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Stage 1 treatment of pediatric overweight and obesity: a pilot and feasibility randomized controlled trial.

ABSTRACT: Staged clinical treatment of pediatric obesity is recommended, but untested. Understanding the lowest intensity stage's effectiveness is necessary for future research.This was a randomized controlled trial of children ages 4 to <9 years. Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI ?85th percentile. The intervention was patterned after the "Prevention plus, Stage 1" treatment recommended by an expert committee. Groups were compared for changes, over a 3-month time period, in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat (ITT) analysis.Seventy-two (30% of eligible) children were enrolled and 64 were remeasured at 3-month follow-up. ITT analysis revealed that both groups improved mean BMI z-score [adjusted change -0.07, control, and -0.04, intervention; 95% confidence interval (CI) of difference=-0.14-0.20]. Over half of the children in each group improved their BMI z-score (adjusted proportion decreasing=55% in control vs. 72% in intervention; 95% CI of difference=-0.07-0.42). The intervention group improved comparatively to the control group on numerous behavioral indicators.Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes. Results of this study can be used by future clinical researchers designing protocols to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical settings.

SUBMITTER: Stovitz SD

PROVIDER: S-EPMC3922232 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Stage 1 treatment of pediatric overweight and obesity: a pilot and feasibility randomized controlled trial.

Stovitz Steven D SD Berge Jerica M JM Wetzsteon Rachel J RJ Sherwood Nancy E NE Hannan Peter J PJ Himes John H JH

Childhood obesity (Print) 20140110 1

<h4>Background</h4>Staged clinical treatment of pediatric obesity is recommended, but untested. Understanding the lowest intensity stage's effectiveness is necessary for future research.<h4>Methods</h4>This was a randomized controlled trial of children ages 4 to <9 years. Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI ≥85th percentile. The intervention was patterned after the "Prevention plus, Stage 1" treatment recommended by an expert co ...[more]

PMID: 24410433

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Project description:BackgroundIn order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment.MethodsThis six-month parallel two-arm feasibility trial took place at three pediatric outpatient clinics in Stockholm, Sweden. Participants, 5-12 years, starting obesity treatment were randomized to using an mHealth support system as an addition to standard care (intervention) or to standard care alone (control). The intervention included daily self-monitoring of weight transferred to a mobile application (app) used by parents, a website in which clinicians could track treatment progress, prespecified treatment goals for change in degree of obesity shown in the app and on the website, and text message interactions between clinicians and parents. The main outcome was description of feasibility. Height and weight were measured at baseline, three, and 6 months to explore changes in body mass index standard deviation score (BMI SDS).ResultsOf 40 children eligible for inclusion, 28 agreed to participate (54% girls) and were randomized to intervention (n = 15) or control (n = 13). Weight was measured at home regularly throughout the entire trial period by 12/15 children in the intervention group. Attendance at appointments were better in the intervention group (p = 0.024). Both parents and clinicians had a positive experience and found the mHealth support system accessible. At 6 months the intervention group had a greater reduction of 0.24 units in BMI SDS than standard care (- 0.23 vs. 0.01, p = 0.002).ConclusionsThe mHealth support system was a feasible and innovative treatment approach which, in addition to standard care, generated better treatment results than standard care alone. Future research should evaluate the treatment effects over a longer follow-up time in a larger study sample.Trial registrationThis trial was retrospectively registered at ClinicalTrials.gov , ID: NCT03380598 , on November 8, 2017.

Project description:BackgroundChildren presenting to emergency departments of community hospitals may require transfer to a children's hospital for more definitive care, but the transfer process can be distressing and burdensome to patients, families, and the healthcare system. Using telehealth to bring the children's hospital nurse virtually to the bedside of the child in the emergency department has the potential to promote family-centered care and minimize triage issues and other transfer-associated burdens. To explore the feasibility of the nurse-to-family telehealth intervention, we are conducting a pilot study.MethodsThis parallel cluster randomized controlled feasibility and pilot trial will randomize six community emergency departments to use either nurse-to-family telehealth (intervention) or usual care (control) for pediatric inter-facility transfers. All eligible children presenting to a participating site during the study period who require inter-facility transfer will be included. Eligibility requires that there be an English-speaking adult parent or guardian at the emergency department bedside. We will examine feasibility objectives that assess protocol assignment adherence, fidelity, and survey response rates. We will measure subject-level exploratory outcome data to test feasibility of data collection and to obtain effect size estimates; exploratory outcomes include family-centered care, family experience, parent acute stress, parent distress, and change in level of care. Additionally, we will conduct a mixed methods implementation evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework.DiscussionThe findings from this trial will increase our understanding about nurse-to-family telehealth during pediatric transfers. The mixed methods implementation evaluation will provide relevant insight about the contextual factors that influence the implementation and rigorous evaluation of our intervention.Trial registrationClinicalTrials.gov Identifier: NCT05593900. First Posted: October 26, 2022. Last Update Posted: December 5, 2022.

Project description:BackgroundResuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.MethodsOpen-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.ResultsOf 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%).ConclusionsA pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.

Project description:BackgroundSeptic shock is a low-frequency but high-stakes condition in children requiring prompt resuscitation, which makes it an important target for simulation-based education.ObjectiveIn this study, we aimed to design and implement an augmented reality app (PediSepsisAR) for septic shock simulation, test the feasibility of measuring the timing and volume of fluid administration during septic shock simulation with and without PediSepsisAR, and describe PediSepsisAR as an educational tool. We hypothesized that we could feasibly measure our desired data during the simulation in 90% of the participants in each group. With regard to using PediSepsisAR as an educational tool, we hypothesized that the PediSepsisAR group would report that it enhanced their awareness of simulated patient blood flow and would more rapidly verbalize recognition of abnormal patient status and desired management steps.MethodsWe performed a randomized controlled feasibility trial with a convenience sample of pediatric care providers at a large tertiary care pediatric center. Participants completed a prestudy questionnaire and were randomized to either the PediSepsisAR or control (traditional simulation) arms. We measured the participants' time to administer 20, 40, and 60 cc/kg of intravenous fluids during a septic shock simulation using each modality. In addition, facilitators timed how long participants took to verbalize they had recognized tachycardia, hypotension, or septic shock and desired to initiate the sepsis pathway and administer antibiotics. Participants in the PediSepsisAR arm completed a poststudy questionnaire. We analyzed data using descriptive statistics and a Wilcoxon rank-sum test to compare the median time with event variables between groups.ResultsWe enrolled 50 participants (n=25 in each arm). The timing and volume of fluid administration were captured in all the participants in each group. There was no statistically significant difference regarding time to administration of intravenous fluids between the two groups. Similarly, there was no statistically significant difference between the groups regarding time to verbalized recognition of patient status or desired management steps. Most participants in the PediSepsisAR group reported that PediSepsisAR enhanced their awareness of the patient's perfusion.ConclusionsWe developed an augmented reality app for use in pediatric septic shock simulations and demonstrated the feasibility of measuring the volume and timing of fluid administration during simulation using this modality. In addition, our findings suggest that PediSepsisAR may enhance participants' awareness of abnormal perfusion.

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Stage 1 treatment of pediatric overweight and obesity: a pilot and feasibility randomized controlled trial.

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Stage 1 treatment of pediatric overweight and obesity: a pilot and feasibility randomized controlled trial.

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