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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lifestyle-related Condition
• Intervention / Treatment: Other: Expert health counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Mahmoud Mahdy, CSoC Lead; Phone Number: +966508258235; Email: maroo_79@hotmail.com
• Study Contact Backup: Name: Fakhralddin Elfakki, Research Manager at MOC; Phone Number: +966530855161; Email: abbasfakhraddin@gmail.com

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 55421
    • Recruiting
    • New Model of Care at Hail Health Cluster
    • Contact: Fakhralddin A Elfakki; Phone Number: +966535817539; Email: abbasfakhraddin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18-60 with proven obesity and overweight

Exclusion Criteria:

• severely ill or patient with other chronic health conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Expert advice on dietary education, lifestyle change, and physical exercise schedule; Other Names: Dietary education, lifestyle change, and physical exercise schedule
No Intervention: Routine care for cases with obesity and overwieght; Adults with obesity and overweight attending routine primary care clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The New Model of Care, Hail Health Cluster
• Collaborators: Health Holding Company, Hail Health Cluster, Saudi Arabia
• Investigators: Study Chair: Meshari Aljamani, MOC Lead, Hail Health Cluster; Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: Hail Health Cluster

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No