Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000311358
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
28/02/2017
Date last updated
28/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
KOALA Healthy Life Program for promoting healthy lifestyles and weight in children with obesity.
Scientific title
The KOALA study, a randomised controlled trial of Lifestyle Triple P and Scouts QLD Active Camp program for overweight and obese children to promote healthier lifestyles and weight.
Secondary ID [1] 289790 0
'Nil known'
Universal Trial Number (UTN)
U1111-1185-8815
Trial acronym
KOALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
child obesity 299686 0
physical inactivity 299687 0
parenting skills 299688 0
Condition category
Condition code
Diet and Nutrition 299623 299623 0 0
Obesity
Metabolic and Endocrine 299624 299624 0 0
Other metabolic disorders
Public Health 299625 299625 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multidisciplinary intervention consisted of three components: (1) Group Lifestyle Triple P Positive Parenting Program; (2) Scouts Active Camp; and (3) dietetic consultations. The intervention was delivered to two cohorts given restrictions on the maximum number of parents able to attend programs at any one time.

Lifestyle Triple P
Lifestyle Triple P - Positive Parenting Program (West & Sanders, 2010) is an intensive, parent-only intervention for overweight or obese children aged 5 to 12 years. It targets dysfunctional parenting styles associated with childhood obesity and builds parental self-efficacy in managing a child’s lifestyle behaviour. It consisted of 16 sessions delivered over approximately 20 weeks, with 10 group sessions (2 hours each), and 6 individual telephone consultations (15-30 minutes each). Trained and accredited Triple P facilitators delivered the program using structured session checklists to ensure treatment fidelity.

Active Scouts Camp (intervention group only)
Scouts Queensland, a community organisation, offered 3 overnight family camps to each cohort approximately 6 weeks apart (following baseline, 6 weeks and 3 months later) at Scouts Queensland facilities at Mount Cotton and Victoria Park, Brisbane. There was no cost to participants. The target child, nominated parent/s, and siblings were all invited to attend each camp, to minimize any stigma associated with the camps being only for overweight or obese children in the family. The camp consisted of outdoor physical activities and team building exercises typical of those run by Scouts Queensland, and included group adventure walks, canoeing, and ball and tag games. No nutrition education sessions were delivered at the camp; however, the Queensland Association of School Tuckshops reviewed the camp food menu to ensure it matched National Healthy Eating Guidelines (NHMRC, 2003b).

Dietetic consultation
Four individualized consultations with a paediatric dietician were also provided at baseline, 1-, 2-, and 4-months. The consultations obtained information related to dietary intake of core food groups and recommended. Individualised meal plans were devised and issues relating to diet were problem-solved.

Intervention code [1] 295456 0
Lifestyle
Intervention code [2] 295457 0
Behaviour
Intervention code [3] 295458 0
Prevention
Comparator / control treatment
Participants were randomly allocated to either the intervention or care as usual.
Participants in the care as usual condition attended assessment at baseline, 6- and 12-months follow-up. All participants had a consultation with the same pediatric endocrinologist for a psychosocial and physical assessment. Participants were encouraged to visit their general practitioner every two months between assessments.

All participants (intervention and control " care as usual " group were also given unrestricted access to a specifically developed website for the KOALA study, ‘KOALA at Mater – Healthy Lifestyle Promotion, Education and Research Program’, which included healthy tips and resources based on the Australian national guidelines for Physical activity and Sedentary guidelines or for Nutrition for adults and children . Information sheets were also provided with healthy living tips (including from the Australian national guidelines for physical activity and nutrition as mentioned above) and from the We Can NIH, USA website (Ways to enhance Children's Activity and Nutrition) promoting lifestyle messages and engagement in physical and community activities.

These tip sheets included
“Using Glycemic Index – As simple as healthy eating” (Diabetes Australia)
“Food for health – A guide to healthy eating”
“It’s easy to find a way to get some extra fruit and vegies in your day”
“Active kids are healthy kids” (Australian Government Department of Health and Aging)
“Active After School Communities” (Australian Sports Commission)
C.S.I.R.O. “Wellbeing Plan For Aussie Kids” Fact Sheets: Give thirsty kids water, Help young bones grow, Vegies add vitality, Grains are great, Think healthy snacks, Start with breakfast, Recreational screen time, Help kids be active, Be a healthy role model, Shop smartly.
Control group
Active

Outcomes
Primary outcome [1] 299093 0
Body Mass index (BMI z score) Anthropometric measurements
Height was measured using a Seca 2200 stadiometer (Hamburg, Germany) within 0.1 cm, and weight was recorded on Digital Wheelchair Scales Model BS-110 within 0.1 kg. Children were barefoot and wore light clothing. Body mass index (BMI) and BMI z-scores were calculated using the United States Centre for Disease Control (CDC) 2000 child reference data (Kuczmarski et al., 2000).
Timepoint [1] 299093 0
Upon entry into the study, and 6 and 12 months later
Primary outcome [2] 299094 0
parenting styles (Parenting Scale scores)
The Parenting Scale (PS; Arnold, O’Leary, Wolff, & Acker, 1993) is a 30-item measure of overall parenting style (PS Total), and three dysfunctional discipline styles: Laxness (permissive discipline), Overreactivity (displays of anger), and Verbosity (overly long reprimands). The PS had good internal consistency for Total a = .92, Laxness a = .92, and Overreactivity a = .88, but poor for Verbosity a = .53.
Timepoint [2] 299094 0
Upon entry into the study, and 6 and 12 months later
Primary outcome [3] 299714 0
Child behaviour (Lifestyle Behaviour Checklist scores and Strengths and Difficulties Questionnaire (DASS) scores)
The Lifestyle Behaviour Checklist (LBC; West & Sanders, 2009) was used to assess parental confidence in dealing with 25 lifestyle-specific problem behaviours. Excellent internal consistency was found for the LBC Confidence scale (a = .95).
Timepoint [3] 299714 0
Upon entry into the study, and 6 and 12 months later
Secondary outcome [1] 326121 0
"This is a composite secondary outcome"

Change in body composition (body fat and skeletal muscle mass) assessed by Magnetic resonance imaging (MRI) and spectroscopy (MRS) and bioelectrical impedance.
Bioelectrical impendence analysis (BIA; Body Stat 1500MDD, Bodystat Ltd, Douglas, UK) was used to assess body composition. Measurements were taken in the still supine position after initial rest period of 15 minutes as previously described by Cleary and colleagues (2008). A validated BIA equation of Schaefer and colleagues (1994) was used to calculate fat free mass (kilograms), percentage of fat mass (as a percentage of total body weight), and lean percent (as a percentage of total body weight).
Timepoint [1] 326121 0
Upon entry into the study, and 6 and 12 months later
Secondary outcome [2] 326122 0
"This is a composite secondary outcome"
Change in metabolic biomarkers of insulin sensitivity/resistance and inflammation (including total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (TG) levels and homeostatic model insulin resistance assessment (HOMA-IR)).
Timepoint [2] 326122 0
Upon entry into the study and 12 months later
Secondary outcome [3] 327931 0
"This is a composite secondary outcome"

Proportion of participants with an improvement in Parent adjustment (Depression Anxiety and Stress Scale) and relations (Relationship Quality Index and Parent Problem Checklist)
Parent relations
The Relationship Quality Index (RQI; Norton, 1983) is a 6-item measure assessing relationship quality and satisfaction. Internal consistency was excellent (a = .93).
The Parent Problem Checklist (PPC; Dadds & Powell, 1991) assesses inter-parental conflict over childrearing. The PPC Extent scale rates the degree of disagreement over rules and discipline. Internal consistency with the current sample was high (a = .88).


Timepoint [3] 327931 0
Upon entry into the study, and 6 and 12 months later

Eligibility
Key inclusion criteria
Inclusion criteria were as follows: (a) the child was aged 6-10 years; (b) at least one parent or guardian was willing to participate; and (c) the child’s body mass index was greater than or equal to the 85th percentile-for-age according to Centre for Disease Control (CDC) criteria . Participants were ineligible if: (1) the child had hypertension, obstructive sleep apnoea, Type 2 Diabetes Mellitus, a genetic obesity-related syndrome, or orthopaedic complications of obesity; (2) the child was diagnosed with a neurodevelopmental disorder; (3) the child had emotional or behavioural problems; and (4) child had current or past history of taking medications known to affect weight or growth.

