## Protocol Section
### Identification Module
**NCT ID:** NCT06415695

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

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

#### Organization Study ID Info
**ID:** IRB23-0344
#### Organization
**Class:** OTHER
**Full Name:** University of Illinois at Urbana-Champaign
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** King Abdullah Medical City

#### Lead Sponsor

**Class:** OTHER

**Name:** Asma Yahya

#### Responsible Party

**Investigator Affiliation:** University of Illinois at Urbana-Champaign

**Investigator Full Name:** Asma Yahya

**Investigator Title:** Doctoral Student - Main Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Overweight and Obesity

**Keywords:**

- Online weight loss program

- Feasibility assessment

- Dietary education

- Sustainable weight loss

- Pilot study

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Behavioral: Education sessions

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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.

**Name:** Education sessions

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Program feasibility and acceptability

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Change in body weight from baseline to three months.

**Measure:** Weight Loss

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yahya2@illinois.edu

**Name:** Asma M Yahya, Master

**Phone:** 2177224045

**Role:** CONTACT

**Contact 2:**

**Email:** asmaa.m.shathli@hotmail.com

**Name:** Asma Yahya

**Phone:** 2177224045

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Makkah

**Contacts:**

***Contact 1:***

- **Email:** irb@kamc.med.sa

- **Name:** Dr. Osama Shams

- **Phone:** 012 5549999

- **Role:** CONTACT

***Contact 2:***

- **Name:** Midad Ali, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Saudi Arabia

**Facility:** King Abdullah Medical City (KAMC)

**Zip:** 22555

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-31
