Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595225
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Nutrition Education Intervention for PLHIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai UAE
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
202372
Brief Summary:
The study tested two hypotheses which are mentioned below
Hypotheses The project will test 5 hypotheses related to the various aspects of the study
H1 implementing a nutrition education intervention will significantly improve the patients nutritional knowledge dietary practices and attitudes KAP post-6 months of intervention
H2 implementing a nutrition education intervention will significantly improve the patients food intake of immune-boosting foods physical activity levels anthropometric measurements nutrition-related biochemical biomarkers and mental health status post the intervention period
Note H2 is a complex hypothesis consisting of 5 sub-hypotheses corresponding to the five mentioned measurements food intake of immune-boosting foods physical activity levels anthropometric measurements nutrition-related biochemical biomarkers and mental health status Each of these sub-hypotheses will be statistically tested
Hypotheses The project will test 5 hypotheses related to the various aspects of the study
H1 implementing a nutrition education intervention will significantly improve the patients nutritional knowledge dietary practices and attitudes KAP post-6 months of intervention
H2 implementing a nutrition education intervention will significantly improve the patients food intake of immune-boosting foods physical activity levels anthropometric measurements nutrition-related biochemical biomarkers and mental health status post the intervention period
Note H2 is a complex hypothesis consisting of 5 sub-hypotheses corresponding to the five mentioned measurements food intake of immune-boosting foods physical activity levels anthropometric measurements nutrition-related biochemical biomarkers and mental health status Each of these sub-hypotheses will be statistically tested
Detailed Description:
The intervention was guided by the Health Belief model The topics to be covered and the content of the educational program were designed with input from dietitians working with PLHIV to ensure the relevance for the target participants Participants randomized into the intervention group received individualized sessions with a registered dietitian once a month for 6 months During the sessions the dietitian elaborated on the medical nutrition therapy for each participant which consists of nutritional diagnosis and nutritional counseling services Topics covered include general nutrition knowledge MyPlate food groups immune-boosting foods and nutrients improving physical activity levels the nutritional aspects of the existing co-morbidities such as hypertension diabetes etc The intervention provided by the dietitian primary investigator which was guided by the Health Belief Model HBM which suggests that an individuals beliefs about health threats perceived benefits of acting and perceived barriers to acting are key determinants of health-related behaviors Each session lasted for approximately 30-45 minutes through virtual platforms or in-person or a combination of both using several teaching tools such as discussions demonstrations educational materials and educational videos
The participants were met with online once per month and they were followed up on weekly basis on Whatsapp to reinforce the last session message
The participants were met with online once per month and they were followed up on weekly basis on Whatsapp to reinforce the last session message
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None