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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001116516
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
23/10/2015
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Date results information initially provided
22/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of first yearuniversity students’ body weight and lifestyle.
Scientific title
Weight, dietary and physical activity patterns, of newly enrolled undergraduate students over 12 months
Secondary ID [1] 286408 0
Nil
Universal Trial Number (UTN)
U1111-1168-2424
Trial acronym
UniStArt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 294566 0
Condition category
Condition code
Diet and Nutrition 294872 294872 0 0
Obesity
Public Health 296775 296775 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a prospective observational study that consists of: 1 baseline visit, and 12 monthly follow-up visits.

The baseline visit (90 minutes) involves: the measurement of body height (Seca stadiometer), body weight (Tanita scale) and body fat % (bioelectrical impedence method), waist and hip circumference measurements (measuring tape), self-administered questionnaires on demographic/study load information, food knowledge (General Nutrition Knowledge Questionnaire), habitual food intake (3-day food diaries), physical activity patterns (International Physical Activity Questionnaire), eating behaviours (Three-Factor Eating Questionnaire), and resting energy expenditure measurement using an indirect calorimeter (Truemax 1200, ParvoMedic Inc.).

Monthly follow-up visits will be conducted for the next 12 months after the baseline visit. During all follow-up visits, body weight and body composition measurements will be repeated. At 3 months, 6 months, and 9 months, height will be taken using a stadiometer, and demographic/study load information, physical activity patterns and eating behaviours will be reassessed using questionnaires. Dietary intake will also be assessed using a 3-day food diary.

At the final visit, all measurements taken at baseline will be repeated.

In total, the study will require 6 hours (over the 12 months) to complete, as the baseline and final visits will require about 90 minutes each, standard follow-up visits involving weight measurements only will take 10 minutes and follow up visits when additional information on dietary intake and physical activity is required will take 30 minutes.
Intervention code [1] 291479 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294622 0
Body weight - via Tanita body scales
Timepoint [1] 294622 0
Every month from baseline to 12 months (13 visits)
Primary outcome [2] 294623 0
body fat % assessed by bioelectrical impedence
Timepoint [2] 294623 0
Every month from baseline to 12 months (13 visits)
Secondary outcome [1] 313734 0
Waist and hip circumference measurements with a measuring tape
Timepoint [1] 313734 0
Every 3 months (0, 3, 6, 9, and 12 months)
Secondary outcome [2] 313735 0
Resting energy expenditure measured with TrueOne 2400 Metabolic Measurement System –Parvomedics Inc.
Timepoint [2] 313735 0
At baseline and final visit at 12 months
Secondary outcome [3] 313736 0
Habitual food intake with 3-day food diary
Timepoint [3] 313736 0
Every 3 months (0, 3, 6, 9, and 12 months)
Secondary outcome [4] 313737 0
Demographic questionnaire taht has been specifically designed for this study of university students
Timepoint [4] 313737 0
Every 3 months (0, 3, 6, 9, and 12 months)
Secondary outcome [5] 313738 0
Physical activity patterns assess by INternational Physical Activity Questionnaire (IPAC) questionnaire
Timepoint [5] 313738 0
Every 3 months (0, 3, 6, 9, and 12 months)
Secondary outcome [6] 313739 0
Eating behaviour assessed by Three-factor Eating Questionnaire
Timepoint [6] 313739 0
Every 3 months (0, 3, 6, 9, and 12 months)
Secondary outcome [7] 313740 0
Nutrition knowledge assessed by General Nutrition Knowledge Questionnaire
Timepoint [7] 313740 0
Every 3 months (0, 3, 6, 9, and 12 months)

Eligibility
Key inclusion criteria
- Newly enrolled university undergraduate students
- Overall healthy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have studied in the past 5 years at University
- Participants receiving their nutrition either via naso-gastric (NG) tube or Percutaneous endoscopic gastrostomy (PEG)
- Chronic conditions which affect dietary intake or absorption of nutrients or body weight

