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

October 23, 2007
September 20, 2009
November 2007
December 2010   (final data collection date for primary outcome measure)
body composition measured by BIA and anthropometry [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
body composition measured by BIA and anthropometry [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00549367 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
HIV Infections
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
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
Intervention: Behavioral: Nutrition Counselling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
153
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Simon J Sadler +61293329722 Simon.Sadler@sesiahs.health.nsw.gov.au
Contact: Nittaya Phanuphak +662253 0996 Nittaya.P@chula.ac.th
Thailand
 
NCT00549367
TACHIN001
No
Simon Sadler, Albion Street Centre
Thai Red Cross AIDS Research Centre
  • Albion Street Centre
  • Mahidol University
Principal Investigator: Simon J Sadler Albion Street Centre
Thai Red Cross AIDS Research Centre
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP