Nutrition Education Intervention for PLHIV

NCT ID: NCT06595225

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Hiv Nutritional Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutrition Education Sessions Group

this group received nutrition education sessions each month for a period of 6 months. Where they were followed up once a week via Whatsapp, reminded of the previous session's message and had their questions answered.

Group Type EXPERIMENTAL

Nutrition education sessions

Intervention Type BEHAVIORAL

Participants received nutrition education each month, covering topics ranging from general nutrition knowledge, nutrition knowledge related to their diagnosis of living with HIV infection whether during the acute or chronic phase. In addition, specific information was shared about other comorbidities the participant could be living with, finally information was shared on ways to improve mental health and enhance physical activity levels.

Control group

this group did not receive the intervention that the experimental group received

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition education sessions

Participants received nutrition education each month, covering topics ranging from general nutrition knowledge, nutrition knowledge related to their diagnosis of living with HIV infection whether during the acute or chronic phase. In addition, specific information was shared about other comorbidities the participant could be living with, finally information was shared on ways to improve mental health and enhance physical activity levels.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Arab Emirates University

OTHER

Sponsor Role lead

Responsible Party

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Souheir Alia

Clinical dietitian and PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dubai Health - Rashid Hospital

Dubai, Dubai, United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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202372

Identifier Type: -

Identifier Source: org_study_id

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