ObesityNCT05856734
Weight Gain in First-year University Students
An observational study of Obesity, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 17 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight and body composition change, Change in dietary intake and Change in physical activity
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: About 80 participants will be either full-time first-year undergraduate students attending the University of Aberdeen or age-matched non-university participants living in Aberdeen. Participants will be aged between 17-20 years. Both males and females will be recruited. Participants for the University categories will be recruited from across the range of programmes and living in (1) halls of residence (2) private accommodation (3) remaining at the family home. They may be UK or international students. The non-university volunteers may live in the family home or out of the home but must be recent high school graduates (within two years of graduating)
Who may be able to join
- 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.
Who cannot join
- Over 20 years old,
- Pregnant/lactating, or taking medication which may affect their weight.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Scotland, AB24 3FX
About this study
Official title: Explore How Living Arrangements Impact Dietary Intake, Physical Activity, Sleep Patterns and Stress Levels, Which Contribute to Weight Gain in First-year Undergraduate Students at University of Aberdeen
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 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. First aim: 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. Second aim: To examine changes in weight, living arrangements, dietary intake, physical activity, sleep and stress after one year at university with previous participation students who moved to their second year to understand the influence that university life has on these trends compared to their first visit at the beginning of their first year at the university.
Read the detailed description
Detailed Description:
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.
Aim1 "Transition to university study" During each academic year, I will conduct three visits with participants: At the beginning of the academic year in late September/October (Visit 1), after 3 months in January (Visit 2), and after 8 months at the end of the academic year in mid-April/May (Visit 3).
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.
Aim 2 "Follow-up study" I will conduct one visit with previous participating students in the study 1: in September/October year, after one year at the university (Visit 4).
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 30 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 Weight-for- Age 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 physical activity (h), Activity intensity level (min).
- Sleep patterns will be examined by ActiGraph GT9X Link accelerometer (placed on the waist) to assess their total awake duration (min), total sleep duration(min), bedtime (hh:mm), and wake time (hh:mm).
- Stress: will be assessed via self reported questionnaire.
- Socio-demographic characteristics: will be assessed via self reported questionnaire.
- Changes in lifestyle behaviours: will be assessed via self reported questionnaire.
- Conditions
- Obesity
- Being tested
- Weight and body composition change, Change in dietary intake, Change in physical activity, Change in stress, Change in socio-demographic characteristics
- Keywords
- freshman 15, weight gain, university students, first-year university students, stress, living arrangement, physical activity, dietary intake, alcohol consumption, weight change, sleep
- Medical subject headings
- Obesity, Weight Gain, Motor Activity, Alcohol Drinking, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight and body composition changeDevice
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)
Change in dietary intakeBehavioural
- 24-hour recalls using Intake24 (online survey) over 3-day.
- Self reported questionnaire. (Single measure)
Change in physical activityDevice
Also called Behavioral
- ActiGraph GT9X Link accelerometer over 7-day.
- Self reported questionnaire. (Single measure)
Change in stressBehavioural
1- Self reported questionnaire. (Single measure)
Change in socio-demographic characteristicsBehavioural
1- Self reported questionnaire. (Single measure)
Change in sleepDevice
ActiGraph GT9X Link accelerometer over 7-day. (Single measure)
| Study group | Role | What they receive |
|---|---|---|
| University students living at home | Group of university students Receives: Device: Weight and body composition change; Behavioral: Change in dietary intake; Device: Change in physical activity; Behavioral: Change in stress; Behavioral: Change in socio-demographic characteristics; Device: Change in sleep | |
| University students living in private accommodation | Group of university students Receives: Device: Weight and body composition change; Behavioral: Change in dietary intake; Device: Change in physical activity; Behavioral: Change in stress; Behavioral: Change in socio-demographic characteristics; Device: Change in sleep | |
| University students living in the halls of residence | Group of university students Receives: Device: Weight and body composition change; Behavioral: Change in dietary intake; Device: Change in physical activity; Behavioral: Change in stress; Behavioral: Change in socio-demographic characteristics; Device: Change in sleep | |
| Non-university participants living in Aberdeen | Group of age-matched volunteers living in the same city Receives: Device: Weight and body composition change; Behavioral: Change in dietary intake; Device: Change in physical activity; Behavioral: Change in stress; Behavioral: Change in socio-demographic characteristics; Device: Change in sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (BW)
Weight (kilograms) will be measured using a Bioimpedance (Tanita MC-580 P).
Measured: Baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Body Mass Index (BMI)
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.
Measured: Baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Waist to Hip Ratio (WHR)
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Body Fat (BF%)
Body Fat (BF%) will be measured by Bioimpedance (Tanita MC-580 P).
