NCT00549367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

July 1, 2021

Enrollment Period

15.1 years

First QC Date

October 23, 2007

Last Update Submit

February 15, 2023

Conditions

Keywords

Nutritional statusNutrition counsellingNutrition assessmentHIVAlternative MedicineComplementary Medicine

Outcome Measures

Primary Outcomes (1)

  • body composition measured by BIA and anthropometry

    48 weeks

Secondary Outcomes (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

    48 weeks

Study Arms (1)

1

OTHER

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

Interventions

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thai Red Cross AIDS Research Centre

Bangkok, Pathumwan, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Simon J Sadler

    Albion Street Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 25, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

February 17, 2023

Record last verified: 2021-07

Locations