The Healthy Life Choices Project in HIV-Positive Patients

NCT ID: NCT00017810

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-09-30
• Study Completion Date: 2003-03-31

Brief 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.

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.

Conditions

Diarrhea; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Condition 1: Dietary Intervention

Patients will receive behavioral dietary intervention using normal foods.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: BEHAVIORAL

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

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).

Group Type: ACTIVE_COMPARATOR

HIV Self-Care

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce Anastasi, PhD

Role: PRINCIPAL_INVESTIGATOR

Helen F. Pettit Endowed Professor of Nursing

Locations

Columbia Univ School of Nursing / Center for AIDS Research

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16800167 (View on PubMed)

Other Identifiers

R29NR004169

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6510

Identifier Type: -

Identifier Source: org_study_id