Overweight and ObesityNCT07518875
Online Dietary Weight Loss Program for Arab Adults: A Randomized Controlled Trial
A study testing Online Lifestyle and Dietary Program and Usual Dietary Care in people with Overweight and Obesity, run by Asma Yahya at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Online Lifestyle and Dietary Program and Usual Dietary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 9 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Online Lifestyle and Dietary Program, Usual Dietary Care
- Keywords
- Obesity Weight Loss Online Dietary Program Lifestyle Intervention Arab Adults Saudi Arabia Nutrition Randomized Controlled Trial
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Lifestyle and Dietary ProgramBehavioural
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 CareBehavioural
Standard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Lifestyle and Dietary Program |
| 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. Receives: Behavioral: Usual Dietary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight in kilograms measured from baseline to follow-up visits.
Measured: Baseline, 3 Months, and 6 Months
Secondary outcomes (3)
Change in Waist and Hip Circumference
Change in waist and hip circumference measured in centimeters from baseline to follow-up visits.
Measured: Baseline, 3 Months, and 6 Months
Change in Dietary Intake
Changes in dietary intake, including calorie intake and protein and fiber density, assessed using dietary records and food frequency questionnaire.
Measured: 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).
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start9 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asma Yahya
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdullah Medical City
- Responsible party
- Sponsor-investigator, Asma Yahya, University of Illinois at Urbana-Champaign
- Investigators
- Manabu Nakamura, PhD, DVM, Principal investigator, University of Illinois Urbana-ChampaignAsma Yahya, MS, Study director, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518875
- Sponsor's protocol ID
- UIllinoisUI
- Other IDs
- IRB26-0319, IRB25-1474
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39372722Gosadi 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.
PubMed 28578444Coons 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.
PubMed 9520966Lee 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.
PubMed 38803427Lee 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.
PubMed 35617305Hays 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.
PubMed 8275167
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Online Dietary Weight Loss Program for Arab Adults: A Comparative Study With Existing Hospital-Based Weight Loss Interventions in Saudi Arabia
- ClinicalTrials.gov ID
- NCT07518875
- Acronym / sponsor ID
- UIllinoisUI
- Conditions
- Overweight and Obesity
- Keywords
- Obesity Weight Loss Online Dietary Program Lifestyle Intervention Arab Adults Saudi Arabia Nutrition Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Asma YahyaUniversity, hospital or other
- Collaborators
- King Abdullah Medical City
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and Dietary Intervention (LDI) | Experimental | Behavioral: Online Lifestyle and Dietary ProgramParticipants 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. |
| Usual Care | Active comparator | Behavioral: Usual Dietary CareParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Lifestyle and Dietary ProgramA 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. | Behavioural | Lifestyle and Dietary Intervention (LDI) |
| Usual Dietary CareStandard dietary care provided in the hospital setting, including individualized dietary recommendations based on clinical assessment and routine follow-up. | Behavioural | Usual Care |
Primary outcome
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.
3 secondary outcomes
Change in Waist and Hip Circumference
Time frame: Baseline, 3 Months, and 6 Months
Change in Dietary Intake
Time frame: Baseline, Monthly Dietary Records, and 6 Months
Change in Health-Related Quality of Life
Time frame: Baseline and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 39372722Oliveira 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.
- Background: PubMed 28578444Gosadi 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.
- Background: PubMed 9520966Coons 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.
- Background: PubMed 38803427Lee 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.
- Background: PubMed 35617305Lee 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.
- Background: PubMed 8275167Hays 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.
- Background information on the EMPOWER dietary weight loss program that informed this study intervention.Link provided by the sponsor.
- Research lab website for the study team and related work in dietary and lifestyle intervention research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manabu Nakamura, PhD, DVM principal investigator
University of Illinois Urbana-Champaign
Asma Yahya, MS study director
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Lifestyle and Dietary Program and Usual Dietary Care in people with Overweight and Obesity, run by Asma Yahya at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, 3 Months, and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07518875, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.