Trial Review

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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 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
Sex
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
27/02/2015
Date of last participant enrolment
Anticipated
Actual
24/03/2015
Date of last data collection
Anticipated
Actual
11/03/2016
Sample size
Target
60
Accrual to date
Final
29
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
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
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
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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.