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

May 13, 2024 updated by: Asma Yahya

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Saudi Arabia
      • Makkah, Saudi Arabia, 22555
        • King Abdullah Medical City (KAMC)
        • Contact:
        • Principal Investigator:
          • Midad Ali, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A single-group, pre-post design to evaluate a three-month weight loss intervention in adult.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program feasibility and acceptability
Time Frame: 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 3 months
Change in body weight from baseline to three months.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asma Yahya

Collaborators

King Abdullah Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD won't be shared due to privacy and confidentiality concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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