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

February 15, 2023 updated by: Thai Red Cross AIDS Research Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumwan
      • Bangkok, Pathumwan, Thailand, 10330
        • Thai Red Cross Aids Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body composition measured by BIA and anthropometry
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Red Cross AIDS Research Centre

Collaborators

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

October 23, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACHIN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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