MedDataX Logo

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

NCT ID: NCT06415695

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-23

Study Completion Date

2024-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Online weight loss program Feasibility assessment Dietary education Sustainable weight loss Pilot study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The interventional study model for this research involves implementing a single-group, pre-post design to assess the effectiveness of a three-month weight loss intervention among participants with a body mass index (BMI) over 25 kg/m². Participants will engage in ten weekly online sessions covering topics related to dietary and lifestyle improvements. The intervention will be delivered through educational materials specifically tailored for the Saudi population and accessed via an online platform. Participants will also receive a Wi-Fi-enabled scale for self-monitoring of their weight loss progress throughout the intervention period. Data collection will include surveys, dietary assessments, physical measurements, and lifestyle habit assessments at baseline and three months.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Education sessions

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Abdullah Medical City

OTHER_GOV

Sponsor Role collaborator

Asma Yahya

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asma Yahya

Doctoral Student - Main Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Abdullah Medical City (KAMC)

Mecca, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB23-0344

Identifier Type: -

Identifier Source: org_study_id