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| ID | Type | Description | Link |
|---|---|---|---|
| IRB26-0319 | Other Identifier | University of Illinois Urbana-Champaign | |
| IRB25-1474 | Other Identifier | King Abdullah Medical City (KAMC), Saudi Arabia |
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| Name | Class |
|---|---|
| King Abdullah Medical City | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle and Dietary Intervention (LDI) | Experimental | Participants in this group will receive a 6-month online lifestyle and dietary intervention consisting of 12 Arabic-language educational sessions. The program includes guidance on healthy eating, behavior change, and weight management, along with optional support from dietitians and regular feedback on progress. |
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| Usual Care | Active Comparator | Participants in this group will receive standard hospital-based dietary care, including a personalized dietary plan based on their medical needs and routine clinical follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Lifestyle and Dietary Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight in kilograms measured from baseline to follow-up visits. | Baseline, 3 Months, and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist and Hip Circumference | Change in waist and hip circumference measured in centimeters from baseline to follow-up visits. | Baseline, 3 Months, and 6 Months |
| Change in Dietary Intake |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Manabu Nakamura, PhD, DVM | University of Illinois Urbana-Champaign | Principal Investigator |
| Asma Yahya, MS | University of Illinois at Urbana-Champaign | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdullah Medical City | Mecca | Mecca Region | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39372722 | Background | 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. | |
| 28578444 | Background |
| Label | URL |
|---|---|
| Background information on the EMPOWER dietary weight loss program that informed this study intervention. | View source |
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De-identified individual participant data underlying the results reported in publications from this study will be made available. This may include baseline characteristics, anthropometric outcomes, dietary intake measures, and quality-of-life questionnaire data collected during the trial. No directly identifiable participant information will be shared.
De-identified data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years thereafter.
Access will be provided to qualified researchers whose proposed use of the data has been reviewed and approved by the study investigators. Requests must include a methodologically sound proposal and may be subject to a data use agreement. Only de-identified data and approved supporting documents will be shared, in accordance with institutional policies and applicable ethical and regulatory requirements.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Participants will be randomized in parallel to either a 6-month online lifestyle and dietary intervention group or a usual care group receiving standard hospital-based dietary care.
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| Usual Dietary Care | Behavioral | Standard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up. |
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Changes in dietary intake, including calorie intake and protein and fiber density, assessed using dietary records and food frequency questionnaire.
| Baseline, Monthly Dietary Records, and 6 Months |
| Change in Health-Related Quality of Life | Changes in health-related quality of life measured using the RAND 36-Item Health Survey (RAND-36). | Baseline and 6 Months |
| 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. |
| 9520966 | Background | 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. |
| 38803427 | Background | 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. |
| 35617305 | Background | 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. |
| 8275167 | Background | 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. |
| Research lab website for the study team and related work in dietary and lifestyle intervention research. | View source |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |