OUTPATIENT

INTRODUCTION

Located at St. Luke's-Roosevelt Hospital, the Outpatient Core for the New York Obesity Research consists of the Weight Control Unit (St. Luke's site) and provides therapy for about 150 obese outpatients per week. Since its inception in 1977, more than 4000 obese patients, representing a broad cross-section of ethnic groups and socio-economic classes, have been treated at the Core's Weight Control Unit and more recently at the Vanltallie Center for Nutrition and Weight Management. The Outpatient Core reflects our strong conviction that no broadly-based approach to the study of human obesity can afford to neglect the clinical investigation of patients in their usual milieu.

The Weight Control Unit is medically-directed outpatient treatment and research programs staffed by trained professionals in medicine, nutrition, psychology, and exercise physiology. From its beginning thirteen years ago, the Core's programs have emphasized:

1. the requirement that all patients have a thorough medical evaluation,
2. that all treatment be medically supervised by physicians knowledgeable about weight loss and its risks and benefits,
3. that patients have the benefit of state-of-the-art treatments, including nutrition counseling, behavior therapy, exercise counseling, medical monitoring, and when appropriate, psychotherapy,
4. an orientation of the treatment program toward the goal of weight maintenance after weight loss,
5. evaluation and testing of new approaches to obesity treatment which integrate current theories in education, psychology, and physiology.
6. Evaluation of new anti-obesity agents through participation in industry-sponsored randomized, controlled, clinical trials.

The Core's Weight Control Unit is located at the St. Luke's site and at present concentrates entirely on research related to outpatient treatment.

DEFINITION AND PURPOSE

Purpose

The specific objectives of the Outpatient Core include:

1. provision of state-of-the-art clinical evaluation and treatment for obese patients;
2. collection of extensive, readily retrievable, descriptive laboratory and clinical data on all of its patients;
3. provision of sites, setting, staff, resources and an administrative framework that favor the conduct of controlled research studies of obese outpatients;
4. provision of an ongoing flow of outpatients who are available to cooperating investigators who require obese human subjects for approved research activities.
5. feedback of new research findings to the treatment of individual patients;
6. training of students, post-graduate research fellows, and visiting physicians.

Techniques and Services Offered

The Core provides services in two interrelated clinical areas, patient care and clinical research.

All patients admitted into the program join with the understanding that the Outpatient Core is part of a research center and they may be involved in one or more research projects. As there are usually many active studies, a diverse range of choices is presented to each patient.

The research-oriented Weight Control Unit provides services related to study design, implementation, subject recruitment, data collection, entry and analysis for proposed and ongoing studies.

Services Offered

There are five categories of service offered:

Study Design: The staff assists individual investigators in developing an experimental plan, selecting measurement techniques, writing the protocol, estimating sample size, preparing the institutional review board application with informed consent, and negotiating with government agencies and legal counsel. Statistical design consultation by Dr. Stanley Heshka and Dr. Harry Kissileff, who are also members of the Biostatistical Core.

Patient Recruitment: Once approval for the study is obtained, the staff develops a recruitment plan. Sources of patients include ongoing referrals, data base of previous study patients, radio and TV announcements, extensive mailings to local physicians and dietitians, and newspaper advertisements. A substantial effort is required by the Unit's staff in entering each subject into one or more of the studies for which they are eligible and wish to participate in.

Data Collection and Entry: Dr. Heshka is available for building study databases. Part-time employees supplement the data collection activities of the full-time staff. Hard copies of each patient record are prepared and filed. Selective study data is then entered, if appropriate, into one of the Unit's computers.

Data Analysis: Investigators can analyze data entered into the Core's computers with the assistance of Weight Control Unit and Biostatistical Core staff. A library of statistical programs is maintained on core computers and user accounts are also maintained on the Columbia University mainframes. The Core provides access to many full-featured statistical packages and techniques using SAS, SPSS, S-Plus, IMSL and many more specialized programs (e.g., LISREL, HLM, etc.). Investigators also have the option of communicating through the Internet by ftp or e-mail.

Manuscript Preparation: In addition to data analysis, the Weight Control Unit's research staff can assist in preparing manuscripts for publication. Graphics capabilities, slide preparation, and similar types of assistance are also available.