Sleep & Nutrition Education for Childhood Obesity
Recruiting in Palo Alto (17 mi)
Overseen byMegan J Gray, MD,MPH,FAAP
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas at Austin
Disqualifiers: Mother smokes, works nights, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of the study is to understand how mothers think and feel about feeding their babies and putting them to sleep, understand more about programs that can support mothers taking care of babies, and how professionals can be most helpful in helping mothers make decisions about their baby's feeding and sleeping. The overarching goal is to prevent early life obesity and progression to metabolic syndrome in high-risk populations, starting with healthy toddler weights by age 2 years.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Bright by Text, Centering Parenting for childhood obesity?
Research shows that promoting good sleep habits in family-based programs can help reduce childhood obesity. Educating parents about sleep routines and limiting screen time are common strategies that have been used in similar interventions.
12345Is the Sleep & Nutrition Education for Childhood Obesity treatment safe for children?
The interventions that include sleep promotion for childhood obesity, such as educating parents on sleep hygiene and bedtime routines, have been implemented safely in various settings like clinics and homes. These interventions are generally considered safe for children, as they focus on improving sleep habits and overall health.
16789How does the Sleep & Nutrition Education treatment for childhood obesity differ from other treatments?
This treatment is unique because it focuses on improving sleep quality and quantity as a way to prevent childhood obesity, which is not commonly emphasized in other interventions. While most existing treatments target diet and physical activity, this approach highlights the role of sleep education and bedtime routines, making it a novel addition to obesity prevention strategies.
1371011Eligibility Criteria
This trial is for Hispanic mothers over 18 with healthy, full-term infants under one month old who are patients of CommUnityCare. It's not for those who smoke, work mainly at night, or have babies with metabolic/chromosomal disorders, chronic neurological/respiratory conditions, or developmental disabilities.Inclusion Criteria
My baby was born full term and is younger than 1 month.
The mother is of Latino/Hispanic ethnicity.
I am a mother and I am 18 years old or older.
+4 more
Exclusion Criteria
The mother's primary work schedule is during the night.
The baby has certain medical conditions or disabilities.
The participant's mother is a smoker.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive community-embedded coaching on responsive feeding and sleep practices through group visits and text-based programs
22-24 months
8 group sessions, regular well-child checks
Follow-up
Participants are monitored for impact on infant feeding practices and sleep quality
2-4 months
Participant Groups
Project Sueño aims to prevent early obesity and metabolic syndrome by studying how support programs like Bright by Text and Centering Parenting can help mothers make better decisions about their baby's feeding and sleeping habits.
3Treatment groups
Experimental Treatment
Active Control
Group I: Group A: Centering ParentingExperimental Treatment1 Intervention
At each well-child check from 2- to 24-months, a trained bilingual facilitator from the CommUnityCare Centering Parenting program will present curriculum in person during 2-hour visits in a room with 3-8 mother-baby pairs per group. During each session, each mother-baby pair will be pulled out to a private medical room for a brief individual well child appointment with the pediatrician. During this appointment, infant measurements, physical exam, and discussion of unique concerns will take place before the pair returns to the session. There are 8 scheduled well child checks by the age of two, where regular parenting topics will be covered (i.e. discipline, safety, co-parenting, sibling relationships, childcare, development). Each Centering session is expected to last approximately 2 hours, for a total commitment of approximately 16 hours across 8 group sessions over the course of 22 months for each participant. Total time of enrollment should be approximately 22-24 months.
Group II: Group B: Bright by TextActive Control1 Intervention
This group will receive standard of care individual well child checks with their regular CommUnityCare pediatrician, with standard anticipatory guidance on feeding and sleep. Additionally, this group will be enrolled in a text-based parenting coaching program. The Bright by Text program will provide parenting tips two to three times weekly; tailored through community partner United Way of Central Texas offering local parent support and resources. The Bright by Text program is a message subscription program rather than an application. Participants may decide on their own how much to engage with the text-based program, so total time commitment cannot be estimated. Total time of enrollment should be approximately 22-24 months.
