Overweight and ObesityNCT06415695
Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations
A study testing Education sessions in people with Overweight and Obesity, run by Asma Yahya at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Education sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Jun 2024to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Possess Wi-Fi connectivity at their residence
- Own a smartphone
- Willing to provide consent for participation in 10 educational sessions spanning three months.
Who cannot join
- Individuals not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Overweight and Obesity
- Being tested
- Education sessions
- Keywords
- Online weight loss program, Feasibility assessment, Dietary education, Sustainable weight loss, Pilot study
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Weight Loss
Change in body weight from baseline to three months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start23 Jun 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asma Yahya
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdullah Medical City
- Responsible party
- Sponsor-investigator, Asma Yahya, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415695
- Sponsor's protocol ID
- IRB23-0344
- Status last verified
- Dec 2024
- First submitted
- 23 Apr 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD won't be shared due to privacy and confidentiality concerns.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Dietary Weight Loss Program to Overcome Obesity and Its Comorbidity Among Arab Populations: Pilot Study
- ClinicalTrials.gov ID
- NCT06415695
- Acronym / sponsor ID
- IRB23-0344
- Conditions
- Overweight and Obesity
- Keywords
- Online weight loss program, Feasibility assessment, Dietary education, Sustainable weight loss, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asma YahyaUniversity, hospital or other
- Collaborators
- King Abdullah Medical City
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| A single-group, pre-post design to evaluate a three-month weight loss intervention in adult. | Experimental | Behavioral: Education sessionsTen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education sessionsTen 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. | Behavioural | A single-group, pre-post design to evaluate a three-month weight loss intervention in adult. |
Primary outcome
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.
1 secondary outcome
Weight Loss
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No. IPD won't be shared due to privacy and confidentiality concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education sessions in people with Overweight and Obesity, run by Asma Yahya at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program feasibility and acceptability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.