Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-28 @ 2:10 PM
Study NCT ID:
NCT00549367
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2007-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2007-10-23', 'studyFirstSubmitQcDate': '2007-10-24', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body composition measured by BIA and anthropometry', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional status', 'Nutrition counselling', 'Nutrition assessment', 'HIV', 'Alternative Medicine', 'Complementary Medicine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive\n* 18 years of age or older\n* Receiving ongoing care as part of the TRCARC Family Clinic (TRCARC Wellness Plus clinic)\n* Either ART naive or have been on stable ART for more than 6 months\n\nExclusion Criteria:\n\n* HIV negative\n* Unintentional weight loss of more than 10% usual body weight, or BMI\\<17\n* BMI\\>30\n* Suspected or documented HIV related opportunistic infection\n* Pregnant women\n* Women less than 3 months post-partum'}, 'identificationModule': {'nctId': 'NCT00549367', 'acronym': 'TACH001', 'briefTitle': 'The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Thai Red Cross AIDS Research Centre'}, 'officialTitle': 'The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)', 'orgStudyIdInfo': {'id': 'TACHIN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', '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', 'interventionNames': ['Behavioral: Nutrition Counselling']}], 'interventions': [{'name': 'Nutrition Counselling', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Pathumwan', 'country': 'Thailand', 'facility': 'Thai Red Cross AIDS Research Centre', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Simon J Sadler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albion Street Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}