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

NCT07518875 | Enrolling By Invitation

• 3 other identifiers: UIllinoisUIIRB26-0319IRB25-1474
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Overweight and Obesity

Keywords

Obesity Weight Loss Online Dietary Program Lifestyle Intervention Arab Adults Saudi Arabia Nutrition Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Change in body weight in kilograms measured from baseline to follow-up visits.

  Baseline, 3 Months, and 6 Months

Secondary Outcomes (3)

• Change in Waist and Hip Circumference

  Baseline, 3 Months, and 6 Months

• Change in Dietary Intake

  Baseline, Monthly Dietary Records, and 6 Months

• Change in Health-Related Quality of Life

  Baseline and 6 Months

Study Arms (2)

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.

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.

Behavioral: Usual Dietary Care

Interventions

Usual Dietary Care BEHAVIORAL

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

Usual Care

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.

Lifestyle and Dietary Intervention (LDI)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asma Yahya: lead
• King Abdullah Medical City: collaborator

Study Sites (1)

King Abdullah Medical City

Mecca, Mecca Region, Saudi Arabia

Location

Related Publications (6)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  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.

  PMID: 35617305 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Background information on the EMPOWER dietary weight loss program that informed this study intervention.
• Research lab website for the study team and related work in dietary and lifestyle intervention research.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manabu Nakamura, PhD, DVM

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

• Asma Yahya, MS

  University of Illinois at Urbana-Champaign

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Student - Main Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 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 Criteria: 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.

Locations

SA (1)