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Lifestyle-related ConditionTelehealthNCT05654337

Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia

A study testing Expert health counseling in people with Lifestyle-related Condition, run by The New Model of Care, Hail Health Cluster at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this pragmatic trial is to test the benefit of using dietary advice and health coaching for physical activities for obese and overweight in lowering body weight and making them lead a healthy lifestyle. The advice will be provided by an expert dietician and health coach at the primary health care. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Lifestyle-related Condition
What is being tested?
Expert health counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteSaudi Arabia
Study dates
15 Mar 2023to Nov 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 18-60 with proven obesity and overweight

Who cannot join

  • severely ill or patient with other chronic health conditions

Trial locations and contacts

1 site in 1 country.

Fakhralddin Elfakki, Research Manager at MOC contact

+966530855161

abbasfakhraddin@gmail.com

Marwa Mahmoud Mahdy, CSoC Lead contact

+966508258235

maroo_79@hotmail.com

Saudi Arabia1 site, 1 recruiting
  • New Model of Care at Hail Health Cluster

    Ha'il, 55421

    Fakhralddin A Elfakki, +966535817539, abbasfakhraddin@gmail.com

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia: A Randomized Clustered Trial

The goal of this pragmatic trial is to test the benefit of using dietary advice and health coaching for physical activities for obese and overweight in lowering body weight and making them lead a healthy lifestyle. The advice will be provided by an expert dietician and health coach at the primary health care. The main questions it aims to answer are:

To what extent does the obesity pathway among overweight and obese adults implemented at primary health care Clinics work well in lowering weight? To what extent do the use of dietary advice and coaching for physical activities for obese and overweight implemented at primary health care Clinics work well in achieving a positive lifestyle change? Participants will be asked to participate in the obesity pathway at primary care centres. An expert dietician and health coach will be used to provide a schedule for dietary control and coaching for physical activities.

Read more

Researchers will compare the change in body weight and lifestyle among overweight and obese adults in the intervention versus the control group at the primary care centre.

Adopting a healthy lifestyle, standard weight, healthy dietary habits, plus wise efforts to lowering your body weight is valuable. These need advice from an expert dietician and health coach to prevent the risk of contracting diabetes, heart disease, and cancer.

Read the detailed description

Leadership and a multisectoral approach are the cornerstones in tackling the prevention of non-communicable diseases in Saudi Arabia. A focus should be on physical inactivity, tobacco, and unhealthy diet using effective and cost-effective interventions.

The last updated clinical practice guideline for the non-pharmacological management of overweight and obese Saudi adults strongly suggests lifestyle intervention rather than usual care alone, individualized counselling interventions rather than a generic educational pamphlet, physical activity rather than no physical activity, and physical activity in addition to diet rather than diet alone.

Many countries had implemented taxes on unprocessed sugar or sugar-added foods for reducing their consumption and preventing obesity and other adverse health events. however, no concrete evidence of the effectiveness of the intervention on the ground.

Mobile intervention technologies like pedometers or accelerometers with displays, activity trackers, smartphones, or tablets have a great effect in supporting sustainable health behaviour, increasing physical activity, and preventing the risk of chronic disease.

Research Questions:

  1. To what extent does the obesity pathway intervention among overweight and obese adults implemented at primary health care clinics effective in achieving weight reduction?
  2. To what extent does individualize nurse counselling such as dietary education and physical activity intervention among overweight and obese adults implemented at primary health care clinics effective in achieving a positive lifestyle change?

General objective:

To estimate the effectiveness of the obesity pathway intervention (individualized nurse counselling: dietary education and physical activity) at primary health care clinic in achieving weight reduction and positive lifestyle changes among overweight and obese adults.

Specific Objectives:

Aim 1: To compare the proportion of weight reduction among overweight and obese adults in the intervention versus the control group (routine care) at the Primary Health Care Clinic.

Aim 2: To compare the change in lifestyle among overweight and obese adults in the intervention versus the control group at the primary health care clinic.

Literature Review:

Planning an established clinic-based weight reduction program requires paying attention to different barriers to the retention of patients in the program.

Research Design and Methods:

This is a six months clustered randomized trial that will recruit adults who are obese and overweight to attend a primary health care clinic in Hail city.

Participants (P):

The participants will be adults who are obese and overweight of both genders attending the selected health centres. The participants are expected to be adults aged 18 years and above. Children and young adults will be excluded. In addition, severely ill patients, and patients with mental disorders will be excluded. The participants will be assessed at the start to collect the baseline data about Body Mass Index (BMI) to report eligible participants. At the end of the trial, a similar report on BMI will be obtained for each participant at three and six months after the beginning of the trial. A qualitative assessment report on lifestyle changes i.e. dietary habits and physical activities will also be obtained.

Being tested
Expert health counseling
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expert health counselingOther

    Also called Dietary education, lifestyle change, and physical exercise schedule

    Expert advice on dietary education, lifestyle change, and physical exercise schedule

Study groups in NCT05654337
Study groupRoleWhat they receive
Dietary and physical activity plan and advice on lifestyle changeExperimentalDietary and physical activity schedules and instructed lifestyle change advice provided by a trained health coach and dietary education provided by a trained and licensed dietitian to the obese and overweight at the primary care centre.
Receives: Other: Expert health counseling
Routine care for cases with obesity and overwieghtNo interventionAdults with obesity and overweight attending routine primary care clinics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of obese and overweight who lose 5% of their weight among participants.

    The percentage of obese patients who lose 5% of their weight among participants in the intervention versus the control group (routine care) at the primary care clinic. This will be measured using a scoring checklist at the clinic and a self-based assessment card,

    Measured: 6 month from the start of the study

  2. The percentage of patients who reduced their weight by 5%, and achieved more than 70 % adherence rate

    The percentage of patients who reduced their weight by 5%, and achieved more than 70 % adherence rate to the provided schedule of dietary habits and physical activity in the intervention group vs. the control group

    Measured: 6 month from the start of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start15 Mar 2023
  3. Primary completionOct 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654337
Sponsor's protocol ID
Hail Health Cluster
Acronym
Telehealth
Status last verified
Jul 2024
First submitted
7 Dec 2022
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elfakki FA, Aljamani MY, Mahdy MM, Al Zuhair AA, Altamimi MS, Alshammari SN, Alshammari NM, Aowisy MAA, Alzabni WM. Evaluation of the impact of a family physician-led lifestyle clinic on overweight and obesity: A clustered randomized trial in Hail, Saudi Arabia. J Family Med Prim Care. 2025 May;14(5):2018-2025. doi: 10.4103/jfmpc.jfmpc_1969_24. Epub 2025 May 31.

    PubMed 40547737

Questions about this trial

What is this clinical trial studying?

A study testing Expert health counseling in people with Lifestyle-related Condition, run by The New Model of Care, Hail Health Cluster 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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fakhralddin Elfakki, Research Manager at MOC (+966530855161, abbasfakhraddin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of obese and overweight who lose 5% of their weight among participants. (time frame: 6 month from the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654337, which also lists 1 linked publication.

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 3 Jul 2024.

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