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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05856734
Other study ID # SBSEC /09/2022/Sept
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2022
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The transition to university from secondary school comes with many changes to living arrangements, dietary and alcohol intake, physical activity, and stress. The purpose of this study is to explore weight gain in new university students in the UK under the 'Freshman15' phenomenon. This phenomenon is an expression commonly used in the United States and Canada to describe a weight gain of 15 lbs (6.8 kg) in students who transition from secondary school to university life. The research will assess to investigate the impact of lifestyle factors that predict students' weight gain during their first year at the University of Aberdeen. The study specifically focuses on how these factors vary based on their living arrangement. Also, the change in lifestyle will be explored in relation to age-matched individuals not-attending university.


Description:

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: 1. University students living at home. 2. University students living in private accommodation. 3. University students living in the halls of residence. 4. 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: 1. 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 Weight-for- Age Growth Charts. 2. 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. 3. 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 physical activity (h), Activity intensity level (min), total awake duration (min), and total sleep duration (min) during weekdays and weekends. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days except when taking a shower or swimming. 4. Stress: will be assessed via self reported questionnaire. 5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Weight and body composition change
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 Weight-for-age growth charts. (Single measure)
Behavioral:
Change in dietary intake
24-hour recalls using Intake24 (online survey) over 3-day. Self reported questionnaire. (Single measure)
Device:
Change in physical activity
ActiGraph GT9X Link accelerometer over 7-day. Self reported questionnaire. (Single measure)
Behavioral:
Change in stress
1- Self reported questionnaire. (Single measure)
Change in socio-demographic characteristics
1- Self reported questionnaire. (Single measure)
Device:
Change in sleep
ActiGraph GT9X Link accelerometer over 7-day. (Single measure)

Locations

Country Name City State
United Kingdom University of Aberdeen Aberdeen Scotland

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen University of Jazan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Weight (BW) from baseline to follow-up after three months and at eight months. 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 ).
Primary Change in Body Mass Index (BMI) from baseline to follow-up after three months and at eight months. 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 ).
Primary Change in Waist to Hip Ratio (WHR) from baseline to follow-up after three months and at eight months. 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 ).
Primary Change in Body Fat (BF%) from baseline to follow-up after three months and at eight months. 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 ).
Primary Change in Sitting Height Ratio (SHR) from baseline to follow-up after three months and at eight months. 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 ).
Primary Change in Weight-for- Age Growth Charts from baseline to follow-up after three months and at eight months. Weight-for- Age 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 ).
Primary Change in Finger Ratio from baseline to follow-up after three months and at eight months. 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 Change in Protein Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Fat Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Carbohydrate Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Energy Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Alcohol Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Total Sugars Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Non-milk Extrinsic Sugars Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Fruit Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Vegetable Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Meat Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Processed Meat Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Poultry Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Fish Intake using intake24 from baseline to follow-up after three months and at eight months. 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 ).
Secondary Change in Dietary Intake using questionnaire from baseline to follow-up after three months and at eight months. 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.
The first question require participants to report their daily calorie intake to maintain their current weight or to lose weight (such as yes, I have been for six months or longer/yes, I have but for less than six months/no, but I intend to in the next 30 days/no, but I intend to in the next six months/no, and I do not intend to in the next six months) etc.
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 Change in Physical Activity on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. To calculate hourly physical activity, the vector magnitude (VM) data for each minute within an hour (specifically, from 0:00 to 0:59 etc.) will summed. Subsequently, the average hourly physical activity (PA) will computed by considering the days when the monitor was worn. 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 Change in Physical Activity on Weekends using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. To calculate hourly physical activity, the vector magnitude (VM) data for each minute within an hour (specifically, from 0:00 to 0:59 etc.) will summed. Subsequently, the average hourly physical activity (PA) will computed by considering the days when the monitor was worn. 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 Change in activity intensities on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months. To calculate the average activity counts per minute and the percentages of time spent in different activity intensities (sedentary, light, moderate, vigorous, and very vigorous), Actilife software version 6.13.4 will used. The analysis incorporate the use of the Freedson Adult 1998 cut-off points with an epoch length of 60 seconds. 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 Change in Total Awake Duration on weekdays using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. I will collected total awake duration (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 ).
Secondary Change in Total Awake Duration on Weekends using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. I will collected total awake duration (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 ).
Secondary Change in Total Sleep Duration on Weekdays using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. I will collected total sleep duration (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 ).
Secondary Change in Total Sleep Duration on Weekends using ActiGraph from baseline to follow-up after three months and at eight months. Participants will wear ActiGraph GT9X Link accelerometers for seven consecutive days. I will collected total sleep duration (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 ).
Secondary Change in Physical Activity using questionnaire from baseline to follow-up after three months and at eight months. 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.
For example, physical activity will assessed by asked participants to report which best describes their level of physical activity (e.g., I am inactive and don't plan on starting in the next six months/ I am inactive but I'm thinking about starting in the next six months/ I do a bit of physical activity, but not a lot/ I have been doing physical activity for six months/ I have been doing physical activity for more than six months) etc.
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 Change in Stress using questionnaire from baseline to follow-up after three months and at eight months. 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.
For example, the first question will asked participants to answer with (Yes /No) "Are you comfortable at their present level of stress?". The second question will, "How often do you feel stress?" participants provided with these options to choose from (e.g., (always/sometimes/rarely/never) etc..
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 Change in Socio-Demographic Characteristics using questionnaire from baseline to follow-up after three months and at eight months. 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 ).
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