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Let's Nudge: Pilot randomised trial for a nudge-based obesity intervention in the home for children presenting to paediatricians

Let's Nudge: Pilot randomised trial for a nudge-based obesity intervention in children presenting to paediatricians

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000711415
Enrollment
15
Registered
2016-05-30
Start date
2017-03-21
Completion date
2017-06-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this pilot randomised controlled trial is to determine the acceptability and feasibility of a novel approach to the treatment of childhood obesity. The approach has two components: 1) an assessment of obese 3-12 year old children's weight-related health by a trained paediatrician, and 2) an in-home intervention where the research team will work with these children's families to make a series of small 'nudge' modifications to the home environment that encourage healthier decision making (eg replacing plates with smaller versions to counter unintentional overconsumption). We hypothesise that the approach will be acceptable to children, parents and paediatricians and feasible to deliver. If so, this pilot study will inform the development of a larger trial designed to test whether the approach is effective.

Interventions

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 comorbiditie

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.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026