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

Sponsored by:	Thai Red Cross AIDS Research Centre
Information provided by:	Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:	NCT00549367

Purpose

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	Intervention	Phase
HIV Infections	Behavioral: Nutrition Counselling	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:

body composition measured by BIA and anthropometry [ Time Frame: 48 weeks ]

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 [ Time Frame: 48 weeks ]

Estimated Enrollment:	153
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549367

Contacts

Contact: Simon J Sadler	+61293329722	Simon.Sadler@sesiahs.health.nsw.gov.au
Contact: Nittaya Phanuphak	+662253 0996	Nittaya.P@chula.ac.th

Locations

Thailand, Pathumwan
Thai Red Cross AIDS Research Centre
Bangkok, Pathumwan, Thailand, 10330

Sponsors and Collaborators

Thai Red Cross AIDS Research Centre

Investigators

Principal Investigator:

Simon J Sadler

Albion Street Centre

More Information

Study ID Numbers:	TACHIN001
Study First Received:	October 23, 2007
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00549367
Health Authority:	Thailand: Ethical Committee

Keywords provided by Thai Red Cross AIDS Research Centre:

Nutritional status
Nutrition counselling
Nutrition assessment

HIV
Alternative Medicine
Complementary Medicine

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009