NCT06150248

Brief Summary

According to the World Health Organization (WHO), Saudi Arabia has seen a more astonishing rise in obesity. Young females have a considerable prevalence of unhealthy dietary practices and lack of knowledge about healthy and energy-dense foods. Additionally, in Saudi Arabia, the levels of physical inactivity ranged from about one-third to as high as 70% of the population. The current study aims to determine the effects of combined health education and motivational message intervention on promoting healthy lifestyles and body composition markers for undergraduate female students who suffer from obesity at Northern Border University in the Kingdom of Saudi Arabia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

November 20, 2023

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 1. Improve Knowledge, Attitude and Practice of Obesity

    The knowledge, attitude, and practice of obesity will be measured using a self-report instrument knowledge, attitudes, and practices questionnaire (KAPQ) modified by Laar et al. (2020). The questionnaire will consist of close-ended questions divided into three sections: The knowledge section will cover participants' understanding of obesity, its causes, consequences, and prevention strategies. The attitudes section will capture participants' feelings and opinions towards overweight obesity. Some of the items under this section will include how participants feel about their body shape, weight, and diet. The last section will capture participants' practices related to obesity, including the frequency of consumption of fast foods, sweets, refined carbohydrate foods, vegetables, and fruits.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

  • 2. Change the Body mass index (BMI)

    The Body mass index (BMI) will be report in kg/m\^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared). Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg. SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm. Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity). If the BMI is less than 18.5, it falls within the underweight range. If the BMI is 18.5 to \<25, it falls within the healthy weight range. If the BMI is 25.0 to \<30, it falls within the overweight range. If the BMI is 30.0 or higher, it falls within the obesity range.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

Secondary Outcomes (4)

  • 3. Improve the Physical Activity.

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

  • 4. Change Dietary Intake, Dietary Quality, Diet and Eating Behavioural

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

  • 5. Improve Disordered Eating

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

  • 6. Change Sedentary Activity

    [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post-intervention)]]

Study Arms (2)

Intervention group

OTHER

Intervention group: Participants assigned to the intervention group will receive educational intervention program to improve their knowledge and promote lifestyle adherence in terms of healthy diet behaviour and physical activity among the undergraduate students. This program will include educational booklets and educational classes include six weeks of in-person education sessions and six weeks of social media messaging. The course will include six weekly teaching units (lectures and group discussions, 45-60 minutes each): Topic 1: To understand the causes and prevention strategies for overweight and obesity. Topic 2: To understand food based approaches to reduce or prevent overweight and obesity. Topic 3: To understand the importance of regular physical activity. Topic 4: To demonstrate how snacking can be a healthy habit. Topic 5: To learn how to read and interpret food labels. Topic 6: To understand how to prepare healthy meals.

Other: Education Intervention

Control group: No Intervention

OTHER

Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine).

Other: No intervention

Interventions

This intervention is based on the Social Cognitive Theory (SCT) and The Health Belief Model (HBM) to improve knowledge and promote lifestyle adherence in terms of healthy diet behaviour and physical activity among the undergraduate students. This program will include educational booklets and educational classes include six weeks of in-person education sessions and six weeks of social media messaging. The course will include six weekly teaching units (lectures and group discussions, 45-60 minutes each): Topic 1: To understand the causes and prevention strategies for overweight and obesity. Topic 2: To understand food based approaches to reduce or prevent overweight and obesity. Topic 3: To understand the importance of regular physical activity. Topic 4: To demonstrate how snacking can be a healthy habit. Topic 5: To learn how to read and interpret food labels. Topic 6: To understand how to prepare healthy meals.

Intervention group

They will have their regular curriculums and normal physical activity routine.

Control group: No Intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly Female undergraduate students.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female undergraduate students.
  • Saudi students.
  • Aged between 18-24 years.
  • Categorized with a BMI greater than 25.

You may not qualify if:

  • Pregnant students
  • Students with diseases on treatment such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases.
  • Students with any medical condition who not allowed to do physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geeta Appannah

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

ObesitySedentary Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Geeta Appannah, PhD

    Department of Nutrition , Faculty of Medicine and Health Sciences, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia

    STUDY CHAIR

Central Study Contacts

HANAN ALZAREA, Master

CONTACT

Geeta Appannah, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Cluster randomized controlled trial (RCT) design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 29, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations