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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
The New Model of Care, Hail Health Cluster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lifestyle-related Condition

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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

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