Clinical trial NCT05654337: Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia
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
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle-related Condition
Lead sponsor: The New Model of Care, Hail Health Cluster
Sponsor class: OTHER_GOV
Collaborators: name: Health Holding Company, Hail Health Cluster, Saudi Arabia
First posted: 2022-12-16
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-60 with proven obesity and overweight

Exclusion Criteria:

* severely ill or patient with other chronic health conditions

Primary outcomes:
measure: The percentage of obese and overweight who lose 5% of their weight among participants.
timeFrame: 6 month from the start of the study
measure: The percentage of patients who reduced their weight by 5%, and achieved more than 70 % adherence rate
timeFrame: 6 month from the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: New Model of Care at Hail Health Cluster
Study officials:
affiliation: Hail Health Cluster
name: Meshari Aljamani, MOC Lead
role: STUDY_CHAIR
affiliation: New Model of Care, Hail Health Cluser
name: Sultan N AlShammary, KSS Hospital Director
role: STUDY_DIRECTOR
affiliation: New Model of Care, Hail Health Cluster
name: Mohammad S Altamimi, Data Quality Manager at HHC
role: STUDY_DIRECTOR
affiliation: New Model of Care, Hail Health Cluster
name: Adel A Al Zuhair, Model of Care Project Manager
role: STUDY_DIRECTOR
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