Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000749202
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
28/08/2009
Date last updated
4/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening, feedback and treatment in overweight 4-8 year old children: the MInT study
Scientific title
The use of motivational interviewing for screening and feedback of weight status in overweight 4-8year old children and the effect on body mass index of a tailored family-based approach: the MInT study
Secondary ID [1] 282747 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MInT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity in children 243466 0
Condition category
Condition code
Public Health 239768 239768 0 0
Other public health
Diet and Nutrition 239882 239882 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MInT has a two-stage study design: 1) screening and feedback and 2) treatment.

1) Screening and feedback: 1500 children aged 4-8 years will attend well child health checks. Parents of children with body mass index (BMI) values less than the 85th percentile of age- and sex-specific reference norms (Center for Disease Control (CDC)) will be informed of their child's weight and will not participate further in the study. Children who are overweight (BMI greater than or equal to the 85th percentile, estimate 400) will be randomised to one of two feedback mechanisms: Business as Usual versus motivational interviewing (MI). Trained staff will interact with families to deliver the feedback in the appropriate manner. MI is a non-judgemental, empathetic style of counseling which encourages individuals (or families) to “buy into” changing behaviours. For those randomised to the Business as Usual feedback condition, the research nurse will discuss the results briefly with the families, using a report card which details the results. In the motivational interviewing condition, the same report card would be used but the nurse will use MI to discuss the BMI findings in a way that allows parents to explore their reactions to the information and what they might be able to do in response. Two weeks later they will be reinterviewed to assess their reactions to feedback (benefits, harm, perceived behaviour change).

2) Treatment: All 400 overweight children will be invited into a two-year family-based weight management programme. They will be randomised to one of two treatment conditions: usual care versus tailored treatment. Those in the usual care condition will meet once with a nurse to receive a single 30 minute session detailing general healthy eating and physical activity advice. Those in the tailored treatment condition will meet once with an expert team to develop goals and solutions that are family-based and tailored to each individual family. Each family will then meet regularly with their mentor who will assist them with their progress (using motivational interviewing where appropriate). Frequency of contact will decrease over two years from initially weekly to three-monthly.
Intervention code [1] 237080 0
Lifestyle
Intervention code [2] 241185 0
Behaviour
Intervention code [3] 241186 0
Treatment: Other
Comparator / control treatment
The control group will receive weight-related feedback in a "usual care" manner for the feedback condition. For the intervention, the control group will receive a single 30 minute session detailing general healthy eating and physical activity advice. They will then be referred back to their general practitioner (GP) for further care. Additional visits to their GP will be monitored through the study.
Control group
Active

Outcomes
Primary outcome [1] 240532 0
BMI z-score - BMI will be calculated as weight in kilograms divided by height in metres squared. BMI will then be convered to z-scores using the age- and sex-specific CDC reference data
Timepoint [1] 240532 0
Baseline, and 12 and 24 months following randomisation
Secondary outcome [1] 257097 0
Physical activity (Actigraph accelerometry)
Timepoint [1] 257097 0
Baseline, and 12 and 24 months following randomisation
Secondary outcome [2] 257098 0
Food behaviours and intake will be assessed using a modified version of the Home Food Inventory (Fulkerson et al, Int J Behav Nutr Phys Act 2008;5: 55) and the Children's Dietary Questionnaire (Int J Pediatr Obes 2009;08 April)
Timepoint [2] 257098 0
Baseline, and 12 and 24 months following randomisation
Secondary outcome [3] 257099 0
Quality of Life will be assessed using the Peds QL and the Health Utilities Index
Timepoint [3] 257099 0
Baseline, and 12 and 24 months following randomisation
Secondary outcome [4] 257100 0
Psychological functioning will be assessed using the Parenting Scale, and the Strengths and Difficulties questionnaire
Timepoint [4] 257100 0
Baseline, and 12 and 24 months following randomisation

Eligibility
Key inclusion criteria
All children enrolled at local general practices or attending Paediatrics Outpatients will be invited to attend well child screening checks. Only those with BMI values greater than or equal to the 85th percentile (CDC) will be randomised to feedback and intervention conditions.
Minimum age
4 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to participate in a behavioural intervention.
On any medication known to affect body composition or growth.
Not intending to reside in Dunedin for the next two years.

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)
Sealed opaque envelopes containing randomisation group - opened once consent had been obtained to participate
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization to feedback condition occurred using random block lengths (Stata 12.0, StataCorp, College Station, TX) after stratifying for practice
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants and nurses working with the families cannot be blinded to intervention condition because of the nature of the intervention. However, the researchers undertaking all annual outcome measures will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our study has 90% power (P , .05) to detect differences of 0.15 BMI z score units with 73 children in each intervention group (assuming SD of 0.5 and repeated- measures correlation of 0.8). Recruiting 200 children allows for 20% dropout and a design effect of 1.15 to account for sampling of general practices rather than individuals. A mixed model, adjusting for the base- line measure will be used to analyse the data. The model will test for differences between treatments at the two time periods and the analysis will conform to the CONSORT statement for analysing randomised control trials

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
15/03/2010
Date of last participant enrolment
Anticipated
30/05/2011
Actual
14/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1093
Recruitment outside Australia
Country [1] 1936 0
New Zealand
State/province [1] 1936 0

Funding & Sponsors
Funding source category [1] 237460 0
Government body
Name [1] 237460 0
Health Research Council
Country [1] 237460 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medical & Surgical Sciences
University of Otago
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 236946 0
None
Name [1] 236946 0
Address [1] 236946 0
Country [1] 236946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239589 0
Lower South Regional Ethics Committee
Ethics committee address [1] 239589 0
Ethics committee country [1] 239589 0
New Zealand
Date submitted for ethics approval [1] 239589 0
01/09/2009
Approval date [1] 239589 0
22/10/2009
Ethics approval number [1] 239589 0
LRS/09/09/039

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

Contacts
Principal investigator
Name 30015 0
A/Prof Rachael Taylor
Address 30015 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054, New Zealand
Country 30015 0
New Zealand
Phone 30015 0
+64 3 479 0999 extn 8507
Fax 30015 0
Email 30015 0
[email protected]
Contact person for public queries
Name 13262 0
Rachael Taylor
Address 13262 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054, New Zealand
Country 13262 0
New Zealand
Phone 13262 0
+64 3 4795262
Fax 13262 0
Email 13262 0
[email protected]
Contact person for scientific queries
Name 4190 0
Rachael Taylor
Address 4190 0
Department of Medicine, University of Otago, PO Box 56, Dunedin 9054, New Zealand
Country 4190 0
New Zealand
Phone 4190 0
+64 3 479 0999 extn 8507
Fax 4190 0
Email 4190 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
SourceTitleYear of PublicationDOI
EmbaseA tailored family-based obesity intervention: A randomized trial.2015https://dx.doi.org/10.1542/peds.2015-0595
N.B. These documents automatically identified may not have been verified by the study sponsor.