Trial from ANZCTR


Trial ID ACTRN12610000330044
Trial Status: Registered
Date Submitted: 21/04/2010
Date Registered: 23/04/2010
Retrospectively registered

Page 1

Public title Nutrition and Enjoyable Activity for Teenage Girls
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
Update:
 
Reason:
 
Secondary ID [1] 1435 0
Australian Research Council (DP - 1092646)
Update:
 
Reason:
 
UTN U1111-1113-7919
Update:
 
Reason:
 
Trial acronym NEAT Girls
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Behaviour 256067 0
Update:
 
Reason:
 
Intervention Code:
Prevention 256068 0
Update:
 
Reason:
 
Intervention Code:
Lifestyle 256345 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Body mass index (BMI). Height and weight - will be measured to using a portable scale and stadiometer. 258035 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 258035 0
Update:
 
Reason:
 
Primary Outcome: Fat mass and fat-free mass - will be determined using the Tanita BC-418MA Segmental Body Composition analyser. 258274 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 258274 0
Update:
 
Reason:
 
Secondary Outcome: Physical activity using accelerometers (MTI model 7164 and GT1M) 263602 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263602 0
Update:
 
Reason:
 
Secondary Outcome: Dietary behaviours -using the Australian Child and Adolescent Eating Survey (Watson et al, 2009). 263603 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263603 0
Update:
 
Reason:
 
Secondary Outcome: 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. 263604 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263604 0
Update:
 
Reason:
 
Secondary Outcome: Physical self-perception - will be assessed using scales from the Physical Self-Description Questionnaire (Marsh, Richards, Johnson, Roche, & Temayne, 1994). 263605 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263605 0
Update:
 
Reason:
 
Secondary Outcome: Sedentary behaviours- will be assessed using the Adolescent Sedentary Activity Questionnaire (Hardy, Booth & Okely, 2007). 263606 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263606 0
Update:
 
Reason:
 
Secondary Outcome: 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.
263607 0
Update:
 
Reason:
 
Timepoint: Baseline, 12-months and 24-months 263607 0
Update:
 
Reason:
 

Page 5

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.
Update:
 
Reason:
 
Minimum age 12 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age 15 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features Wait list control design. Participants assigned to the control group will receive the intervention at the completion of the study.
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 30/05/2010
Update:
 
Reason:
 
Date of first participant enrolment 1/03/2010
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled 30/03/2010
Update:
 
Reason:
 
Target sample size 380
Update:
 
Reason:
 
Recruitment status Closed: follow-up complete
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 256665 0
Update:
 
Reason:
 
Name: Australian Research Council 256665 0
Update:
 
Reason:
 
Address: 1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
AUSTRALIA

GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
256665 0
Update:
 
Reason:
 
Country: Australia 256665 0
Update:
 
Reason:
 
Primary Sponsor Government body
Update:
 
Reason:
 
Name: Australian Research Council
Update:
 
Reason:
 
Address: 1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
AUSTRALIA

GPO Box 2702
Canberra ACT 2601
Australia
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 256125 0
Update:
 
Reason:
 
Name: 256125 0
Update:
 
Reason:
 
Address: 256125 0
Update:
 
Reason:
 
Country: 256125 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: University of Newcastle Human Research Ethics Committee 258687 0
Update:
 
Reason:
 
Address: Callaghan Campus University Drive NSW 2308 258687 0
Update:
 
Reason:
 
Country: Australia 258687 0
Update:
 
Reason:
 
Approval Date: 21/01/2010 258687 0
Update:
 
Reason:
 
Submitted Date: 258687 0
Update:
 
Reason:
 
HREC: H-2009-0398 258687 0
Update:
 
Reason:
 
Brief summary The aim of this study is to evaluate the effects of a physical activity and nutrition program for low-active adolescent girls from economically disadvantaged secondary schools. The study will assess changes in body composition, physical activity, dietary behaviours, and hypothesized mediators of behaviour change over a 24 month period.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title: A/Prof
Update:
 
Reason:
 
30870 0
Name: David Lubans
Update:
 
Reason:
 
30870 0
Address: The University of Newcastle University Drive Callaghan NSW 2308
Update:
 
Reason:
 
30870 0
Country: Australia
Update:
 
30870 0
Reason:
 
Tel: +61 2 4921 2049
Update:
 
Reason:
 
30870 0
Fax: +61 2 4921 2084
Update:
 
Reason:
 
30870 0
Email: david.lubans@newcastle.edu.au
Update:
 
Reason:
 
30870 0
Contact person for public queries
Title: A/Prof
Update:
 
Reason:
 
14117 0
Name: A/Prof David Lubans
Update:
 
Reason:
 
14117 0
Address: School of Education Callaghan Campus University Drive NSW 2308
Update:
 
Reason:
 
14117 0
Country: Australia
Update:
 
14117 0
Reason:
 
Tel: +61 2 49212049
Update:
 
Reason:
 
14117 0
Fax: +61 2 49217407
Update:
 
Reason:
 
14117 0
Email: David.Lubans@newcastle.edu.au
Update:
 
Reason:
 
14117 0

Contact person for scientific queries
Title: A/Prof
Update:
 
Reason:
 
5045 0
Name: A/Prof
Update:
 
Reason:
 
5045 0
Address: School of Education Callaghan Campus University Drive NSW 2308
Update:
 
Reason:
 
5045 0
Country: Australia
Update:
 
5045 0
Reason:
 
Tel: +61 2 49212049
Update:
 
Reason:
 
5045 0
Fax: +61 2 49217407
Update:
 
Reason:
 
5045 0
Email: David.Lubans@newcastle.edu.au
Update:
 
Reason:
 
5045 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
23189 0
Name: A/Prof
Update:
 
Reason:
 
23189 0
Address: School of Education Callaghan Campus University Drive NSW 2308
Update:
 
Reason:
 
23189 0
Country:
Update:
 
23189 0
Reason:
 
Tel: +61 2 49212049
Update:
 
Reason:
 
23189 0
Fax: +61 2 49217407
Update:
 
Reason:
 
23189 0
Email: David.Lubans@newcastle.edu.au
Update:
 
Reason:
 
23189 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: