Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000711415
Ethics application status
Approved
Date submitted
20/05/2016
Date registered
30/05/2016
Date last updated
26/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Let's Nudge: Pilot randomised trial for a nudge-based obesity intervention in the home for children presenting to paediatricians
Scientific title
Let's Nudge: Pilot randomised trial for a nudge-based obesity intervention in children presenting to paediatricians
Secondary ID [1] 289185 0
Nil known
Universal Trial Number (UTN)
U1111-1182-8934
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 298742 0
Condition category
Condition code
Diet and Nutrition 298788 298788 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standardised paediatrician care and in-home nudge modifications (intervention group):

Standardised paediatrician care will be delivered by community-based general paediatricians trained in the assessment of obesity for the study. Parent(s) and the child will attend a single 45-minute consultation at the child’s usual paediatric practice. The consultation will provide: (1) brief clinical assessment of weight-related health (usually to confirm simple obesity without unusual causes or comorbidities requiring medical management); (2) effective communication about obesity using simple tools understood by families; and (3) additional testing, treatment or referral to a specialist tertiary weight management clinic for the few cases for whom these would be clearly indicated. There will be no cost to families for this consultation. Though unlikely, families will be free to schedule further weight management appointments at the paediatricians' discretion without the involvement of the research team.

The in-home nudge modifications will be delivered in person by a trained research assistant over two home visits. The first visit will assess the home environment and implement the nudges (90 minutes, two researchers), the second (one month later) will refine the nudges (30 minutes, one researcher). Phone support with a trained research assistant will be available for the duration of the intervention.

A ‘nudge’ is any aspect of the decision-making environment that encourages choices that individuals recognise are good for them but which they may nevertheless struggle to make (eg whether or not to have that second slice of cake). It does not restrict their options. In the context of obesity, nudges are about making healthy choices easier. The nudges used in this study are derived from existing methods that have shown some promise in the promotion of health behaviour. Examples include (but are not limited to) smaller tableware to limit overconsumption, cutlery designed to slow eating rate and enhance internal satiety cues, school lunchboxes with compartments specified for healthy foods, and fruit bowls to make healthy foods visible and easily accessible, while less healthy alternatives are out of sight and less easily accessed.

At home visits, the research assistant will recommend a suite of nudges to each family based on (a) their questionnaire information and (b) their home environment. Families will choose which nudges they feel able to implement based on their own situation. As each nudge could have at most a small impact in and of itself, and nudges are expected to be additive, we will encourage families to choose as many suitable nudges as possible. Families will be asked to maintain the nudges for the duration of the trial. Self-reported adherence will be assessed using study-designed questions in the follow-up survey, and we will record whether implemented nudges have been sustained at home visit 2 and the three-month follow up visit. Encouragement will be given at the home visits and in any family-initiated telephone support to improve fidelity.
Intervention code [1] 294721 0
Treatment: Other
Intervention code [2] 294722 0
Lifestyle
Intervention code [3] 294723 0
Behaviour
Comparator / control treatment
Usual care (control group):

Families in the usual care group will not be offered the standardised paediatric care consultation or in-home nudge modifications. Parents will be informed that they are free to seek assistance for obesity from their child’s paediatrician and/or other health services. Should they present to a paediatrician trained for the study, the paediatrician will be able to assess the child's health using skills gained in the training process. Based on our experience in previous obesity trials, we expect very few to do so suggesting that this source of contamination will also be low in this study. Even for those that do, resulting BMI change is unlikely since they will not receive the nudge intervention and a single paediatrician assessment has not be shown to result in relative BMI reduction.
Control group
Active

Outcomes
Primary outcome [1] 298256 0
Acceptability assessed using study-designed questions with parent and paediatrician report.
Timepoint [1] 298256 0
For parents: three and six months after randomisation. For paediatricians: once all children in the intervention group have attended the standardised paediatric care consultation.
Primary outcome [2] 298390 0
Feasibility assessed using study-designed questions with parent and paediatrician report.
Timepoint [2] 298390 0
For parents: three and six months after randomisation. For paediatricians: once all children in the intervention group have attended the standardised paediatric care consultation.
Secondary outcome [1] 323719 0
Body Mass Index (BMI) z-score calculated using age and sex-specific United States Centers for Disease Control (CDC) growth charts. Height assessed using a portable rigid stadiometer. Weight assessed using bioelectrical impedance analysis digital scales.
Timepoint [1] 323719 0
At baseline and at three and six months after randomisation (child only)
Secondary outcome [2] 323766 0
Waist circumference assessed using steel pocket tape measure.
Timepoint [2] 323766 0
At baseline and at three and six months after randomisation (child only).
Secondary outcome [3] 323767 0
Body fat percentage assessed using bioelectrical impedance analysis digital scales.
Timepoint [3] 323767 0
At baseline and at three and six months after randomisation (child only).
Secondary outcome [4] 323773 0
Blood pressure assessed using digital blood pressure device.
Timepoint [4] 323773 0
At three months after randomisation (child only).
Secondary outcome [5] 323774 0
Physical activity and sedentary behaviour assessed using a digital accelerometer worn on the wrist for 7 full days. This will measure mean activity counts per minute as well as the percentage of time spent in sedentary, light, moderate and vigorous activity.
Timepoint [5] 323774 0
At baseline and at three and six months after randomisation (child only).
Secondary outcome [6] 323775 0
Health-related quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 with parent-proxy report for all ages and child self-report for 5-11 year olds.
Timepoint [6] 323775 0
At baseline (parent-proxy report) and at three months after randomisation (child self-report and parent-proxy report).
Secondary outcome [7] 323777 0
Parent-reported child dietary intake assessed using the ASA24 for families in the intervention and control group.
Timepoint [7] 323777 0
Assessed at three and six months after randomisation.
Secondary outcome [8] 323778 0
Self-reported child body satisfaction assessed using the Children's Body Image Scale (CBIS) for 8-11 year olds.
Timepoint [8] 323778 0
Assessed at three after randomisation.
Secondary outcome [9] 323779 0
Self-reported child physical appearance and self worth assessed using a modified version of Harter's Perceived Competence Scale for 5-11 year olds.
Timepoint [9] 323779 0
At three months after randomisation.
Secondary outcome [10] 323780 0
Parent mental health assessed using the Kessler-6 (K6).
Timepoint [10] 323780 0
At baseline and at three months after randomisation.
Secondary outcome [11] 323781 0
Obesogenic home environment assessed using the Family Nutrition and Physical Activity (FNPA) screening tool with parent report.
Timepoint [11] 323781 0
At baseline and at three months after randomisation.
Secondary outcome [12] 323782 0
Study-designed questions assessing help-seeking to manage child's weight, child activity levels and a range of potential confounders with parent report.
Timepoint [12] 323782 0
At baseline and at three and six months after randomisation.
Secondary outcome [13] 323783 0
Study-designed questions assessing paediatrician competence and confidence to assess childhood obesity and related comorbidities.
Timepoint [13] 323783 0
At baseline and and once all children in the intervention group have been seen.

Eligibility
Key inclusion criteria
Children presenting to the participating paediatric practice or children whose parents initiated contact with us about the study who are aged between 3–12 years old (up to but not including their 13th birthday) and identified as obese according to CDC charts (ie BMI greater than or equal to the 95th age- and sex-specific percentile), and their families.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded from the study if they:
1. have a major disability or health condition judged by parents, paediatricians and/or researchers to preclude participation (eg severe autism),
2. or are receiving treatment from a tertiary weight management service.

Finally, families who do not speak sufficient English to participate meaningfully in the trial will also be excluded, as we do not have the funds available for interpreters.

Recognised health conditions or medications likely to have an impact on weight will be recorded in the study database and participants meeting these criteria will be excluded from secondary analyses.

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)
Eligibility will be determined by a trained research assistant during a screening session at the participating paediatric practice or at a screening home visit for those recruited externally to the participating paediatric practice (inclusion criteria) and a subsequent follow-up call (exclusion criteria). Eligible and interested families will be sent an enrolment pack with a consent form and baseline survey. Upon receipt of the completed consent form and survey, participants will be automatically allocated to groups when their details are entered into the REDCap database used for the study. Allocation concealment will be achieved by randomisation using a concealed allocation sequence in REDCap stratified by child gender and pre-generated by the Clinical Epidemiology and Biostatistics Unit at the Murdoch Childrens Research Institute. The allocation sequence will be uploaded to an otherwise inaccessible section of the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A concealed computerised randomisation schedule using block randomisation stratified by child gender will be pre-generated by the Clinical Epidemiology and Biostatistics Unit at the Murdoch Childrens Research Institute and uploaded to an otherwise inaccessible section of the REDCap database used for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit a sample of 20 children, A power calculation was not conducted as this is a pilot trial to examine feasibility and acceptability. Instead, this sample size is informed by our previous experience conducting obesity intervention studies and allows for computation of 95% confidence intervals for the median of continuous outcome measures (eg change in BMI z-score) without requiring normal distribution assumptions (ie non-parametric confidence intervals).

The statistical methods used will inform sample sizes and inclusion criteria for a subsequent trial assessing efficacy. Screening and recruitment rates will be reported. Sample characteristics of potential outcome variables and covariates will be described, using mean, range, standard deviation and distribution quantiles. Parent report of the acceptability of the intervention will be presented, as will barriers to paediatrician consultation attendance and uptake of specific home modifications. Individual changes in obesity measures will be calculated and reported for each group using measures of central tendency (eg mean, medians with 95% confidence intervals) and data dispersion (eg standard deviation, interquartile range), and effect sizes will be established.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/07/2016
Actual
21/03/2017
Date of last participant enrolment
Anticipated
16/10/2016
Actual
22/06/2017
Date of last data collection
Anticipated
Actual
13/12/2017
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293593 0
Charities/Societies/Foundations
Name [1] 293593 0
The Ian Potter Foundation
Country [1] 293593 0
Australia
Funding source category [2] 293594 0
Charities/Societies/Foundations
Name [2] 293594 0
The Limb Family Foundation
Country [2] 293594 0
Australia
Funding source category [3] 299336 0
Charities/Societies/Foundations
Name [3] 299336 0
The Royal Children's Hospital Foundation
Country [3] 299336 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 292409 0
None
Name [1] 292409 0
Address [1] 292409 0
Country [1] 292409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295034 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 295034 0
Ethics committee country [1] 295034 0
Australia
Date submitted for ethics approval [1] 295034 0
11/05/2016
Approval date [1] 295034 0
22/07/2016
Ethics approval number [1] 295034 0
36111A

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

Contacts
Principal investigator
Name 65782 0
Prof Melissa Wake
Address 65782 0
Centre for Community Child Health
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Country 65782 0
Australia
Phone 65782 0
+61 3 9345 5761
Fax 65782 0
Email 65782 0
[email protected]
Contact person for public queries
Name 65783 0
Jessica Kerr
Address 65783 0
Community Health Services Research
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Country 65783 0
Australia
Phone 65783 0
+61 3 9936 6665
Fax 65783 0
Email 65783 0
[email protected]
Contact person for scientific queries
Name 65784 0
Melissa Wake
Address 65784 0
Centre for Community Child Health
Murdoch Childrens Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Country 65784 0
Australia
Phone 65784 0
+61 3 9345 5761
Fax 65784 0
Email 65784 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.