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临床试验/NCT06595225
NCT06595225已完成不适用

Lifestyle and Nutrition Intervention for Patients Living with HIV Attending an Outpatient Clinic in Dubai, UAE

United Arab Emirates University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
KAP score (knowledge, attitude, and practices)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

KAP score (knowledge, attitude, and practices)

时间窗: 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

时间窗: 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).

次要结局

  • Improve in physical activity(in 6 months)
  • Body mass index (BMI) reduction(6 months)
  • Improving nutrition-related biochemical data(in 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Souheir Alia

Clinical dietitian and PhD candidate

United Arab Emirates University

研究点 (1)

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