Back to resultsThe Healthy Life Choices Project in HIV-Positive Patients
Primary Purpose
Diarrhea, HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dietary intervention
HIV Self-Care
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring complementary therapies, Behavior Therapy, Diarrhea, Diet Therapy, Food, HIV Seropositivity
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
Sites / Locations
- Columbia Univ School of Nursing / Center for AIDS Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Condition 1: Dietary Intervention
Condition 2 (Control): HIV Self-Care
Arm Description
Patients will receive behavioral dietary intervention using normal foods.
Patients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study).
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00017810
First Posted
June 13, 2001
Last Updated
August 13, 2021
Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00017810
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, HIV Infections
Keywords
complementary therapies, Behavior Therapy, Diarrhea, Diet Therapy, Food, HIV Seropositivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Condition 1: Dietary Intervention
Arm Type
Experimental
Arm Description
Patients will receive behavioral dietary intervention using normal foods.
Arm Title
Condition 2 (Control): HIV Self-Care
Arm Type
Active Comparator
Arm Description
Patients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study).
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
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
Intervention Name(s)
HIV Self-Care
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Anastasi, PhD
Organizational Affiliation
Helen F. Pettit Endowed Professor of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univ School of Nursing / Center for AIDS Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16800167
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.
Results Reference
result
Learn more about this trial
The Healthy Life Choices Project in HIV-Positive Patients
We'll reach out to this number within 24 hrs