- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856734
Weight Gain in First-year University Students
The Impact of Living Arrangements, Dietary and Alcohol Intake, Physical Activity, and Stress on Weight Gain in First-year University of Aberdeen Students
Study Overview
Status
Conditions
Detailed Description
The study will be an observational study with four groups including three groups of university student and a group of age-matched volunteers living in the same city that are not attending university as a control:
- University students living at home.
- University students living in private accommodation.
- University students living in the halls of residence.
- Non-university participants living in Aberdeen.
Recruitment will take place over two academic years using flyers sent via email or distributed face-to-face among undergraduate first-year students at the University of Aberdeen (e.g., the Freshers Week), as well as in different public areas, such as supermarkets and shopping centres. If participants agree to participate in this study by signing the consent form, their involvement will last around eight months. This includes three research periods. One at the beginning of the academic year (late September/early October) and then a follow-up after three months (after the Christmas holidays in January), and at eight months (end of the academic year in May). Participants will be asked to come to a designated room at the University of Aberdeen. Each appointment will be in the morning (approx. 15 to 20 minutes for each visit).
During each visit, participants will be provided with further details concerning the study and given time to ask questions.
Measures:
- Anthropometric Measurements will be taken: Body Weight (BW), Body Mass Index (BMI), Sitting Height Ratio (SHR), Waist to Hip Ratio (WHR), Finger Ratio, Body Fat (BF%), and Growth Charts.
- Dietary intake will be examined in two distinct ways. Firstly, self reported questionnaire. Secondly, participants will be asked to complete 3 * 24-hour recalls to assess their consumption of ( protein (g), fat (g), carbohydrate (g), energy (kJ), alcohol (g), total sugars (g), non milk extrinsic sugars (g), fruit (g), vegetable (g), meat (g), processed meat (g), poultry (g), and fish (g) ). They will report two weekdays and one weekend day by using Intake24 online dietary recall system.
- Physical activity will be examined in two ways. Firstly, self reported questionnaire. Secondly, participants will use an ActiGraph GT9X Link accelerometer (placed on the waist) to assess their total physical activity (min), total steps (steps), total awake time (min), and total sleep time (min) during weekdays and weekends. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days except when taking a shower or swimming.
- Stress: will be assessed via self reported questionnaire.
- Socio-demographic characteristics: will be assessed via self reported questionnaire.
At the end of each visit, the researcher will explain how the accelerometer and 24-hour dietary recall will be employed.
After each visit, the researcher will contact the participants to remind them to record their food and beverage consumption and to wear the accelerometer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Scotland
-
Aberdeen, Scotland, United Kingdom, AB24 3FX
- University of Aberdeen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Full-time first-year undergraduate students attending the University of Aberdeen or age-matched non-university participants living in Aberdeen.
- Aged between 17-20 years old.
- Both males and females will be recruited.
Exclusion Criteria:
- Over 20 years old,
- Pregnant/lactating, or taking medication which may affect their weight.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
University students living at home
Group of university students
|
1- Anthropometric Measurements: Body Weight (BW), Body Mass Index (BMI), Sitting Height Ratio (SHR), Waist to Hip Ratio (WHR), Finger Ratio (FR), Body Fat (BF%), and Growth Charts.
(Single measure)
Other Names:
1- Self reported questionnaire.
(Single measure)
1- Self reported questionnaire.
(Single measure)
|
University students living in private accommodation
Group of university students
|
1- Anthropometric Measurements: Body Weight (BW), Body Mass Index (BMI), Sitting Height Ratio (SHR), Waist to Hip Ratio (WHR), Finger Ratio (FR), Body Fat (BF%), and Growth Charts.
(Single measure)
Other Names:
1- Self reported questionnaire.
(Single measure)
1- Self reported questionnaire.
(Single measure)
|
University students living in the halls of residence
Group of university students
|
1- Anthropometric Measurements: Body Weight (BW), Body Mass Index (BMI), Sitting Height Ratio (SHR), Waist to Hip Ratio (WHR), Finger Ratio (FR), Body Fat (BF%), and Growth Charts.
(Single measure)
Other Names:
1- Self reported questionnaire.
(Single measure)
1- Self reported questionnaire.
(Single measure)
|
Non-university participants living in Aberdeen
Group of age-matched volunteers living in the same city
|
1- Anthropometric Measurements: Body Weight (BW), Body Mass Index (BMI), Sitting Height Ratio (SHR), Waist to Hip Ratio (WHR), Finger Ratio (FR), Body Fat (BF%), and Growth Charts.
(Single measure)
Other Names:
1- Self reported questionnaire.
(Single measure)
1- Self reported questionnaire.
