The Healthy Life Choices Project in HIV-Positive Patients

Symptom Management of HIV-related Diarrhea by Using Normal Foods: A Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Diarrhea
• Intervention / Treatment: Behavioral: Dietary intervention; Behavioral: HIV Self-Care

Detailed Description

Thirty to fifty percent of individuals with HIV can be expected to have diarrhea at some point during their illness. Diarrhea can be a chronic condition in HIV disease wherein three or more daily episodes of loose, watery stools are experienced for 4 weeks or more. Chronic diarrhea has been associated with significant morbidity, weight loss, and severe malnutrition. Researchers have reported that patients with chronic diarrhea experience a marked decrease in quality of life in comparison with HIV patients without diarrhea.

The goal of nutrition management for patients with chronic diarrhea is to ensure that adequate caloric consumption meets the metabolic needs of such individuals and to provide symptomatic relief. HIV infection, regardless of stage, causes an increase in resting energy expenditure because of the response of the body to the viral infection. Proper nutrition management can therefore assist in preventing further nutritional imbalances.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia Univ School of Nursing / Center for AIDS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• diagnosed with HIV or AIDS based on the Centers for Disease Control and Prevention criteria
• experienced a minimum of three episodes of loose, watery, or liquid stools in a 24-hour period for at least 3 weeks
• provide verification from their primary care provider of HIV status, chronic diarrhea history, documentation of medical evaluations completed
• laboratory confirmation that stool samples were negative for pathogens
• patients who were taking antidiarrheal agents were required to be on a stable regimen (same drug, dosage, and frequency) for at least 7 days before entry into the study and still meet diarrhea frequency and consistency criteria
• antiretroviral agents taken to manage HIV required a stable regimen (same drugs, dosage, and frequency) for at least 8 weeks before study entry
• patients were required to complete a mini-mental state examination, obtaining a score of 24 or higher

Exclusion Criteria:

• not meeting any of the above criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1: Dietary Intervention; Patients will receive behavioral dietary intervention using normal foods.	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
Active Comparator: Condition 2 (Control): HIV Self-Care; Patients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study).	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.

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Joyce Anastasi, PhD, Helen F. Pettit Endowed Professor of Nursing

Publications and helpful links

General Publications

• Anastasi JK, Capili B, Kim AG, McMahon D, Heitkemper MM. Symptom management of HIV-related diarrhea by using normal foods: A randomized controlled clinical trial. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):47-57. doi: 10.1016/j.jana.2006.01.005.

Study record dates

Study Major Dates

• Study Start: September 1, 1996
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: June 13, 2001
• First Submitted That Met QC Criteria: June 13, 2001
• First Posted (Estimate): June 14, 2001

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Diarrhea; complementary therapies; HIV Seropositivity; Behavior Therapy; Food; Diet Therapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 6510; R29NR004169 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED