HIV InfectionsTACH001NCT00549367
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
A study testing Nutrition Counselling in people with HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nutrition Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2007to Feb 2023
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- 18 years of age or older
- Receiving ongoing care as part of the TRCARC Family Clinic (TRCARC Wellness Plus clinic)
- Either ART naive or have been on stable ART for more than 6 months
Who cannot join
- HIV negative
- Unintentional weight loss of more than 10% usual body weight, or BMI<17
- BMI>30
- Suspected or documented HIV related opportunistic infection
- Pregnant women
- Women less than 3 months post-partum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)
To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand.
Read the detailed description
To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand. This will be achieved by determining if dietary counselling and nutrition education has an effect on nutritional status (weight, lean body mass and fat mass), dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction
- Conditions
- HIV Infections
- Being tested
- Nutrition Counselling
- Keywords
- Nutritional status, Nutrition counselling, Nutrition assessment, HIV, Alternative Medicine, Complementary Medicine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition CounsellingBehavioural
Clients will receive ongoing nutrition assessment and dietary counselling. The intervention arm will receive all baseline assessments and individual nutritional assessment, counselling and nutrition management plans using standards of practice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Clients in the control arm of the study will receive nutrition assessment only for the first 24 weeks and the be transferred to nutrition counselling group Receives: Behavioral: Nutrition Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition measured by BIA and anthropometry
Measured: 48 weeks
Secondary outcomes (1)
Change in dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2022
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor
- Investigators
- Simon J Sadler, Principal investigator, Albion Street Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549367
- Sponsor's protocol ID
- TACHIN001
- Acronym
- TACH001
- Status last verified
- Jul 2021
- First submitted
- 23 Oct 2007
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)
- ClinicalTrials.gov ID
- NCT00549367
- Acronym / sponsor ID
- TACH001 / TACHIN001
- Conditions
- HIV Infections
- Keywords
- Nutritional status, Nutrition counselling, Nutrition assessment, HIV, Alternative Medicine, Complementary Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Nov 2007 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 25 Oct 2007 (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.
To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand.
Detailed description
To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand. This will be achieved by determining if dietary counselling and nutrition education has an effect on nutritional status (weight, lean body mass and fat mass), dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Nutrition CounsellingClients in the control arm of the study will receive nutrition assessment only for the first 24 weeks and the be transferred to nutrition counselling group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive
- 18 years of age or older
- Receiving ongoing care as part of the TRCARC Family Clinic (TRCARC Wellness Plus clinic)
- Either ART naive or have been on stable ART for more than 6 months
Key exclusion criteria (6 listed)
- HIV negative
- Unintentional weight loss of more than 10% usual body weight, or BMI<17
- BMI>30
- Suspected or documented HIV related opportunistic infection
- Pregnant women
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 |
|---|---|---|
| Nutrition CounsellingClients will receive ongoing nutrition assessment and dietary counselling. The intervention arm will receive all baseline assessments and individual nutritional assessment, counselling and nutrition management plans using standards of practice | Behavioural | 1 |
Primary outcome
body composition measured by BIA and anthropometry
Time frame: 48 weeks
1 secondary outcome
Change in dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction
Time frame: 48 weeks
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 Feb 2023.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Simon J Sadler principal investigator
Albion Street Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Counselling in people with HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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 4 inclusion and 6 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 Feb 2023. 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 Thailand. 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.
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.
What does the primary outcome measure?
body composition measured by BIA and anthropometry (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2023.