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RecruitingNCT05654337TelehealthUpdated Jul 3, 2024

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

An interventional study of Expert health counseling in Lifestyle-related Condition, sponsored by The New Model of Care, Hail Health Cluster. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by The New Model of Care, Hail Health Cluster · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Lifestyle-related Condition

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's planned enrollment of 440 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

The New Model of Care, Hail Health Cluster is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults aged 18-60 with proven obesity and overweight

Exclusion criteria

Exclusion Criteria:

  • severely ill or patient with other chronic health conditions
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Dietary and physical activity plan and advice on lifestyle change

    Dietary 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.

    Other: Expert health counseling

  • No intervention
    Routine care for cases with obesity and overwieght

    Adults with obesity and overweight attending routine primary care clinics

Interventions

  • OtherExpert health counseling

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

    Also known as: Dietary education, lifestyle change, and physical exercise schedule

06

What researchers measure

Primary outcomes

  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,

    Time frame: 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

    Time frame: 6 month from the start of the study

07

Study locations

1 of 1 sites recruiting
  • New Model of Care at Hail Health Cluster
    Hail, 55421, Saudi Arabia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05654337
Lead sponsor
The New Model of Care, Hail Health Cluster
Collaborators
Health Holding Company, Hail Health Cluster, Saudi Arabia
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Mar 15, 2023
Primary completion
Oct 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Jul 3, 2024

Study contacts

Fakhralddin Elfakki, Research Manager at MOC
Contact
abbasfakhraddin@gmail.com
+966530855161
Marwa Mahmoud Mahdy, CSoC Lead
Contact
maroo_79@hotmail.com
+966508258235
Meshari Aljamani, MOC Lead
study chair · Hail Health Cluster
Sultan N AlShammary, KSS Hospital Director
study director · New Model of Care, Hail Health Cluser
Mohammad S Altamimi, Data Quality Manager at HHC
study director · New Model of Care, Hail Health Cluster
Adel A Al Zuhair, Model of Care Project Manager
study director · New Model of Care, Hail Health Cluster

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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