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Completed

NCT Number: NCT06415695

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah Medical City (KAMC)

Mecca, 22555, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education sessions

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight Loss

    Time frame: 3 months

    Change in body weight from baseline to three months.

Sponsors and collaborators

Lead sponsor

Asma Yahya

Other

Collaborators

  • King Abdullah Medical City

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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