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To detect a significant weight gain of 6.8kg in our study sample (mean = 65.5kg and SD = 18.9kg) at 80% statistical power and alpha=0.05, 48 participants will be required. To account for dropouts, a total of 60 participants will be recruited (20% attrition rate).
Descriptive, repeated measures ANOVA, correlation, linear regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9395 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290978 0
University
Name [1] 290978 0
University of South Australia
Address [1] 290978 0
School of Pharmacy and Medical Sciences, City East Campus, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country [1] 290978 0
Australia
Primary sponsor type
Individual
Name
Evangeline Mantzioris
Address
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country
Australia
Secondary sponsor category [1] 289656 0
Individual
Name [1] 289656 0
Sze Yen Tan
Address [1] 289656 0
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country [1] 289656 0
Australia
Secondary sponsor category [2] 289657 0
Individual
Name [2] 289657 0
Anthony Villani
Address [2] 289657 0
School of Pharmacy and Medical Sciences, City East Campus, North Terrace, University of South Australia, GPO Box 2471, Adelaide SA, 5001
Country [2] 289657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292570 0
University of South Australia’s Human Research Ethics Committee
Ethics committee address [1] 292570 0
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, GPO Box 2471, Adelaide SA 5001
Ethics committee country [1] 292570 0
Australia
Date submitted for ethics approval [1] 292570 0
20/10/2014
Approval date [1] 292570 0
24/10/2014
Ethics approval number [1] 292570 0
0000033624

Summary
Brief summary
This study aims to identify what the impact of young adults in their first year of university has on behaviours and choices made around diet and exercise, and how this may impact on nutritional intake, physical activity and anthropometric measures. This concept has been fuelled by longitudinal studies from the US which have consistently demonstrated an increase in weight during the first year of university with the rate of weight gain in university students determined to be 5.5 times greater than the general community. To date there has been no study in Australia documenting dietary and physical activity levels in first year undergraduate students and the impact on weight.

As obesity is a growing health concern in young adults in Australia, it is important to identify how the influences involved in the transition period from high school to university, as well as observing changes in overall health and lifestyle patterns, may guide universities and health practitioners in providing advice and strategies on healthy and sustainable choices that can be made around diet and exercise to prevent further weight gain as a result of a new environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56010 0
Dr Evangeline Mantzioris
Address 56010 0
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country 56010 0
Australia
Phone 56010 0
+61883022574
Fax 56010 0
Email 56010 0
evangeline.mantzioris@unisa.edu.au
Contact person for public queries
Name 56011 0
Dr Evangeline Mantzioris
Address 56011 0
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country 56011 0
Australia
Phone 56011 0
+61883022574
Fax 56011 0
Email 56011 0
evangeline.mantzioris@unisa.edu.au
Contact person for scientific queries
Name 56012 0
Dr Evangeline Mantzioris
Address 56012 0
School of Pharmacy and Medical Sciences, City East Campus, University of South Australia, North Terrace, GPO Box 2471, Adelaide SA, 5001
Country 56012 0
Australia
Phone 56012 0
+61883022574
Fax 56012 0
Email 56012 0
evangeline.mantzioris@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain confidentiality as this was not part of the original participant consent.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 372 0
Presentation
Citation/DOI/link/details [1] 372 0
Wilson, N., Villani, A., Tan, SY. & Mantzioris, E. (2016, May). Body weight, dietary intake, and physical activity levels of first-year university students: A longitudinal observational study. Presentation at the Australian and New Zealand Eating Disorders and Obesity Conference, Surfers Paradise, AUS.
Attachments [1] 372 0
Citation type [2] 373 0
Conference abstract
Citation/DOI/link/details [2] 373 0
Mantzioris, E., Wilson, N., Tan, SY. & Villani, A. (2016, November). Australian first-year university students are not meeting Australian Guide to Healthy Eating guidelines. Poster presented at the Nutrition Society of Australia Annual Scientific Meeting, Melbourne, AUS.
Attachments [2] 373 0
Results – plain English summary
Students in the United States gain weight significantly during their first year of university but limited data is available for Australian students. This 12-month observational study was conducted to monitor body weight, diet and lifestyle changes amongst first-year Australian university students. Participants were first-year university students over 18 years. Twenty-two first-year university students completed the study and were analysed. Changes in body weight and body composition were assessed monthly, while basal metabolic rate, dietary intake, physical activity levels, and eating behaviours were assessed quarterly. Female students gained weight significantly at two, three and four-months. Female waist circumference (2.5cm increase at two-months) and body fat also increased. Intake of sugar, saturated fat and sodium exceeded recommended levels at 12-months. Greater sedentary behaviours were observed amongst male students throughout the study. Female students are at risk of unfavourable changes in body composition during the first year of university, while males are at risk of increased sedentary behaviours. High intakes of saturated fat, sugars and sodium warrant future interventions in such a vulnerable group.