Nutrition Education Intervention for PLHIV

Not Applicable

Completed

• Conditions: Hiv; Nutritional Deficiency
• Interventions: Behavioral: Nutrition education sessions

• Registration Number: NCT06595225
• Lead Sponsor: United Arab Emirates University

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.

Study Timeline

• Study Start: 2023-08-28
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2024-08-27
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Education Sessions Group	Nutrition education sessions	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.

Primary Outcome Measures

Name	Time	Method
KAP score (knowledge, attitude, and practices)	6 months	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.
Improve in intake of immune boosting nutrients	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Improve in physical activity	in 6 months	Improving the physical activity levels and anthropometric measurements of PLHIV.; Physical activity level (active versus inactive) was determined using a questionnaire developed by the American College of Sports Medicine for assessing the physical activity level of patients in clinical settings, namely the "Physical Vital Sign Questionnaire". The physically active versus inactive status is determined following the Physical Activity Guidelines for Americans, 2023, which recommend a physical activity level for adults of 150 minutes of moderate-intensity physical activity and 2 days of muscle-strengthening activity.; Any participant performing any kind of physical activity for 150 minutes/week as well as 2-3 days of muscle strengthening workouts is considered physically active. Any participant below 150 minutes/week and no strength training whatsoever is considered physically inactive.
Body mass index (BMI) reduction	6 months	The measurements of weight is kilograms and the height in centimeter will be aggregated to arrive at one reported value which is BMI in Kg/m\^2.
Improving nutrition-related biochemical data	in 6 months	Improving the nutrition-related biochemical lab values in relation to adjustment of patients' dietary and lifestyle factors.; Biochemical measurements were collected from the patient's medical files pre- and post-intervention for both control and intervention group.; Reference Range for each biochemical parameter: Viral load: Ref not detected (Negative) copies/mL. CD4: Ref 219 - 1,621 CELL/uL. Hemoglobin: Ref males 13.0 - 17.0 g/dL versus females 12.0-15.0 g/dL. ALT: Ref males 0-41 U/L versus females 0-31 U/L. AST: Ref males 0-40 U/L versus females 0-32 U/L. Creatinine: Ref: males 0.7-1.2 mg/dL versus females 0.5-0.9 mg/dL. Urea: Ref 12-40 mg/dL. HbA1c: Ref more than5.7% - 5.7-6.4% prediabetes - \>=6.5 diabetes. eGFR: Ref more than 60 mL/min/1.73(2) VitaminD3: Ref 30-100 ng/mL. LDL: Ref less than 115 mg/dL HDL: Ref above40 mg/dL men, above 48 mg/dL women. Triglyceride: Ref less than 90 mg/dL

Trial Locations

Locations (1)

Dubai Health - Rashid Hospital; 🇦🇪 Dubai, United Arab Emirates