Weight Gain in First-year University Students

May 3, 2023 updated by: University of Aberdeen

The Impact of Living Arrangements, Dietary and Alcohol Intake, Physical Activity, and Stress on Weight Gain in First-year University of Aberdeen Students

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 study will assess the factors that predict students' weight gain during their first year at the University of Aberdeen. The change in lifestyle will be explored in relation to age-matched individuals not-attending university.

Study Overview

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 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 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.
  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.

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

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB24 3FX
        • University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
  1. 24-hour recalls using Intake24 (online survey) over 3-day.
  2. Self reported questionnaire. (Single measure)
  1. ActiGraph GT9X Link accelerometer over 7-day.
  2. Self reported questionnaire. (Single measure)
Other Names:
  • Behavioral
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)
  1. 24-hour recalls using Intake24 (online survey) over 3-day.
  2. Self reported questionnaire. (Single measure)
  1. ActiGraph GT9X Link accelerometer over 7-day.
  2. Self reported questionnaire. (Single measure)
Other Names:
  • Behavioral
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)
  1. 24-hour recalls using Intake24 (online survey) over 3-day.
  2. Self reported questionnaire. (Single measure)
  1. ActiGraph GT9X Link accelerometer over 7-day.
  2. Self reported questionnaire. (Single measure)
Other Names:
  • Behavioral
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)
  1. 24-hour recalls using Intake24 (online survey) over 3-day.
  2. Self reported questionnaire. (Single measure)
  1. ActiGraph GT9X Link accelerometer over 7-day.
  2. Self reported questionnaire. (Single measure)
Other Names:
  • Behavioral
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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