Effect of Vegetables on Weight Status of University Population

NCT06757556 | Not Yet Recruiting

• 1 other identifier: Qaisar Raza
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity rates have more than doubled globally since 1990, with 2.5 billion overweight adults by 2022, and 890 million of them living with obesity (WHO, 2023). In Pakistan, approximately 30% of adults are overweight or obese, with 21% overweight and 9% obese. Non-communicable diseases now account for 58% of deaths in the country. WHO recommends daily consumption of non-starchy vegetables to aid weight loss and reduce BMI and fat mass, especially for overweight and obese individuals. This randomized controlled trial (RCT) will be conducted at the University of Veterinary and Animal Sciences (UVAS) in Lahore, Pakistan, targeting the university population, including students, teaching, and non-teaching staff with BMI ≥23 kg/m². A total of 40 participants will be recruited, with 20 assigned to the intervention group (receiving 2-3 cups of non-starchy vegetables daily) and 20 to the control group (receiving only dietary guidelines). Weight, BMI, and fat mass will be measured before and after the trial using an InBody 270. The data will be analyzed using SPSS version 25, with paired and independent t-tests to compare changes within and between groups. Multiple logistic regression will examine the relationship between vegetable consumption and changes in weight, BMI, and fat mass. This study aims to assess the impact of daily non-starchy vegetable intake on the weight, BMI, and fat mass of the overweight and obese university population.

Conditions

Obesity Control; Overweight and Obese Adults

Outcome Measures

Primary Outcomes (1)

• Weight status (BMI)

  Intervention consists of provision of vegetables based on WHO criteria of 2-3 servings (250g) for weight loss purposes. the Investigator will calculate the body mass index of participants which is the general indicator of weight status.

  12 weeks

Secondary Outcomes (1)

• Fat mass (Percent body fat)

  12 weeks

Study Arms (2)

Pre and post in-body assessment with no vegetable intake intervention.

NO INTERVENTION

Control group will consist of 20 participants and will be provided with no intervention. Pre assessment including in-body analysis of control group will be done in 1st week of study and post assessment will be done in 12th week of the study.

Pre and post in-body assessment with vegetable intake intervention.

EXPERIMENTAL

Interventional group will consist of 20 participants. Pre assessment will be done in 1st week of study such as In-body analysis and intervention will be provided to these participants for 10 weeks and then post assessment will be done in 12th week after completion of intervention. 2-3 servings (250g) of non-starchy vegetables, as recommended by WHO, will be provided to each participant for 10 weeks.

Other: Non-starchy vegetables will be provided to the participants as an intervention.

Interventions

Non-starchy vegetables will be provided to the participants as an intervention. OTHER

Intervention will consist of provision of vegetables (based on WHO criteria of 2-3 servings) to overweight and obese adults fo weight loss purpose.

Pre and post in-body assessment with vegetable intake intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight and obese individuals with BMI 23kg/m\^2
• Population of UVAS (students, teaching and non-teaching staff)

You may not qualify if:

• Normal weight and underweight individuals with BMI \<23kg/m\^2
• Non-UVAS (University of Veterinary and Animal Sciences) population.

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

Qaisar Raza

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• The information will be shared in the form of thesis on this website

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qaisar Raza, PhD

  UVAS Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qaisar Raza, PhD

CONTACT

+923002479044; qaisar.raza@uvas.edu.pk

Urwah Ashraf Rana, MPhil

CONTACT

+923374644229; urwahrana015@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study as the participants are being informed whether they are in control or interventional group.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Interventional Randomized Controlled Trial.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 3, 2025
• Study Start: February 17, 2025
• Primary Completion: April 17, 2025
• Study Completion: September 8, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD information will be shared by June 2025 and will be available indefinitely.
• Access Criteria: IPD information will be available for researchers and general public through electronic and print sources.

Locations

PA (1)