- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518875
Online Dietary Weight Loss Program for Arab Adults: A Randomized Controlled Trial
Testing an Online Dietary Weight Loss Program for Arab Adults: A Comparative Study With Existing Hospital-Based Weight Loss Interventions in Saudi Arabia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mecca Region
-
Mecca, Mecca Region, Saudi Arabia
- King Abdullah Medical City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle and Dietary Intervention (LDI)
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.
|
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.
|
|
Active Comparator: Usual Care
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.
|
Standard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline, 3 Months, and 6 Months
|
Change in body weight in kilograms measured from baseline to follow-up visits.
|
Baseline, 3 Months, and 6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Waist and Hip Circumference
Time Frame: Baseline, 3 Months, and 6 Months
|
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
Time Frame: Baseline, Monthly Dietary Records, and 6 Months
|
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
Time Frame: Baseline and 6 Months
|
Changes in health-related quality of life measured using the RAND 36-Item Health Survey (RAND-36).
|
Baseline and 6 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manabu Nakamura, PhD, DVM, University of Illinois Urbana-Champaign
- Study Director: Asma Yahya, MS, University of Illinois at Urbana-Champaign
Publications and helpful links
General Publications
- 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.
- Oliveira, A., Alfouzan, N., Yu, J., Yahya, A., Lammy, K., Wright, M. L., Reinhold, D., Peterson, L., Brewer, A., Liechty, J., & Nakamura, M. T. (2024). Feasibility and acceptability pilot study of an online weight loss program in rural, underserved communities. PeerJ, 12, e18268. https://doi.org/10.7717/peerj.18268
- Gosadi, I. M., Alatar, A. A., Otayf, M. M., AlJahani, D. M., Ghabbani, H. M., AlRajban, W. A., Alrsheed, A. M., & Al-Nasser, K. A. (2017). Development of a Saudi Food Frequency Questionnaire and testing its reliability and validity. Saudi medical journal, 38(6), 636-641. https://doi.org/10.15537/smj.2017.6.20055
- Coons, S. J., Alabdulmohsin, S. A., Draugalis, J. R., & Hays, R. D. (1998). Reliability of an Arabic version of the RAND-36 Health Survey and its equivalence to the US-English version. Medical care, 36(3), 428-432. https://doi.org/10.1097/00005650-199803000-00018
- Lee, M.H., et al., Successful dietary changes correlate with weight-loss outcomes in a new dietary weight-loss program. Obes Sci Pract, 2024. 10(3): p. e764.
- Hays, R.D., C.D. Sherbourne, and R.M. Mazel, The RAND 36-Item Health Survey 1.0. Health Econ, 1993. 2(3): p. 217-27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UIllinoisUI
- IRB26-0319 (Other Identifier: University of Illinois Urbana-Champaign)
- IRB25-1474 (Other Identifier: King Abdullah Medical City (KAMC), Saudi Arabia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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