistant professor of medicine
  More Information

No publications provided

Responsible Party: Hossam M Kandil, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00878592     History of Changes
Other Study ID Numbers: PRO08010154, non applicable
Study First Received: April 8, 2009
Last Updated: April 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Post liver transplant
weight reduction classes
obesity
weight management
dietary and lifestyle modification

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on October 19, 2014