Clinical trial NCT00017810: The Healthy Life Choices Project in HIV-Positive Patients
Official title: Symptom Management of HIV-related Diarrhea by Using Normal Foods: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
HIV Infections
Keywords: complementary therapies
Behavior Therapy
Diarrhea
Diet Therapy
Food
HIV Seropositivity
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2001-06-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univ School of Nursing / Center for AIDS Research
state: New York
Study officials:
affiliation: Helen F. Pettit Endowed Professor of Nursing
name: Joyce Anastasi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.