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Enrolling by Invitation

NCT Number: NCT07518875

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah Medical City

Mecca, Mecca Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Dietary Care

Behavioral

Standard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Asma Yahya

Other

Collaborators

  • King Abdullah Medical City

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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