DiarrheaPhase 2NCT00017810
The Healthy Life Choices Project in HIV-Positive Patients
A Phase 2 study testing Dietary intervention and HIV Self-Care in people with Diarrhea and HIV Infections, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, HIV Infections
- What is being tested?
- Dietary intervention and HIV Self-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Mar 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not meeting any of the above criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Univ School of Nursing / Center for AIDS Research
New York, New York, 10032
About this study
Official title: 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.
Read the 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
- Being tested
- Dietary intervention, HIV Self-Care
- Keywords
- complementary therapies, Behavior Therapy, Diarrhea, Diet Therapy, Food, HIV Seropositivity
- Medical subject headings
- Diarrhea, HIV Infections, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
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
HIV Self-CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Dietary Intervention | Experimental | Patients will receive behavioral dietary intervention using normal foods. Receives: Behavioral: Dietary intervention |
| Condition 2 (Control): HIV Self-Care | Active comparator | Patients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study). Receives: Behavioral: HIV Self-Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2001 (estimated)
- Study startSep 1996
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Joyce Anastasi, PhD, Principal investigator, Helen F. Pettit Endowed Professor of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017810
- Sponsor's protocol ID
- 6510
- Other IDs
- R29NR004169
- Status last verified
- Aug 2021
- First submitted
- 13 Jun 2001
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 16800167
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management of HIV-related Diarrhea by Using Normal Foods: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00017810
- Acronym / sponsor ID
- 6510
- Conditions
- Diarrhea, HIV Infections
- Keywords
- complementary therapies, Behavior Therapy, Diarrhea, Diet Therapy, Food, HIV Seropositivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 1996
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 14 Jun 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Dietary Intervention | Experimental | Behavioral: Dietary interventionPatients will receive behavioral dietary intervention using normal foods. |
| Condition 2 (Control): HIV Self-Care | Active comparator | Behavioral: HIV Self-CarePatients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- not meeting any of the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionThe 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 | Behavioural | Condition 1: Dietary Intervention |
| HIV Self-CareStandard 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. | Behavioural | Condition 2 (Control): HIV Self-Care |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Results publication: PubMed 16800167Anastasi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Diarrhea
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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Lactic Acid Bacteria in Functional Diarrheal Disorders
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Immune-related Adverse Event, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Anastasi, PhD principal investigator
Helen F. Pettit Endowed Professor of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dietary intervention and HIV Self-Care in people with Diarrhea and HIV Infections, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.