(Single measure)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight (BW) from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Weight (kilograms) will be measured using a Bioimpedance (Tanita MC-580 P) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Body Mass Index (BMI) from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Body Mass Index (BMI) will be measured height (Metres) using a Stadiometer and body weight (kilograms) using a Bioimpedance (Tanita MC-580 P).
BMI (kg/m2) will be calculated by dividing weight by height squared to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Waist to Hip Ratio (WHR) from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Waist to Hip Ratio (WHR) is the ratio of waist circumference to the hip circumference will be measured using tape (CM) .
WHR will be calculated as WC divided by HC to assess percent change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Body Fat (BF%) from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Body Fat (BF%) will be measured by Bioimpedance (Tanita MC-580 P) to assess percent change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Sitting Height Ratio (SHR) from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Sitting Height Ratio (SHR) will measure participants' sitting height on a standard chair using Stadiometer (Metres).
SHR will be calculated as sitting height (SH) divided by total height to assess percent change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Growth Charts from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Growth Charts will be used to calculate the weight for age percentile, and this done by calculator using this website (the Center for Disease Center (CDC) children charts for 2-20 year olds).
Weight for age percentile will be calculated by entering (gender, birthday, weight, and measurement date) to assess percent change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Finger Ratio from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Finger Ratio will be measured using Vernier Caliper.
I will measure the length of participant's index finger 2D of right hand from crease to tip.
Then do the same for the ring finger 4D.
Finger Ratio will be calculated as index finger 2D /ring finger 4D to assess percent change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Protein Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Protein intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for protein intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Fat Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Fat intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for fat intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Carbohydrate Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Carbohydrate intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for carbohydrates intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Energy Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Energy intake (kJ) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for energy intake (kJ) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Alcohol Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Alcohol intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for alcohol intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Sugars Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Total sugars intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for total sugars intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Non-milk Extrinsic Sugars Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Non-milk extrinsic sugars intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for non-milk extrinsic sugars intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Fruit Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Fruit intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for fruit intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Vegetable Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Vegetable intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for vegetable (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Meat Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
meat intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for meat intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Processed Meat Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Processed meat intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for processed meat intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Poultry Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Poultry intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for poultry intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Fish Intake using intake24 from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete 3 * 24-hour recalls recording.
Fish intake (g) will be calculated as follows: day 1= sum, day 2= sum, and day 3=sum, after that I will calculate the average of the three days for fish intake (g) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Dietary Intake using questionnaire from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete a questionnaire.
It includes six multiple-choice questions to evaluate dietary behaviours.
I have categorical data with repeated measures, so I will use non parametric analysis with repeated measures to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Physical Activity on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total physical activity (min) on weekdays (day 1= sum, day 2= sum, day 3=sum, and day 4= sum after that the average of four days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Physical Activity on Weekends using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total physical activity (min) on weekends (day 1 = sum and day 2 = sum after that the average of two days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Steps on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total steps (steps) on weekdays (day 1= sum, day 2= sum, day 3=sum, and day 4= sum after that the average of four days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Steps on Weekends using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total steps (steps) on weekends (day 1 = sum and day 2 = sum after that the average of two days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Awake Time on weekdays using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total awake time (min) on weekdays (day 1= sum, day 2= sum, day 3=sum, and day 4= sum after that the average of four days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Awake Time on Weekends using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total awake time (min) on weekends (day 1 = sum and day 2 = sum after that the average of two days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Sleep on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total sleep time (min) on weekdays (day 1= sum, day 2= sum, day 3=sum, and day 4= sum after that the average of four days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Total Sleep on Weekends using ActiGraph from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days.
I will collected total sleep time (min) on weekends (day 1 = sum and day 2 = sum after that the average of two days will be collected) to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Physical Activity using questionnaire from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Participants will be asked to complete a questionnaire that will evaluate physical activity.
It includes six multiple-choice questions.
I have categorical data with repeated measures, so I will use non parametric analysis with repeated measures to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Stress using questionnaire from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Stress will be assessed by employing a questionnaire which evaluates stress levels in the students.
It includes four multiple-choice questions.
I have categorical data with repeated measures, so I will use non parametric analysis with repeated measures to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Change in Socio-Demographic Characteristics using questionnaire from baseline to follow-up after three months and at eight months.
Time Frame: Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Socio-demographic characteristics will be assessed by employing a questionnaire.
I have categorical data with repeated measures, so I will use non parametric analysis with repeated measures to assess change from baseline to follow-up after three months and at eight months.
|
Baseline at the beginning of the academic year, then a follow-up after three months, and at eight months (end of the academic year ).
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBSEC /09/2022/Sept
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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