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

This study is designed to be an interventional, prospective, randomized, case-control clinical trial. Procedures will be done in Starzl Transplant Institute and Center for Liver disease, Kaufmann building, UPMC.

Subjects selected to participate in this study, are adult liver transplant recipients who had undergone one liver transplantation during 6 months before the time of inclusion. They must be able to communicate in English (to be able to independently follow directives and record their activities in recall diaries). Patients will be excluded from the study if they are under 18 years old, refuse to give a written consent to participate in the study, have received liver graft more than 6 months before time of inclusion, have psychological or nervous disorders, have cardiovascular or musculoskeletal health problems interfering with basic physical activity, or have any manifestation 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).

Verifying the eligibility of patients for participation in the study will be done through reviewing data in medical history, physical examination and investigations included in the patients' medical records. Complete blood count, liver function tests, fasting glucose and lipid profile, imaging and histopathologic investigations, abdominal imaging, pathology reports of liver biopsy, stress ECG, echocardiography. These tests are performed for standard of care.

Subjects will be randomly grouped into groups by simple randomization method. One of the investigators will randomly pick one folded paper out of a plastic bag that contains folded papers labeled on the folded side with the number of the group.

The first group (Group 1) will include the control subjects. They will receive one session of dietary and behavioral education. The second group (Group 2) will be the interventional group. They will receive a weight management and life style modification program similar to what has been previously described (Kelley et al. 2004). The program will be presented by a registered dietitian at UPMC". 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. The dietitian will provide each subject with diary for daily recording of dietary intake and physical activity respectively. Following the initial 6-week program patients will attend follow up session every 6 months for 5 years for dietary and behavioral education and to check dietary and physical activity diaries, reinforce and encourage compliance with dietary and physical exercise recommendations, answer questions and address problems. Patients will be required to attend at least 60% of the follow up sessions on site with face to face education. Attempts will be made to schedule these sessions on the same day of their regular clinical follow up to facilitate compliance. Up to 40% of monthly follow up sessions may be provided on the phone for patients who cannot attend on site because of travel restraints. The dietitian will call the candidate within few days after the missing appointment to check and encourage compliance, check for changes in weight. Each session will be held for up to 1 hour at the health education room of center for liver diseases. All sessions will be with a registered dietitian.