Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations

Overweight and Obesity Clinical Trial

Official title:

Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations: Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06415695
• Other study ID #: IRB23-0344
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Asma M Yahya, Master
• Phone: 2177224045
• Email: yahya2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop and test a culturally tailored online weight loss program for the Saudi population. Building upon the success of a previous program in the United States, the research team will adapt educational materials and conduct a pilot study to assess the feasibility and initial outcomes of the program among Arab participants. The study seeks to answer questions about the program's acceptability, effectiveness, and scalability, with the ultimate goal of combating obesity and its related health issues in Saudi Arabia.

Description:

This research project aims to help Saudi individuals lose weight in a way that suits their culture. Obesity is a significant problem and can lead to serious health issues like diabetes and heart problems. Even though Saudi Arabia has attempted to help individuals lose weight before, previous efforts haven't been successful enough. Therefore, the investigators aim to develop a new weight loss program that is better suited to Saudi individuals.

First, educational materials will be created in Arabic to teach individuals how to eat better and live healthier. Then, collaboration will be undertaken with individuals in Saudi Arabia to ensure the program fits their needs. Afterward, the program will be tested with a small group of individuals to evaluate its effectiveness and acceptability.

Approximately 20 individuals will be invited to join the program at King Abdullah Medical City. They will participate in ten online sessions, where they will learn about healthy eating and lifestyle improvements. Additionally, they will regularly weigh themselves. Data will be collected before and after the program to assess its impact on weight loss and overall well-being.

By the end of the project, the investigators hope to have developed an effective program that assists Saudi individuals in losing weight and maintaining good health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults within the age range of 18 to 75 years old

• Individuals with a BMI greater than 25 kg/m²

• Proficient in the Arabic language

• Not currently pregnant or breastfeeding

• Not using glucagon-like peptide -1 (GLP-1) or any weight loss medications

• Have not undergone bariatric surgery

• Possess Wi-Fi connectivity at their residence

• Own a smartphone

• Willing to provide consent for participation in 10 educational sessions spanning three months.

Exclusion Criteria:

• Individuals not meeting the inclusion criteria.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Education sessions
Ten 40-minute education sessions appropriate to Saudi people will be developed and will cover essential topics for enhancing diet, lifestyle, and health. Each session comprises four modules, including activities and homework reviewed by a dietitian. Based on the EMPOWER weight loss program developed by the Nakamura lab for the US population, adjustments will be made to align with Saudi preferences, including food choices and cooking methods. Participants will access these materials online.

Locations

Country	Name	City	State
Saudi Arabia	King Abdullah Medical City (KAMC)	Makkah

Sponsors (2)

Lead Sponsor	Collaborator
Asma Yahya	King Abdullah Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program feasibility and acceptability	Participants' views on the program's feasibility and acceptability will be gauged through structured surveys or interviews at the intervention's end.; We'll employ two surveys: Feasibility Survey: this survey developed based on a previous study, examines various aspects like personal gain, program content, and engagement. Participants rate questions on a 1-5 scale and provide open-ended feedback.; Feedback Survey: Participants will rate enjoyment, likelihood of recommendation, perceived benefits, and willingness to pay for services on a 1-5 scale. Open-ended questions will capture additional feedback.	3 months
Secondary	Weight Loss	Change in body weight from baseline to three months.	3 months