The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Thai Red Cross AIDS Research Centre
Sponsor:
Thai Red Cross AIDS Research Centre
Collaborators:
Albion Street Centre
Mahidol University
Information provided by:
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT00549367
First received: October 23, 2007
Last updated: April 21, 2016
Last verified: April 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Nutrition Counselling |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001) |
Resource links provided by NLM:
Further study details as provided by Thai Red Cross AIDS Research Centre:
Primary Outcome Measures:
- body composition measured by BIA and anthropometry [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 153 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
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
|
Behavioral: Nutrition Counselling
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549367
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549367
Contacts
| Contact: Simon J Sadler | +61293329722 | Simon.Sadler@sesiahs.health.nsw.gov.au | |
| Contact: Nittaya Phanuphak | +662253 0996 | Nittaya.P@chula.ac.th |
Locations
| Thailand | |
| Thai Red Cross AIDS Research Centre | Recruiting |
| Bangkok, Pathumwan, Thailand, 10330 | |
| Contact: Nittaya Phanuphak +662253 0996 Nittaya.P@chula.ac.th | |
| Contact: Chintana Chaturawit +662253 0996 cchaturawit@yahoo.com | |
| Sub-Investigator: Nittaya Phanuphak | |
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Albion Street Centre
Mahidol University
Investigators
| Principal Investigator: | Simon J Sadler | Albion Street Centre |
More Information
| Responsible Party: | Simon Sadler, Albion Street Centre |
| ClinicalTrials.gov Identifier: | NCT00549367 History of Changes |
| Other Study ID Numbers: | TACHIN001 |
| Study First Received: | October 23, 2007 |
| Last Updated: | April 21, 2016 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Thai Red Cross AIDS Research Centre:
|
Nutritional status Nutrition counselling Nutrition assessment |
HIV Alternative Medicine Complementary Medicine |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016