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

NCT06415695 | Completed

• 1 other identifier: IRB23-0344
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weight Loss

  3 months

Study Arms (1)

A single-group, pre-post design to evaluate a three-month weight loss intervention in adult.

EXPERIMENTAL

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

Interventions

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.

A single-group, pre-post design to evaluate a three-month weight loss intervention in adult.

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 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.

Sponsors & Collaborators

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

Study Sites (1)

King Abdullah Medical City (KAMC)

Mecca, 22555, Saudi Arabia

Location

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 Design

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

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 16, 2024
• Study Start: June 23, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)