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
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
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
NCT ID
NCT00549367
First Posted
October 23, 2007
Last Updated
February 15, 2023
Sponsor
Thai Red Cross AIDS Research Centre
Collaborators
Mahidol University
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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