Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000330044
Ethics application status
Approved
Date submitted
21/04/2010
Date registered
23/04/2010
Date last updated
25/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition and Enjoyable Activity for Teenage Girls
Scientific title
Group randomised controlled trial to assess the effect of a school-based
intervention promoting physical activity and healthy eating on body mass
index and body composition in low-active adolescent girls from
disadvantaged secondary schools
Secondary ID [1] 1435 0
Australian Research Council (DP - 1092646)
Universal Trial Number (UTN)
U1111-1113-7919
Trial acronym
NEAT Girls
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 256878 0
physical inactivity 257236 0
Poor dietary behaviours 257237 0
Low physical self-esteem 257238 0
Condition category
Condition code
Public Health 257026 257026 0 0
Health promotion/education
Diet and Nutrition 257373 257373 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the Nutrition and Enjoyable Activity for Teenage Girls (NEAT Girls) program, which is a 12-month school-based physical activity and dietary intervention for low-active adolescent girls from economically disadvantaged secondary schools. The program will provide students with an opportunity to increase their knowledge, skills and attitudes toward physical activity and nutrition. The NEAT Girls program was developed in reference to Bandura's Social Cognitive Theory and will target the following mediators of behaviour change: self-efficacy, social support, personal regulation of health behaviour, environmental perceptions, outcome expectations and expectancies. The intervention will include the following components:

(i) School sport physical activity sessions: An enhanced school sport program will be delivered during timetabled school sport (90 minutes/week x 40 weeks). During these sessions, students will participate in enjoyable lifetime activities (e.g. Pilates, yoga, aerobics, resistance training, dance, and boxing fitness) that aim to provide novel physical activity experiences not normally provided during physical education or school sport. The lifetime activity sessions will focus on fun, peer support and development of knowledge and skills around physical activity and fitness. A didactic component of the school sport sessions will deliver key messages and strategies for being physically active and healthy eating. These messages will focus on a revised version of the 10 key physical activity and nutrition messages from the successful pilot study Program X (eg. “Aim to eat 2 servings of fruit and 5 servings of vegetables each day”, “Regular physical activity is easier to achieve when you plan to participate with a friend or family member”).
(ii) Lunchtime physical activity sessions: These sessions (30 minutes) will also have a lifetime activity focus and will be scheduled to follow on from the weekly school sport session for three school terms. The aim of these sessions is to encourage study participants to become “Physical Activity Leaders” in their school by taking ownership of the 30 minute weekly workouts. Study girls will be encouraged to run these sessions and invite their friends and younger peers to participate, thereby becoming physical activity role-models. Specific leadership challenges and tasks will provide study participants with an opportunity to achieve a “physical activity leader” accreditation within the school.
(iii) Interactive seminars: Three informational seminars will be delivered during the 12-month intervention period. The first seminar will introduce key messages and strategies for being physically active and healthy eating at the beginning of the intervention. The second seminar will occur mid-intervention and will have a “physical activity leaders” focus to complement the aim of the lunchtime physical activity sessions. The final seminar will take place at the conclusion of the intervention and will review key physical activity and dietary messages from the intervention.
(iv) Pedometers for physical activity monitoring: Participants will be provided with pedometers to use as a motivational tools. A number of individual and group challenges that encourage goal-setting and physical activity by using the pedometers will be organised throughout the intervention period (eg. group challenges through step-count or distance accumulation over a set period of time).
(v) Text messaging – Participants will be provided with social support for physical activity and healthy eating using automated text messaging. Messages will be provided by the research team and will reinforce key messages from the information sessions and provide encouragement for healthy behaviours. For individuals who do not have a phone that can receive text messages, the same information will be distributed via email, which can be accessed at the school.
(vi) Parent newsletters: Parents will be provided with monthly newsletters for a period of 12-months which aim to reinforce key messages and strategies delivered to students during information sessions, and encourage family support in the home environment for healthy eating and physical activity.
Intervention code [1] 256067 0
Behaviour
Intervention code [2] 256068 0
Prevention
Intervention code [3] 256345 0
Lifestyle
Comparator / control treatment
Wait list control. Students in the control group will receive standard treatment (ie. regular school sport program + health and physical education curriculum) during the intervention period and will receive a condensed version of the intervention at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 258035 0
Body mass index (BMI). Height and weight - will be measured to using a portable scale and stadiometer.
Timepoint [1] 258035 0
Baseline, 12-months and 24-months
Primary outcome [2] 258274 0
Fat mass and fat-free mass - will be determined using the Tanita BC-418MA Segmental Body Composition analyser.
Timepoint [2] 258274 0
Baseline, 12-months and 24-months
Secondary outcome [1] 263602 0
Physical activity using accelerometers (MTI model 7164 and GT1M)
Timepoint [1] 263602 0
Baseline, 12-months and 24-months
Secondary outcome [2] 263603 0
Dietary behaviours -using the Australian Child and Adolescent Eating Survey (Watson et al, 2009).
Timepoint [2] 263603 0
Baseline, 12-months and 24-months
Secondary outcome [3] 263604 0
Health related fitness- core abdominal strength and upper-body strength will be assessed by using the prone hold assessment and timed push-up test respectively.
Timepoint [3] 263604 0
Baseline, 12-months and 24-months
Secondary outcome [4] 263605 0
Physical self-perception - will be assessed using scales from the Physical Self-Description Questionnaire (Marsh, Richards, Johnson, Roche, & Temayne, 1994).
Timepoint [4] 263605 0
Baseline, 12-months and 24-months
Secondary outcome [5] 263606 0
Sedentary behaviours- will be assessed using the Adolescent Sedentary Activity Questionnaire (Hardy, Booth & Okely, 2007).
Timepoint [5] 263606 0
Baseline, 12-months and 24-months
Secondary outcome [6] 263607 0
Mediators of physical activity and dietary behaviour change- a questionnaire will be used to assess the following- physical activity and nutrition self-efficacy, social support for physical activity and healthy eating, physical activity and nutrition intentions, physical activity and nutrition outcome expectations and expectancies, behavioural strategies for physical activity and healthy eating, environmental perceptions of the physical activity and nutrition environments.
The questionnaires were developed for the current study.
Timepoint [6] 263607 0
Baseline, 12-months and 24-months

