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

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ClinicalTrials.gov Identifier: NCT00549367
Recruitment Status : Active, not recruiting
First Posted : October 25, 2007
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Albion Street Centre
Mahidol University
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Nutrition Counselling Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 2007
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. body composition measured by BIA and anthropometry [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549367


Locations
Thailand
Thai Red Cross AIDS Research Centre
Bangkok, Pathumwan, Thailand, 10330
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT00549367     History of Changes
Other Study ID Numbers: TACHIN001
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

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