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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Nutrition Counselling
Sponsored by
Thai Red Cross AIDS Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring Nutritional status, Nutrition counselling, Nutrition assessment, HIV, Alternative Medicine, Complementary Medicine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thai Red Cross AIDS Research Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

body composition measured by BIA and anthropometry

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

Full Information

First Posted
October 23, 2007
Last Updated
February 15, 2023
Sponsor
Thai Red Cross AIDS Research Centre
Collaborators
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00549367
Brief Title
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
Acronym
TACH001
Official Title
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2007 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
February 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thai Red Cross AIDS Research Centre
Collaborators
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Nutritional status, Nutrition counselling, Nutrition assessment, HIV, Alternative Medicine, Complementary Medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Nutrition Counselling
Intervention Description
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
Primary Outcome Measure Information:
Title
body composition measured by BIA and anthropometry
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon J Sadler
Organizational Affiliation
Albion Street Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thai Red Cross AIDS Research Centre
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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