- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06757556
Effect of Vegetables on Weight Status of University Population
Effect of Consumption of Non-starchy Vegetables on Weight Status of Overweight and Obese University Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity is an increasingly urgent public health challenge in both developed and developing countries. Since 1990, the global prevalence of adult obesity has more than doubled. By 2022, an alarming 2.5 billion adults (aged 18 years and older) were classified as overweight, with 890 million of them living with obesity (WHO, 2023). The World Health Organization (WHO) estimates that one in eight people worldwide now lives with obesity, which is linked to a variety of negative health outcomes, including increased risks for chronic diseases such as diabetes, hypertension, and cardiovascular conditions.
In Pakistan, the situation is equally concerning, with 30% of the adult population being either overweight or obese. More specifically, 21% of adults are classified as overweight, and 9% are considered obese. Non-communicable diseases (NCDs), such as heart disease, stroke, and diabetes, are now responsible for 58% of all deaths in the country. Overweight and obesity are particularly prevalent among young adults, whose sedentary lifestyle and poor dietary habits, including increased consumption of fast food and decreased vegetable intake, contribute significantly to weight gain. University students and staff in Pakistan are also heavily affected, with the prevalence of central obesity reaching 31.4% in males and 46% in females. In fact, 16% of Pakistani females and 30.5% of males have a BMI greater than or equal to 25 kg/m², as per local South Asian BMI cut-off points (Khan et al., 2016).
The WHO expert consultation in 2002 recommended lowering the BMI cut-off points for Asians to better address obesity-related public health concerns in the region, suggesting that a BMI of 23-27.5 kg/m² be classified as overweight, and a BMI of ≥27.5 kg/m² be categorized as obese (WHO, 2004). Given these statistics, there is a pressing need to identify effective, culturally appropriate interventions to combat obesity, particularly among university populations.
One promising intervention is increasing the intake of non-starchy vegetables, which are rich in nutrients and low in calories. WHO guidelines recommend daily consumption of non-starchy vegetables to aid weight management by improving overall diet quality, reducing fat mass, and lowering BMI. Research has shown that increasing vegetable consumption can help reduce body weight and fat mass, particularly in overweight and obese individuals.
This study aims to evaluate the effects of increasing daily non-starchy vegetable consumption on the weight, BMI, and fat mass of overweight and obese individuals in a university setting. A randomized controlled trial (RCT) will be conducted at the University of Veterinary and Animal Sciences (UVAS) in Lahore, Pakistan, involving students, teaching staff, and non-teaching staff who meet the inclusion criteria of a BMI ≥23 kg/m² based on South Asian cut-off points (Mahajan and Batra, 2018). A total of 40 participants will be randomly assigned to one of two groups: an intervention group and a control group, with 20 participants in each group.
The intervention group will receive 2-3 cups (approximately 250g) of WHO-recommended non-starchy vegetables daily for 10 weeks. These vegetables will include options like cucumbers, kale, cauliflower, spinach, cabbage, tomatoes, capsicum, broccoli, and lettuce, all of which have been shown to reduce body weight, BMI, and fat mass by influencing leptin levels (a hormone involved in regulating fat storage and hunger). The control group, on the other hand, will receive dietary guidelines on the recommended daily intake of non-starchy vegetables, but no vegetables will be provided.
Baseline assessments will be conducted during the first week of the study, where participants' weight, BMI, and fat mass will be measured using a weight scale and an InBody 270 body composition analyzer. Dietary counseling will also be provided at this stage, focusing on the benefits of non-starchy vegetables for weight management. From the second week onward, the intervention group will begin receiving their daily servings of vegetables, and the study will continue for 10 weeks.
At the conclusion of the 10-week intervention (week 12), post-assessment measurements will be taken for both the intervention and control groups. In addition to anthropometric measurements, participants in the intervention group will be asked to keep a food diary documenting their daily intake of non-starchy vegetables. This will help assess adherence to the intervention and track how participants incorporate the recommended vegetables into their daily diets.
The data collected will be analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics will be used to present baseline measurements, while paired t-tests will compare changes within groups over the course of the study. Independent t-tests will assess differences between the control and intervention groups. Multiple logistic regression analysis will be employed to examine the relationship between non-starchy vegetable consumption and changes in weight, BMI, and fat mass, controlling for confounding variables such as other dietary factors.
This study seeks to provide valuable insights into the effectiveness of increasing non-starchy vegetable intake in reducing weight, BMI, and fat mass among overweight and obese university populations in Pakistan. The findings could have important implications for public health initiatives aimed at addressing obesity and improving diet quality in university settings, contributing to broader efforts to combat the obesity epidemic in South Asia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qaisar Raza, PhD
- Phone Number: +923002479044
- Email: qaisar.raza@uvas.edu.pk
Study Contact Backup
- Name: Urwah Ashraf Rana, MPhil
- Phone Number: +923374644229
- Email: urwahrana015@gmail.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Qaisar Raza
-
Contact:
- Qaisar Raza, PhD
- Phone Number: +923002479044
- Email: qaisar.raza@uvas.edu.pk
-
Contact:
- Urwah Ashraf Rana, MPhil
- Phone Number: +923374644229
- Email: urwahrana015@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Overweight and obese individuals with BMI 23kg/m^2
- Population of UVAS (students, teaching and non-teaching staff)
Exclusion criteria:
- Normal weight and underweight individuals with BMI <23kg/m^2
- Non-UVAS (University of Veterinary and Animal Sciences) population.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre and post in-body assessment with no vegetable intake 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.
|
|
|
Experimental: Pre and post in-body assessment with vegetable intake intervention.
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. |
Intervention will consist of provision of vegetables (based on WHO criteria of 2-3 servings) to overweight and obese adults fo weight loss purpose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight status (BMI)
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass (Percent body fat)
Time Frame: 12 weeks
|
The investigator will check the percentage of body fat in relation to the total body weight of the participants.
Percentage body fat is the measure of amount of fat in your body compared to your lean body mass (muscle, bone, water etc).
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Qaisar Raza, PhD, UVAS Lahore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Qaisar Raza
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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