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The Healthy Life Choices Project in HIV-Positive Patients

NCT00017810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-08-17

No results posted yet for this study

Summary

This randomized clinical trial is designed to determine the efficacy of a dietary intervention to reduce the frequency of bowel movements and improve stool consistency as compared with subjects assigned to a control group. The study enrolled HIV patients with a history of three or more episodes of diarrhea for 3 weeks or more.

The purpose of this study was to compare the efficacy of a combined behavioral dietary intervention using normal foods (Condition 1: treatment) with HIV self-care (Condition 2: control) to reduce the frequency and improve the consistency of bowel movements after 3 weeks and 24 weeks of study intervention.

Conditions

Interventions

BEHAVIORAL

Dietary intervention

The dietary intervention focused on diarrhea management using skill-building techniques that provided subjects with knowledge and a sense of confidence about making food choices. Behavioral dietary intervention (Condition 1: treatment) - a low-fat, lactose-free, low insoluble fiber, high soluble fiber, and caffeine-free diet based on normal foods

BEHAVIORAL

HIV Self-Care

Standard information regarding self-care and healthy living with HIV - focused on healthy living with HIV and did not include dietary restrictions or dietary information that could affect bowel movements.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Joyce Anastasi, PhD · Helen F. Pettit Endowed Professor of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-09-30
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00017810 on ClinicalTrials.gov