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Study Profile:
Nutrition for Healthy Living (NFHL)

Revised:

October 12, 2006

Study Site:

Tufts University School of Medicine

Study Name:

Nutrition for Healthy Living (NFHL)

Study Status:

Data analysis only

Principal Investigator:

Sherwood Gorbach, MD

Years of Funding:

Study Design:

 

Study Aims:

  1. NFHL Cohort was created in 1995 to assess the nutritional consequences of HIV infection and to determine how malnutrition adversely affects the course of the disease. The main focus of the project was on wasting.
  2. Project 1, funded from 2000-2005, aims to determine whether nutrition is a predictor of clinical outcome, independently of virologic or treatment status, and to define the effects of HAART on nutritional status.

Study or Clinic Location

Tufts University School of Medicine/Tufts Medical Center General Clinical Research Center (GCRC)

# of Participants:

Goal:

425

Actual Participants:

Inclusion Criteria:

  1. HIV+ and at least 18 years of age
  2. Motivated to participate in a longitudinal study for at least 5 years
  3. Signs consent
  4. Has health care provider or clinic for HIV care
  5. Speaks English adequately to participate in a telephone interview without assistance
  6. Has access to a telephone for monthly telephone interview
  7. Women are not pregnant at entry to study

Exclusion Criteria:

  1. Active opportunistic infection or malignancy (except cervical cancer, kaposi’s sarcoma, nonmelanoma skin cancer)
  2. Daily fevers >100.3° fahrenheit
  3. Renal failure requiring dialysis
  4. Hormonal/Surgical sex change in the process or in the past
  5. Weight > 300 pounds

Definition of Drug Use

  1. Active (used within the past 6 months) IVDU
  2. Active (used within the past 6 months) non-injection drug use, including heroin that was smoked or snorted, crack, cocaine, poppers, and unprescribed drugs including sedatives, methadone, codeine, Demerol, morphine, barbiturates, downers)

Participant Characteristics:

% Female:

% HIV+

% DU (IDU or non-IDU)

% IVDU

Total:        % Male        % Female

% non-IVDU

Total:        % Male        % Female

Study Domains:

(At Entry and)

Every 6 Months

Every 12 Months

 

Anthropometrics/Body Composition:

 

Height, weight, skinfolds

X

 

 

Waist/Hip Circumference

X

 

 

Bioelectrical Impedence (BIA)

X

 

 

Handgrip Strength

X

 

 

Dual Energy X-Ray Absorptiometry (DEXA)

X

 

Blood Pressure

X

 

EKG

 

X**

 

Chair Stand

 

X

 

Dietary Intake:

 

3-day food record or 2, 24-hour recalls

X

 

 

Clinical Status Questionnaire:
Socio-demographic information
Medical history, medications
Quality of life, depression
Recreational Drug Use

X

 

 

Energy Expenditure

 

Physical Activity Questionnaire

X

 

 

Indirect Calorimetry (REE)

X

 

 

Weight & Health Diary X (to be completed once each week throughout the study)

X

 

 

Gastrointestinal Function:

 

D-xylose absorption test

 

X

 

Stool specimen for fat absorption

 

X***

 

Laboratory Tests:

 

Viral Load

X

 

 

CBC, differential, platelets

X

 

 

T-cell subsets

X

 

 

Chemistry:

X

 

 

Micronutrients (Zn, Sel, A,E)

X

 

 

Lipids

X

 

 

Glycoslylated Hemoglobin

X

 

 

Fasting glucose/insulin

X

 

 

Hemoglobin A1c

X

 

 

Serum testosterone (Baseline only)

 

 

 

** at baseline, then once/2 years
*** at baseline, then once/3 years

Data collection instruments:

  • Screening Questionnaire
  • Clinical Status Questionnaire
  • 3-day Food Record Booklets, or 24-hour recall forms
  • Weight & Health Diary
  • Quality of Life Questionnaire
  • Body Shape Change Questionnaire

 

 

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