Nutrition Education Intervention for PLHIV

NCT06595225 | Completed DMC

• 1 other identifier: 202372
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Nutritional Deficiency

Keywords

Nutrition education; HIV; PLHIV; Intervention; Knowledge. attitude, practices

Outcome Measures

Primary Outcomes (2)

• KAP score (knowledge, attitude, and practices)

  improving the overall nutrition-related knowledge and its reflection on patients' dietary knowledge, attitudes, and practices. The data was collected face-to-face using a questionnaire adapted from the relevant literature including questions related to nutrition knowledge, attitude, and practices (KAP) of HIV patients attending an outpatient clinic in India. This questionnaire assessed all 3 aspects, where the score ranges of knowledge, attitude, and practices are 0-14, 14-42, and 0-13, respectively. The total score of all three subsections ranges between 13-69 where a score between 13 and 32 represents poor KAP values, 33-51 average, and 52-69 good values. The original scores were modified in our study based on face and content validity results.

  6 months

• Improve in intake of immune boosting nutrients

  Improving the food intake of immune-boosting foods and food groups (e.g.: fruits and vegetables, protein-containing food groups). Two-non-consecutive days 24-hour dietary recalls was used both pre- and post-intervention to measure the intake of total calories and protein as well as nutrients of immune-boosting properties (Vitamin A, Vitamin C, Vitamin E, Vitamin D, Selenium, Zinc, omega 3 omega 6 fatty acids, Iron). Additionally, a qualitative food frequency questionnaire was developed from the literature on the immune-boosting food groups. It was used to measure the change in intake of the immune-boosting food groups pre- and post-intervention period. It covered 10 components (fruits, vegetables, animal-derived protein food sources, plant-based protein food sources, whole grains, nuts, seeds, probiotic-rich foods, herbs, plant-based monounsaturated fatty acids rich oils, plant-based polyunsaturated fatty acids rich oils).

  6 months

Secondary Outcomes (3)

• Improve in physical activity

  in 6 months

• Body mass index (BMI) reduction

  6 months

• Improving nutrition-related biochemical data

  in 6 months

Other Outcomes (1)

• Change of mental health through hospital anxiety and depression scale (HADS)

  in 6 months

Study Arms (2)

Nutrition Education Sessions Group

EXPERIMENTAL

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.

Behavioral: Nutrition education sessions

Control group

NO INTERVENTION

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

Interventions

Nutrition education sessions 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.

Nutrition Education Sessions Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

Dubai Health - Rashid Hospital

Dubai, Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Malnutrition

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical dietitian and PhD candidate

Model Details: 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)

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: August 28, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)