Clinical trial NCT06595225: Nutrition Education Intervention for PLHIV
Official title: Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai, UAE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Nutritional Deficiency
Keywords: Nutrition education
HIV
PLHIV
Intervention
Knowledge. attitude, practices
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned randomly into either the control or intervention group based on 4 aspects which were: gender, 0 co-morbidities, 1 co-morbidity, 2 or more co-morbidities, whereas the interventional group received nutrition education sessions of various topics related to general nutrition knowledge, with more focus on nutrition related to patients living with HIV (PLHIV) for a 6 months period, were there was one encounter per month and follow up was weekly over a social media platform (Whatsapp)
Primary purpose: SUPPORTIVE_CARE

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 patient's 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 individual's 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.

Eligibility criteria: Inclusion Criteria

The inclusion criteria were patients of:

* more or equal to 18 years of age;
* Who have the virus with or without any co-morbidities;
* And who give consent to participate.

Exclusion Criteria:

* Patients who are imprisoned;
* And/or refuse to participate were excluded.

Disclaimer: prisoners were excluded as their confinement and lack of access will hinder them from receiving the intervention.

Primary outcomes:
measure: KAP score (knowledge, attitude, and practices)
timeFrame: 6 months
measure: Improve in intake of immune boosting nutrients
timeFrame: 6 months
Secondary outcomes:
measure: Improve in physical activity
timeFrame: in 6 months
measure: Body mass index (BMI) reduction
timeFrame: 6 months
measure: Improving nutrition-related biochemical data
timeFrame: in 6 months
Other outcomes:
measure: Change of mental health through hospital anxiety and depression scale (HADS)
timeFrame: in 6 months
Locations:
city: Dubai
country: United Arab Emirates
facility: Dubai Health - Rashid Hospital
Study officials:
References: