Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia (Telehealth)
Primary Purpose
Lifestyle-related Condition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expert health counseling
Sponsored by

About this trial
This is an interventional other trial for Lifestyle-related Condition
Eligibility Criteria
Inclusion Criteria: Adults aged 18-60 with proven obesity and overweight Exclusion Criteria: severely ill or patient with other chronic health conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary and physical activity plan and advice on lifestyle change
Routine care for cases with obesity and overwieght
Arm Description
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.
Adults with obesity and overweight attending routine primary care clinics
Outcomes
Primary Outcome Measures
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,
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05654337
First Posted
December 7, 2022
Last Updated
December 27, 2022
Sponsor
The New Model of Care, Hail Health Cluster
Collaborators
Health Holding Company, Hail Health Cluster, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT05654337
Brief Title
Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia
Acronym
Telehealth
Official Title
Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia: A Randomized Clustered Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The New Model of Care, Hail Health Cluster
Collaborators
Health Holding Company, Hail Health Cluster, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
To what extent does the obesity pathway intervention among overweight and obese adults implemented at primary health care clinics effective in achieving weight reduction?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle-related Condition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary and physical activity plan and advice on lifestyle change
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care for cases with obesity and overwieght
Arm Type
No Intervention
Arm Description
Adults with obesity and overweight attending routine primary care clinics
Intervention Type
Other
Intervention Name(s)
Expert health counseling
Other Intervention Name(s)
Dietary education, lifestyle change, and physical exercise schedule
Intervention Description
Expert advice on dietary education, lifestyle change, and physical exercise schedule
Primary Outcome Measure Information:
Title
The percentage of obese and overweight who lose 5% of their weight among participants.
Description
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
Title
The percentage of patients who reduced their weight by 5%, and achieved more than 70 % adherence rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults aged 18-60 with proven obesity and overweight
Exclusion Criteria:
severely ill or patient with other chronic health conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fakhralddin Elfakki, Researcher at MOC
Phone
+966530855161
Email
abbasfakhraddin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Mahmoud Mahdy, CSoC Lead
Phone
+966508258235
Email
maroo_79@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalil Alshammari, VIP Chief MO
Organizational Affiliation
Hail Health Cluster
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fakhralddin Elfakki, Researcher at MOC
Organizational Affiliation
New Model of Care, Hail Health Cluser
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meshari Aljamani, MOC Lead
Organizational Affiliation
New Model of Care, Hail Health Cluster
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia
We'll reach out to this number within 24 hrs