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Weight-for- Age Growth Charts
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).
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Finger Ratio
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Secondary outcomes (28)
Change in Protein Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fat Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Carbohydrate Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Energy Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Alcohol Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sugars Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Non-milk Extrinsic Sugars Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fruit Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Vegetable Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Meat Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Processed Meat Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Poultry Intake using intake24
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fish Intake using intake24
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Dietary Intake using questionnaire
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.
Measured: 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 on Weekdays using ActiGraph
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Physical Activity on Weekends using ActiGraph.
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in activity intensities using ActiGraph
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Awake Duration on weekdays using ActiGraph
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Awake Duration on Weekends using ActiGraph
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sleep Duration on Weekdays using ActiGraph
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sleep Duration on Weekends using ActiGraph
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)
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Bedtime on Weekdays using ActiGraph
Bedtime will determine by identifying sudden periods of decreased activity levels which will dropped to zero and remained at that level for at least 5 consecutive epochs. To gain a metric variable, hours will count from 0 to 24, and hours after midnight will be counted as 25 (for 1:00), 26 (for 2:00), and so forth, which will then converted to decimal form; for instance, a bedtime of 21:30 will code as 9.50. The average bedtime will be analysed in hours and minutes (hh:mm) format.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Bedtime on Weekends using ActiGraph
Bedtime will determine by identifying sudden periods of decreased activity levels which will dropped to zero and remained at that level for at least 5 consecutive epochs. To gain a metric variable, hours will count from 0 to 24, and hours after midnight will be counted as 25 (for 1:00), 26 (for 2:00), and so forth, which will then converted to decimal form; for instance, a bedtime of 21:30 will code as 9.50. The average bedtime will be analysed in hours and minutes (hh:mm) format.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Wake Time on Weekdays using ActiGraph
Wake time will identify by finding the first epoch of sustained high activity (over 10 activity counts) after a period of at least five 30-second epochs with less than 10 activity counts. To gain a metric variable, hours will count from 0 to 24, and hours after midnight will count as 25 (for 1:00), 26 (for 2:00), and so forth, which will then converted to decimal form; for instance, a wake time of 07:39 will code as 7.65. The average wake time will be analysed in hours and minutes (hh:mm) format.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Wake Time on Weekends using ActiGraph
Wake time will identify by finding the first epoch of sustained high activity (over 10 activity counts) after a period of at least five 30-second epochs with less than 10 activity counts. To gain a metric variable, hours will count from 0 to 24, and hours after midnight will count as 25 (for 1:00), 26 (for 2:00), and so forth, which will then converted to decimal form; for instance, a wake time of 07:39 will code as 7.65. The average wake time will be analysed in hours and minutes (hh:mm) format.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Physical Activity using questionnaire.
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.
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Stress using questionnaire
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..
Measured: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in lifestyle behaviours using questionnaire
lifestyle behaviours will be assessed by employing a questionnaire which evaluates changes in lifestyle behaviours. It includes eleven multiple-choice questions. I have categorical data with repeated measures, so I will use non parametric analysis with repeated measures to assess change after one year at university.
for example, the first question will asked participants to answer with (Yes /No) "Do you still live in the same place?".
Question 2. "Living Arrangement" (Home with family/Private accommodation/Halls of residence)3 Question 3. " Do you believe your eating habits have changed since the start of university?" (Yes/ No) etc.
Measured: After one year at university
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start15 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jazan
- Responsible party
- Principal investigator, Ferdous Alharbi, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856734
- Sponsor's protocol ID
- SBSEC /09/2022/Sept
- Status last verified
- Sep 2024
- First submitted
- 1 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore How Living Arrangements Impact Dietary Intake, Physical Activity, Sleep Patterns and Stress Levels, Which Contribute to Weight Gain in First-year Undergraduate Students at University of Aberdeen
- ClinicalTrials.gov ID
- NCT05856734
- Acronym / sponsor ID
- SBSEC /09/2022/Sept
- Conditions
- Obesity
- Keywords
- freshman 15, weight gain, university students, first-year university students, stress, living arrangement, physical activity, dietary intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- University of Jazan
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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. First aim: 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. Second aim: To examine changes in weight, living arrangements, dietary intake, physical activity, sleep and stress after one year at university with previous participation students who moved to their second year to understand the influence that university life has on these trends compared to their first visit at the beginning of their first year at the university.
Detailed description
Detailed Description:
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.
Aim1 "Transition to university study" During each academic year, I will conduct three visits with participants: At the beginning of the academic year in late September/October (Visit 1), after 3 months in January (Visit 2), and after 8 months at the end of the academic year in mid-April/May (Visit 3).
