Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000921987
Ethics application status
Approved
Date submitted
25/08/2011
Date registered
29/08/2011
Date last updated
22/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fanau FAB: Parent-focused Food, Activity, Behaviour Programme to reduce obesity in Pacific children
Scientific title
Effect of a parent-focused weight management programme on BMI z-scores of Pacific children aged 5 - 12 years compared with existing community-based clinical service
Secondary ID [1] 262940 0
Nil
Universal Trial Number (UTN)
U1111-1123-9963
Trial acronym
Fanau FAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 270644 0
Physical inactivity 270649 0
Lifestyle behaviour 270650 0
Obesity 270651 0
Condition category
Condition code
Public Health 270818 270818 0 0
Epidemiology
Public Health 270819 270819 0 0
Health service research
Diet and Nutrition 270822 270822 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline measurements, 8 weeks intervention programme (eight 1.5-hour FAB group treatment sessions), followed by maintenance phase of 26 weeks post-intervention. Follow-up measurements at 26 weeks post-intervention. Fanau FAB intervention is a parent-focused programme for overweight and obese children aged 5-12 years and at least one parent/primary caregiver per child participant. The intervention will be delivered by Facilitators with training, support and mentoring provided by Inspiring Limited staff. Back-up support will be provided by the Fanau FAB research team with overall oversight provided by the Study Manager. Participants will attend eight group therapy sessions. Each session will be for 1.5 hours per week. At each session, children will be engaged separately in games and FAB activities while their parents/primary caregivers will be supported with information, goal setting, tasks, and the group process of sharing their lived experiences around FAB - Food, Activity, Behaviour. Both parents/primary caregivers and children will engage in a family activity in the first half hour of each session. The content for the intervention will include: 1. Introductions, Overview, Goal setting, Relationship-building 2. Repeat Introductions, Overview, Goal setting, Relationship-building 3. Improving food/drink choices, Family Plan 4. Enhancing motivation, Reducing Sedentary Behaviour, Review Family Plan5. Modelling and family eating patterns, Review Family Plan 6. Maintaining Healthy Lifestyle Behaviours 7. Reinforce Relationships and Parenting skills. Revisit Family Plan. 8. Preventing Relapse, Coping Strategies, Revisit Family Plan. Upon completion of the eight weeks programme, the Fanau FAB Research Team will provide maintenance support with one home visit per family and follow-up phone calls (1 per week per family). Children and their families will also be referred to local community sports and exercise/recreation programmes. The Fanau FAB team will comprise Researchers, Paediatrician, Physical Activity Instructor. They will be supported with clinical, management and intervention programme support through study collaborators.
Intervention code [1] 269273 0
Treatment: Other
Intervention code [2] 269276 0
Behaviour
Intervention code [3] 269277 0
Lifestyle
Comparator / control treatment
Existing community-based clinical service, Kids in Action. KIA is a child-focused programme for overweight and obese children aged 8 - 18 years. The programme provides support for children and families with food choices and eating behaviours, as well as physical fitness and activities. Exercise programmes are provided every Monday and Wednesday after school for 10 weeks at a local recreation centre with regular home visits every 2-4 weeks within 10 weeks programme i.e. approximately 2-3 home visits per family. After the 10 weeks programme children and their families are referred to local community sports and exercise/recreation programmes. The KIA team is made up of a nurse, paediatrician, dietician, and sports and fitness coach.
Control group
Active

Outcomes
Primary outcome [1] 279512 0
Change in BMI z-score of child participants from baseline to 26 weeks post-intervention.
Timepoint [1] 279512 0
26 weeks post-intervention.
Secondary outcome [1] 287799 0
Percent (%) body fat in children assessed by bioelectrical impedance.
Timepoint [1] 287799 0
Baseline to 26 weeks post-intervention.
Secondary outcome [2] 287800 0
Waist circumference (cm and z-score) in children.
Timepoint [2] 287800 0
Baseline to 26 weeks post-intervention.
Secondary outcome [3] 287801 0
Height (cm and z-score) in children.
Timepoint [3] 287801 0
Baseline to 26 weeks post-intervention.

Eligibility
Key inclusion criteria
1. Above age-determined cut-off point for overweight and obesity 2. Identify with Pacific ethnic group 3. Aged between 5 - 12 years 4. Resident of South Auckland throughout study
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Heart disease
2. Severe asthma
3. Type 1 diabetes
4. Moderate or severe retardation
5. Disability which may hampter ability to exercise/play
6. Leg/hand in cast will interfere with bioelectrical impedance measurements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from local communities, Pacific health service providers, churches and schools. Recruitment will be facilitated through the media and other networks. Immediately following baseline data collection, randomisation allocation will be determined and participants will be randomly assigned to either:
Group 1: Fanau FAB intervention programme; or
Group 2: Kids in Action (KIA) programme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified blocked randomisation with variable block sizes (i.e. multiple if two arms) will be used to maintain balance across important prognostic factors. Two stratification factors will be considered: gender (female and male) and preferred ethnicity (Samoan, Tongan, Cook Island Maori, and Other Pacific). Allocation concealment by computer up to the point of randomisation will be maintained.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3809 0
New Zealand
State/province [1] 3809 0
Auckland

Funding & Sponsors
Funding source category [1] 269736 0
Government body
Name [1] 269736 0
Health Research Council of New Zealand
Country [1] 269736 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
School of Population Health
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 268779 0
None
Name [1] 268779 0
Address [1] 268779 0
Country [1] 268779 0
Other collaborator category [1] 252229 0
Other Collaborative groups
Name [1] 252229 0
Auckland UniServices Limited
Address [1] 252229 0
Clinical Trials Research Unit
School of Population Health
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland, 1142
Country [1] 252229 0
New Zealand
Other collaborator category [2] 252230 0
Other
Name [2] 252230 0
Inspiring Limited
Address [2] 252230 0
P O Box 28854
Remuera
Auckland 1541
Country [2] 252230 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271701 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 271701 0
Ethics committee country [1] 271701 0
New Zealand
Date submitted for ethics approval [1] 271701 0
20/07/2011
Approval date [1] 271701 0
09/08/2011
Ethics approval number [1] 271701 0
2010/554

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

Contacts
Principal investigator
Name 33074 0
Address 33074 0
Country 33074 0
Phone 33074 0
Fax 33074 0
Email 33074 0
Contact person for public queries
Name 16321 0
Ofa Dewes
Address 16321 0
Pacific Health Section
School of Population Health
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 16321 0
New Zealand
Phone 16321 0
+64-9-9239354
Fax 16321 0
+64-9-3737624
Email 16321 0
[email protected]
Contact person for scientific queries
Name 7249 0
Teuila Percival or Robert Scragg
Address 7249 0
School of Population Health
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 7249 0
New Zealand
Phone 7249 0
+64-9-3737599
Fax 7249 0
Email 7249 0
[email protected] or [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.