Hiv202372NCT06595225
Nutrition Education Intervention for PLHIV
A study testing Nutrition education sessions in people with Hiv and Nutritional Deficiency, run by United Arab Emirates University at 1 site in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Nutritional Deficiency
- What is being tested?
- Nutrition education sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Dubai Health - Rashid Hospital
Dubai, Dubai
About this study
Official title: Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai, UAE
The study tested two hypotheses, which are mentioned below:
Hypotheses: The project will test 5 hypotheses related to the various aspects of the study.
Read more
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.
Read the 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.
- Conditions
- Hiv, Nutritional Deficiency
- Being tested
- Nutrition education sessions
- Keywords
- Nutrition education, HIV, PLHIV, Intervention, Knowledge. attitude, practices
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition education sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutrition education sessions |
| Control group | No intervention | this group did not receive the intervention that the experimental group received |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 months
Secondary outcomes (3)
Improve in physical activity
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.
Measured: in 6 months
Body mass index (BMI) reduction
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.
Measured: 6 months
Improving nutrition-related biochemical data
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
Measured: in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Aug 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souheir Alia, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595225
- Sponsor's protocol ID
- 202372
- Acronym
- 202372
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai, UAE
- ClinicalTrials.gov ID
- NCT06595225
- Acronym / sponsor ID
- 202372 / 202372
- Conditions
- Hiv, Nutritional Deficiency
- Keywords
- Nutrition education, HIV, PLHIV, Intervention, Knowledge. attitude, practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education Sessions Group | Experimental | Behavioral: Nutrition education sessionsthis 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. |
| Control group | No intervention | –this group did not receive the intervention that the experimental group received |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more or equal to 18 years of age;
- Who have the virus with or without any co-morbidities;
- And who give consent to participate.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition education sessionsParticipants 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. | Behavioural | Nutrition Education Sessions Group |
Primary outcome
KAP score (knowledge, attitude, and practices)
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.
Improve in intake of immune boosting nutrients
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).
3 secondary outcomes
Improve in physical activity
Time frame: in 6 months
Body mass index (BMI) reduction
Time frame: 6 months
Improving nutrition-related biochemical data
Time frame: in 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education sessions in people with Hiv and Nutritional Deficiency, run by United Arab Emirates University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KAP score (knowledge, attitude, and practices) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.