Eligibility
Key inclusion criteria
Adolescent girls in Year 8 (age 12-15) attending a secondary school in areas of low-socioeconomic status (SES). Schools will be classified as low-SES based on having a Socio-Economic Indexes for Areas (SEIFA) of less than or equal to 5. Girls will be identified as low-active by physical education teachers at the study schools.
Minimum age
12 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they currently play organised competitive team or individual sports or if they have a medical condition or physical injury preventing testing or participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Twelve low socio-economic status (SES) secondary schools from the Hunter/Central Coast Region will be invited to participate in the study. Schools will be classified as low-SES based on having a SEIFA index of less than or equal to 5.
Schools that satisfy the criteria above will be initially contacted by letter. School principals will be sent an Information Statement and Consent Letter inviting their school to participate in the study. Once schools have expressed interest in the project, the Program Manager will contact the schools and request an opportunity to present the research proposal to the physical education (PE) teaching staff. The PE staff will then be asked to identify students who they perceive to be low-active and/or not currently participating in organised sport or physical activity. Interested students will be provided with information and consent letters. Once baseline data has been collected, randomisation will occur at the school level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation method of coin tossing will be used to allocate schools to treatment conditions. This method ensures an equal chance of allocation to each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive the intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2010
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
30/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256665 0
Government body
Name [1] 256665 0
Australian Research Council
Country [1] 256665 0
Australia
Primary sponsor type
Government body
Name
Australian Research Council
Address
1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
AUSTRALIA

GPO Box 2702
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 256125 0
None
Name [1] 256125 0
Address [1] 256125 0
Country [1] 256125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258687 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 258687 0
Ethics committee country [1] 258687 0
Australia
Date submitted for ethics approval [1] 258687 0
Approval date [1] 258687 0
21/01/2010
Ethics approval number [1] 258687 0
H-2009-0398

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30870 0
A/Prof David Lubans
Address 30870 0
The University of Newcastle University Drive Callaghan NSW 2308
Country 30870 0
Australia
Phone 30870 0
+61 2 4921 2049
Fax 30870 0
+61 2 4921 2084
Email 30870 0
[email protected]
Contact person for public queries
Name 14117 0
A/Prof David Lubans
Address 14117 0
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 14117 0
Australia
Phone 14117 0
+61 2 49212049
Fax 14117 0
+61 2 49217407
Email 14117 0
[email protected]
Contact person for scientific queries
Name 5045 0
A/Prof
Address 5045 0
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 5045 0
Australia
Phone 5045 0
+61 2 49212049
Fax 5045 0
+61 2 49217407
Email 5045 0
[email protected]

No information has been provided regarding IPD availability


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.