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.
Aim 2 "Follow-up study" I will conduct one visit with previous participating students in the study 1: in September/October year, after one year at the university (Visit 4).
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 30 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 Weight-for- Age 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 physical activity (h), Activity intensity level (min).
- Sleep patterns will be examined by ActiGraph GT9X Link accelerometer (placed on the waist) to assess their total awake duration (min), total sleep duration(min), bedtime (hh:mm), and wake time (hh:mm).
- Stress: will be assessed via self reported questionnaire.
- Socio-demographic characteristics: will be assessed via self reported questionnaire.
- Changes in lifestyle behaviours: will be assessed via self reported questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| University students living at home | – | Device: Weight and body composition change, Behavioral: Change in dietary intake, Device: Change in physical activity, Behavioral: Change in stress, Behavioral: Change in socio-demographic characteristics, Device: Change in sleepGroup of university students |
| University students living in private accommodation | – | Device: Weight and body composition change, Behavioral: Change in dietary intake, Device: Change in physical activity, Behavioral: Change in stress, Behavioral: Change in socio-demographic characteristics, Device: Change in sleepGroup of university students |
| University students living in the halls of residence | – | Device: Weight and body composition change, Behavioral: Change in dietary intake, Device: Change in physical activity, Behavioral: Change in stress, Behavioral: Change in socio-demographic characteristics, Device: Change in sleepGroup of university students |
| Non-university participants living in Aberdeen | – | Device: Weight and body composition change, Behavioral: Change in dietary intake, Device: Change in physical activity, Behavioral: Change in stress, Behavioral: Change in socio-demographic characteristics, Device: Change in sleepGroup of age-matched volunteers living in the same city |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- About 80 participants will be either full-time first-year undergraduate students attending the University of Aberdeen or age-matched non-university participants living in Aberdeen. Participants will be aged between 17-20 years. Both males and females will be recruited. Participants for the University categories will be recruited from across the range of programmes and living in (1) halls of residence (2) private accommodation (3) remaining at the family home. They may be UK or international students. The non-university volunteers may live in the family home or out of the home but must be recent high school graduates (within two years of graduating)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Over 20 years old,
- Pregnant/lactating, or taking medication which may affect their weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight and body composition change1- 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) | Device | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
| Change in dietary intake1. 24-hour recalls using Intake24 (online survey) over 3-day. 2. Self reported questionnaire. (Single measure) | Behavioural | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
| Change in physical activityAlso: Behavioral1. ActiGraph GT9X Link accelerometer over 7-day. 2. Self reported questionnaire. (Single measure) | Device | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
| Change in stress1- Self reported questionnaire. (Single measure) | Behavioural | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
| Change in socio-demographic characteristics1- Self reported questionnaire. (Single measure) | Behavioural | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
| Change in sleepActiGraph GT9X Link accelerometer over 7-day. (Single measure) | Device | Non-university participants living in Aberdeen, University students living at home, University students living in private accommodation, University students living in the halls of residence |
Primary outcome
Change in Body Weight (BW)
Time frame: Baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Weight (kilograms) will be measured using a Bioimpedance (Tanita MC-580 P).
Change in Body Mass Index (BMI)
Time frame: Baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one 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.
Change in Waist to Hip Ratio (WHR)
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one 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.
Change in Body Fat (BF%)
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Body Fat (BF%) will be measured by Bioimpedance (Tanita MC-580 P).
Change in Weight-for- Age Growth Charts
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
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).
Change in Finger Ratio
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one 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.
28 secondary outcomes
Change in Protein Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fat Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Carbohydrate Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Energy Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Alcohol Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sugars Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Non-milk Extrinsic Sugars Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fruit Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Vegetable Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Meat Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Processed Meat Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Poultry Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Fish Intake using intake24
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Dietary Intake using questionnaire
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 ).
Change in Physical Activity on Weekdays using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Physical Activity on Weekends using ActiGraph.
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in activity intensities using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Awake Duration on weekdays using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Awake Duration on Weekends using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sleep Duration on Weekdays using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Total Sleep Duration on Weekends using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Bedtime on Weekdays using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Bedtime on Weekends using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Wake Time on Weekdays using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Wake Time on Weekends using ActiGraph
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Physical Activity using questionnaire.
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in Stress using questionnaire
Time frame: baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.
Change in lifestyle behaviours using questionnaire
Time frame: After one year at university
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (BW) (time frame: Baseline at the beginning of the academic year, then a follow-up after three months, at eight months (end of the academic year ), and after one year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.