The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Thai Red Cross AIDS Research Centre.
Recruitment status was  Recruiting
Sponsor:
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: September 20, 2009
Last verified: September 2009
  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 2010
Estimated Primary Completion Date: December 2010 (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
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

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

No publications provided

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: September 20, 2009
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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 01, 2014