A cohort of ~40 age and sex-matched healthy volunteer children with healthy BMI between >3 to less than 85th centile were also recruited as healthy volunteer controls to undergo the same baseline assessment as the overweight and obese children also underwent.
Minimum age
6 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A chronic disease or illness including any physical, psychological or mental health condition that would impair physical activity or participation in a Scouts Active camp program.

Medication that would affect weight gain (e.g corticosteroids, ant-epileptics, psychotropic drugs).

Lack of informed consent and assent.

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)
Independent biostatisticians randomised participants using a sequentially numbered sealed opaque envelope system. Once participant consent was obtained, research staff opened the envelope and participants were informed of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random sampling was used according to age (2 groups: 6-8 years and 9-10 years) and child body mass index (2 groups: overweight [85th-95th percentile] and obese [>95th percentile]) to ensure an equal distribution between conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of repeated-measures multivariate and univariate analyses of covariance will be conducted to evaluate the short-term intervention and maintenance effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/07/2007
Date of last participant enrolment
Anticipated
Actual
13/10/2008
Date of last data collection
Anticipated
Actual
6/11/2009
Sample size
Target
130
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6757 0
Mater Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 14402 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294171 0
Charities/Societies/Foundations
Name [1] 294171 0
The Golden Casket Medical Foundation
Country [1] 294171 0
Australia
Funding source category [2] 295525 0
Charities/Societies/Foundations
Name [2] 295525 0
The Royal Australasian College of Physicians Research Foundation Merrill Lynch Award
Country [2] 295525 0
Australia
Funding source category [3] 295526 0
Charities/Societies/Foundations
Name [3] 295526 0
The Mazda Foundation
Country [3] 295526 0
Australia
Funding source category [4] 295527 0
Charities/Societies/Foundations
Name [4] 295527 0
Mater Children's Hospital Golden Casket Funds
Country [4] 295527 0
Australia
Primary sponsor type
Hospital
Name
Mater Children's Hospital
Address
Stanley Street
South Brisbane QLD 4010
Country
Australia
Secondary sponsor category [1] 293032 0
University
Name [1] 293032 0
The University of Queensland
Address [1] 293032 0
Carmody Rd, St.Lucia, Queensland 4072
Country [1] 293032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296175 0
Mater Health Services Human Ethics Committee
Ethics committee address [1] 296175 0
Ethics committee country [1] 296175 0
Australia
Date submitted for ethics approval [1] 296175 0
01/05/2007
Approval date [1] 296175 0
03/09/2007
Ethics approval number [1] 296175 0
HREC14MHS79
Ethics committee name [2] 296176 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 296176 0
Ethics committee country [2] 296176 0
Australia
Date submitted for ethics approval [2] 296176 0
24/05/2007
Approval date [2] 296176 0
08/06/2007
Ethics approval number [2] 296176 0
#2007000728

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

Contacts
Principal investigator
Name 67826 0
A/Prof Gary M. Leong
Address 67826 0
Dept of Paediatric Endocrinology, Lady Cilento Children's Hospital, Stanley Street,
South Brisbane, QLD 4010
Country 67826 0
New Zealand
Phone 67826 0
+61 7 3068 1111
Fax 67826 0
+61 7 3068 4949
Email 67826 0
[email protected]
Contact person for public queries
Name 67827 0
Gary M. Leong
Address 67827 0
Dept of Paediatric Endocrinology, Lady Cilento Children's Hospital, Stanley Street,
South Brisbane, QLD 4010
Country 67827 0
Australia
Phone 67827 0
+61 7 3068 1111
Fax 67827 0
+61 7 3068 4949
Email 67827 0
[email protected]
Contact person for scientific queries
Name 67828 0
Gary M. Leong
Address 67828 0
Dept of Paediatric Endocrinology, Lady Cilento Children's Hospital, Stanley Street,
South Brisbane, QLD 4010
Country 67828 0
Australia
Phone 67828 0
+61 7 3068 1111
Fax 67828 0
+61 7 3068 4949
Email 67828 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.