The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial.

Pregnant individuals rarely achieve moderate-to-vigorous intensity physical activity recommendations.Purpose The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial aimed to demonstrate feasibility, acceptability, and initial efficacy of a lower intensity intervention targeting reduced sedentary behavior and increased standing and steps.Methods First trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control. Intervention components included biweekly remote health coaching, wearable activity monitor, height-adjustable workstation, and a private Facebook group. Evidence-based behavioral targets included sedentary time < 9 h/day, increasing standing by 2-3 h/day, and ≥ 7500 steps/day. Participants completed all-remote assessments (baseline, second trimester, third trimester) of sedentary behavior and activity (thigh-worn activPAL) along with exploratory pregnancy health outcomes abstracted from medical records. Intervention effects vs. control were evaluated using generalized mixed models and an intention-to-treat approach. Intervention participants also provided feedback on perceived benefits and acceptability.Results Participants (34 intervention; 17 control) had mean age 32 years, were 83% White, with mean pre-pregnancy BMI 28 kg/m2. Retention was high (90% and 83% at second and third trimester follow-up visits). Intervention participants decreased sedentary time (-0.84 h/day, p = 0.019) and increased standing (+0.77 h/day, p = 0.003), but did not increase steps/day (+710, p = 0.257) compared to controls. Intervention participants reported many perceived benefits and identified the wearable, height-adjustable workstation, and behavioral lessons as most useful.Conclusion For pregnant individuals at risk for high sedentary behavior and APOs, a sedentary behavior reduction intervention is feasible, acceptable, and may offer a viable alternative to more intense physical activity recommendations during pregnancy. Further testing in a fully powered clinical trial is warranted.Trial registration NCT05093842 on clinicaltrials.gov.

Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial.

BACKGROUND: Adverse pregnancy outcomes (APOs) identify cardiovascular disease risk, but few effective interventions are available. High sedentary behavior (SED) has recently been associated with APOs, but very few randomized controlled trials (RCTs) have tested SED reduction in pregnancy. OBJECTIVE: The Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) pilot and feasibility RCT addresses this gap by testing the feasibility, acceptability, and preliminary pregnancy health effects of an intervention to reduce SED in pregnant women. The objective of this manuscript is to describe the rationale and design of SPRING. METHODS: Pregnant participants (n=53) in their first trimester, who are at risk for high SED and APO and without contraindications, are randomized in a 2:1 ratio to an intervention or control group. SED (primary outcome) and standing durations, and steps per day, are measured objectively in each trimester for 1 week with a thigh-mounted activPAL3 accelerometer. SPRING also seeks to demonstrate feasibility and acceptability while estimating preliminary effects on maternal-fetal health outcomes assessed during study visits and abstracted from medical records. The pregnancy-customized intervention promotes daily behavioral targets of less than 9 hours of SED and at least 7500 steps, achieved via increased standing and incorporating light-intensity movement breaks each hour. The multicomponent intervention provides a height-adjustable workstation, a wearable activity monitor, behavioral counseling every 2 weeks (through videoconference), and membership in a private social media group. Herein, we review the rationale, describe recruitment and screening processes, and detail the intervention, assessment protocols, and planned statistical analyses. RESULTS: This study was funded by the American Heart Association (20TPA3549099), with a funding period of January 1, 2021, and until December 31, 2023. Institutional review board approval was obtained on February 24, 2021. Participants were randomized between October 2021 and September 2022, with final data collection planned for May 2023. Analyses and submission of results are expected for winter of 2023. CONCLUSIONS: The SPRING RCT will provide initial evidence on the feasibility and acceptability of an SED-reduction intervention to decrease SED in pregnant women. These data will inform the design of a large clinical trial testing SED reduction as a strategy to reduce APO risk. TRIAL REGISTRATION: ClincialTrials.gov NCT05093842; https://clinicaltrials.gov/ct2/show/NCT05093842. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48228.

How effective is LENA in detecting speech vocalizations and language produced by children and adolescents with ASD in different contexts?

The LENA system was designed and validated to provide information about the language environment in children 0 to 4 years of age and its use has been expanded to populations with a number of communication profiles. Its utility in children 5 years of age and older is not yet known. The present study used acoustic data from two samples of children with autism spectrum disorders (ASD) to evaluate the reliability of LENA automated analyses for detecting speech utterances in older, school age children, and adolescents with ASD, in clinic and home environments. Participants between 5 and 18 years old who were minimally verbal (study 1) or had a range of verbal abilities (study 2) completed standardized assessments in the clinic (study 1 and 2) and in the home (study 2) while speech was recorded from a LENA device. We compared LENA segment labels with manual ground truth coding by human transcribers using two different methods. We found that the automated LENA algorithms were not successful (<50% reliable) in detecting vocalizations from older children and adolescents with ASD, and that the proportion of speaker misclassifications by the automated system increased significantly with the target-child's age. The findings in children and adolescents with ASD suggest possibly misleading results when expanding the use of LENA beyond the age ranges for which it was developed and highlight the need to develop novel automated methods that are more appropriate for older children. Autism Research 2019, 12: 628-635. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Current commercially available speech detection algorithms (LENA system) were previously validated in toddlers and children up to 48 months of age, and it is not known whether they are reliable in older children and adolescents. Our data suggest that LENA does not adequately capture speech in school age children and adolescents with autism and highlights the need to develop new automated methods for older children.