Online Dietary Weight Loss Program for Arab Adults: A Randomized Controlled Trial

Официальное название

Testing an Online Dietary Weight Loss Program for Arab Adults: A Comparative Study With Existing Hospital-Based Weight Loss Interventions in Saudi Arabia

Обзор

This study is testing whether a culturally adapted online dietary and lifestyle program can help Arab adults in Saudi Arabia lose weight and improve their overall health. Participants will be randomly assigned to one of two groups: an online lifestyle and dietary intervention group or a usual care group receiving standard hospital-based dietary care. The online program lasts 6 months and includes 12 Arabic-language educational sessions, practical guidance on healthy eating and lifestyle habits, and support from dietitians when needed. The usual care group will receive personalized dietary advice as normally provided in the hospital setting. Researchers will compare the two groups to see how the program affects body weight, dietary habits, and quality of life over time. The goal of this study is to identify an effective and accessible weight management approach for Arab adults in Saudi Arabia.

Подробное описание

Obesity is a growing public health concern in Saudi Arabia and is associated with increased risk of chronic conditions such as type 2 diabetes, hypertension, and cardiovascular disease. Although hospital-based weight management services are available, access to structured, culturally relevant, and sustainable dietary support remains limited for many adults. Online interventions may offer a practical and scalable alternative, particularly when they are tailored to local language, culture, and eating habits.

This study will evaluate a culturally adapted online dietary and lifestyle intervention designed for Arab adults in Saudi Arabia. The intervention was developed based on the EMPOWER weight loss program and revised using participant feedback from a prior Saudi pilot study. The current version includes Arabic-language educational content, Saudi food examples, visual tools to support food choices, and ongoing support for behavior change and weight management.

Participants will be randomly assigned to either the online lifestyle and dietary intervention group or the usual care group. The online intervention will be delivered over 6 months and will include 12 educational sessions, practical dietary guidance, and individualized support from dietitians when needed. Participants in the usual care group will receive the standard dietary care available through the hospital.

Study outcomes will include changes in body weight, waist and hip circumference, dietary intake, and health-related quality of life over time. The findings from this trial may help identify an effective, accessible, and culturally appropriate model for obesity treatment in Arab populations.

Вмешательства

• Поведенческое Online Lifestyle and Dietary Program
  A culturally adapted, 6-month online program designed for Arab adults that includes 12 educational sessions, practical dietary guidance, and tools to support sustainable lifestyle changes and weight management. Participants may also receive support from dietitians and feedback on dietary and weight progress.
• Поведенческое Usual Dietary Care
  Standard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up.

Первичные конечные точки

• Change in Body Weight [Срок оценки: Baseline, 3 Months, and 6 Months]

Вторичные конечные точки (3)

• Change in Waist and Hip Circumference [Срок оценки: Baseline, 3 Months, and 6 Months]
• Change in Dietary Intake [Срок оценки: Baseline, Monthly Dietary Records, and 6 Months]
• Change in Health-Related Quality of Life [Срок оценки: Baseline and 6 Months]

Критерии участия

Критерии включения

Adults aged 18 to 75 years Arabic-speaking Body mass index (BMI) ≥25 kg/m² Have at least one obesity-related comorbidity, such as hypertension, type 2 diabetes, hyperlipidemia, or joint-related problems Own a smartphone Have Wi-Fi/internet access at home Willing to participate in a 6-month study Willing to attend 12 educational sessions if assigned to the intervention group Able to provide informed consent

Критерии исключения

Currently pregnant or breastfeeding Planning pregnancy during the study period Currently using weight loss medications (including GLP-1 medications) History of bariatric surgery Planning bariatric surgery during the study period Currently participating in another structured weight loss program Severe medical conditions that may make participation unsafe, such as serious renal disease or other unstable health conditions Limited ability to use online materials or complete digital assessments independently

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• King Abdullah Medical City — Mecca

Публикации

• Oliveira A, Alfouzan N, Yu J, Yahya A, Lammy K, Wright ML, Reinhold D, Peterson L, Brewer A, Liechty J, Nakamura MT. Feasibility and acceptability pilot study of an online weight loss program in rural, underserved communities. PeerJ. 2024 Oct 3;12:e18268. doi: 10.7717/peerj.18268. eCollection 2024. PMID 39372722
• Gosadi IM, Alatar AA, Otayf MM, AlJahani DM, Ghabbani HM, AlRajban WA, Alrsheed AM, Al-Nasser KA. Development of a Saudi Food Frequency Questionnaire and testing its reliability and validity. Saudi Med J. 2017 Jun;38(6):636-641. doi: 10.15537/smj.2017.6.20055. PMID 28578444
• Coons SJ, Alabdulmohsin SA, Draugalis JR, Hays RD. Reliability of an Arabic version of the RAND-36 Health Survey and its equivalence to the US-English version. Med Care. 1998 Mar;36(3):428-32. doi: 10.1097/00005650-199803000-00018. PMID 9520966
• Lee MH, Shaffer A, Alfouzan NW, Applegate CC, Hsu JC, Erdman JW Jr, Nakamura MT. Successful dietary changes correlate with weight-loss outcomes in a new dietary weight-loss program. Obes Sci Pract. 2024 May 27;10(3):e764. doi: 10.1002/osp4.764. eCollection 2024 Jun. PMID 38803427
• Lee MH, Applegate CC, Shaffer AL, Emamaddin A, Erdman JW Jr, Nakamura MT. A feasibility study to test a novel approach to dietary weight loss with a focus on assisting informed decision making in food selection. PLoS One. 2022 May 26;17(5):e0267876. doi: 10.1371/journal.pone.0267876. eCollection 2022. PMID 35617305
• Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305. PMID 8275167

Идентификаторы

NCT: NCT07518875 · UIllinoisUI · IRB26-0319 · IRB25-1474

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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