Dubai Health - Rashid Hospital
Dubai, United Arab Emirates
NCT Number: NCT06595225
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Dubai, United Arab Emirates
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The inclusion criteria were patients of:
Exclusion criteria
Disclaimer: prisoners were excluded as their confinement and lack of access will hinder them from receiving the intervention.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: in 6 months
Change of the overall mental health status of PLHIV.
Screening of mental health was done using the questionnaire Hospital Anxiety and Depression Scale (HADS) used to assess the prevalence of anxiety and depression. A score of 0-7 is normal, 8-10 mild anxiety/depression, 11-14 moderate anxiety/depression, 15-21 severe anxiety/depression. A validated Arabic version of the questionnaire was used on Arabic-speaking patients. A HADS score on each sub-section above 11 is elevated and needs further assessment by a psychologist.
United Arab Emirates University
Other
Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai, UAE
Acronym: 202372
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03734393
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Birmingham, Alabama, United States
View Trial DetailsNCT06176859
ART, Acquired Immunodeficiency Syndrome
Durban, KwaZulu-Natal, South Africa
View Trial DetailsNCT06139354
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05911360
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Phoenix, Arizona, United States
View Trial Details