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

NCT05654337 | Recruiting

• 1 other identifier: Hail Health Cluster
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lifestyle-related Condition

Outcome Measures

Primary Outcomes (2)

• 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,

  6 month from the start of the study

• 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

  6 month from the start of the study

Study Arms (2)

Dietary and physical activity plan and advice on lifestyle change

EXPERIMENTAL

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

Routine care for cases with obesity and overwieght

NO INTERVENTION

Adults with obesity and overweight attending routine primary care clinics

Interventions

Expert health counseling OTHER

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

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

Dietary and physical activity plan and advice on lifestyle change

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-60 with proven obesity and overweight

You may not qualify if:

• severely ill or patient with other chronic health conditions

Sponsors & Collaborators

• The New Model of Care, Hail Health Cluster: lead
• Health Holding Company, Hail Health Cluster, Saudi Arabia: collaborator

Study Sites (1)

New Model of Care at Hail Health Cluster

Hail, 55421, Saudi Arabia

RECRUITING

Related Publications (1)

• 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.

  PMID: 40547737 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Meshari Aljamani, MOC Lead

  Hail Health Cluster

  STUDY CHAIR

• Sultan N AlShammary, KSS Hospital Director

  New Model of Care, Hail Health Cluser

  STUDY DIRECTOR

• Mohammad S Altamimi, Data Quality Manager at HHC

  New Model of Care, Hail Health Cluster

  STUDY DIRECTOR

• Adel A Al Zuhair, Model of Care Project Manager

  New Model of Care, Hail Health Cluster

  STUDY DIRECTOR

Central Study Contacts

Fakhralddin Elfakki, Research Manager at MOC

CONTACT

+966530855161; abbasfakhraddin@gmail.com

Marwa Mahmoud Mahdy, CSoC Lead

CONTACT

+966508258235; maroo_79@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: March 15, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)