RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol).

INTRODUCTION: Most simple undisplaced fractures can be managed without surgery by immobilising the limb with a splint, prescribing medication for pain, and providing advice and early rehabilitation. Recent systematic reviews based on retrospective observational studies have reported that virtual fracture clinics can deliver follow-up care that is safe and cost-effective. However, no randomised controlled trial has investigated if a virtual fracture clinic can provide non-inferior physical function outcomes compared with an in-person clinic for patients with simple fractures. METHODS AND ANALYSIS: 312 participants will be recruited from 2 metropolitan hospitals located in Sydney, Australia. Adult patients will be eligible if they have an acute simple fracture that can be managed with a removable splint and is deemed appropriate for follow-up at either the virtual or in-person fracture clinic by an orthopaedic doctor. Patients will not be eligible if they have a complex fracture that requires a cast or surgery. Eligible participants will be randomised to receive their follow-up care either at the virtual or the in-person fracture clinic. Participants at the virtual fracture clinic will be reviewed within 5 days of receiving a referral through video calls with a physiotherapist. Participants at the in-person fracture clinic will be reviewed by an orthopaedic doctor within 7-10 days of receiving a referral. The primary outcome will be the patient's function measured using the Patient-Specific Functional Scale at 12 weeks. Secondary outcomes will include health-related quality of life, patient-reported experiences, pain, health cost, healthcare utilisation, medication use, adverse events, emergency department representations and surgery. ETHICS AND DISSEMINATION: The study has been approved by the Sydney Local Health District Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The trial results will be submitted for publication in a reputable international journal and will be presented at professional conferences. TRIAL REGISTRATION NUMBER: ACTRN12623000934640.

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years.

BACKGROUND: Beginning in 2017 we have conducted a 3-arm randomised controlled trial (RCT) to determine the effectiveness of an early obesity intervention in the first two years of life using either telephone or Short Message Service (SMS) support for mothers. The trial recruited 1155 mothers from their third trimester of pregnancy. This protocol is for a new trial to build on the existing trial using the mother-child dyads retained at 24 months for recruitment to the new RCT. The aim of this new trial is to test whether use of a combination of telephone and SMS interventions is effective in promoting healthy eating and physical activity, as well as reducing child body mass index (BMI) at 3 years of age. METHODS: We will conduct a parallel RCT with an estimated sample of 750 mother-child dyads retained from the existing trial at 24 months. Mothers who completed the 24 months survey, including a telephone survey and measurement of child's height and weight will be invited to participate in the new trial. Informed consent will be obtained at the 24 months survey. The participating mother-child dyads will then be randomly allocated to the intervention (combined telephone and text messaging intervention) or the control group. The intervention will comprise three staged telephone consultations and text messages after each of the three intervention booklets is mailed to mothers at specific time-points between two and three years of child age. The main trial outcome measures include a) BMI and BMI z-score measured at 36 months, b) diet, physical activity and screen time c) cost-effectiveness, and d) feasibility and acceptability of the intervention. DISCUSSION: This unique opportunity to link two studies will expedite project start up time, utilise existing research infrastructure and systems to run the study, and optimise the use of an already engaged population of study participants. It can address a significant knowledge gap regarding early obesity prevention for children aged 2 to 3 years. The feasibility and effectiveness of the combined telephone and SMS intervention will indicate whether this is a scaleable, broad-reach and low-cost early obesity intervention. TRIAL REGISTRATION: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12618001571268 ) on 20/09/2018.