Group III: Group C: Standard of CareActive Control1 Intervention
This group will receive standard of care individual well child checks with their regular pediatrician, with standard anticipatory guidance on feeding and sleep. Total time of enrollment should be approximately 22-24 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CommUnity Care: North Central Health CenterAustin, TX
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Who Is Running the Clinical Trial?
University of Texas at AustinLead Sponsor
American Diabetes AssociationCollaborator
References
Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. [2020]Sleep promotion in childhood may reduce the risk of obesity, but little is known of its inclusion in family-based interventions. This study examines the proportion and context of family-based interventions to prevent childhood obesity that promote child sleep. We drew on data from a recent systematic review and content analysis of family-based interventions for childhood obesity prevention published between 2008 and 2015, coupled with new data on sleep promotion strategies, designs, and measures. Out of 119 eligible family-based interventions to prevent childhood obesity, 24 (20%) promoted child sleep. In contrast, 106 (89%) interventions targeted diet, 97 (82%) targeted physical activity, and 63 (53%) targeted media use in children. Most interventions that promoted sleep were implemented in clinics (50%) and home-based settings (38%), conducted in the United States (57%), and included children 2-5 years of age (75%). While most interventions utilized a randomized controlled design (70%), only two examined the promotion of sleep independent of other energy-balance behaviors in a separate study arm. Sleep was predominately promoted by educating parents on sleep hygiene (e.g., age-appropriate sleep duration), followed by instructing parents on responsive feeding practices and limiting media use. One intervention promoted sleep by way of physical activity. A large number promoted sleep by way of bedtime routines. Most interventions measured children's sleep by parent report. Results demonstrate that sleep promotion is underrepresented and variable in family-based childhood obesity interventions. While opportunities exist for increasing its integration, researchers should consider harmonizing and being more explicit about their approach to sleep promotion.
Associations of Sleep-Related Outcomes with Behavioral and Emotional Functioning in Children with Overweight/Obesity. [2022]To evaluate the associations of parent-reported sleep-disordered breathing (SDB) and device-assessed sleep behaviors with behavioral and emotional functioning in pediatric patients with overweight/obesity.
Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. [2021]The respective contribution of total, daytime and nighttime sleep duration in childhood obesity remains unclear.
The association between sleep duration and weight in treatment-seeking preschoolers with obesity. [2021]To examine the association between nocturnal sleep duration and weight and caloric intake outcomes among preschool-aged children who are obese and enrolled in a family-based weight management program.
Impact of Childhood Obesity and Psychological Factors on Sleep. [2021]The aim of the study was to analyze sleep duration and behaviors in relation to psychological parameters in children and adolescents with obesity seeking inpatient weight-loss treatment in comparison to normal-weight children, and whether or not these variables would improve during the time course of treatment. Sixty children or adolescents with overweight and obesity (OBE) and 27 normal-weight (NW) peers (age: 9-17) were assessed for subjective sleep measures through self-reported and parent-reported questionnaires, as well as body weight, body composition, and psychological questionnaires. The OBE participants were assessed upon admission and before discharge of an inpatient multidisciplinary weight-loss program. NW participants' data were collected for cross-sectional comparison. In comparison to NW, children and adolescents with OBE had a shorter self-reported sleep duration and had poorer sleep behaviors and more sleep-disordered breathing as reported by their parents. No change in sleep measures occurred during the inpatient treatment. Psychological factors including higher anxiety, depression, and destructive-anger-related emotion regulation were moderate predictors for unfavorable sleep outcomes, independent of weight status. Children with obesity had less favorable sleep patterns, and psychological factors influenced sleep in children, independent of weight. More research is needed on the relationship and direction of influence between sleep, psychological factors, and obesity, and whether they can be integrated in the prevention and management of childhood obesity and possibly also other pediatric diseases.
INSIGHT Responsive Parenting Intervention and Infant Sleep. [2022]Inadequate sleep during infancy is associated with adverse outcomes for infants and families. We sought to improve sleep behaviors and duration through a responsive parenting (RP) intervention designed for obesity prevention.
Overnight sleep duration and obesity in 2-5 year-old American Indian children. [2022]Sleep has emerged as a potentially modifiable risk factor for obesity in children.
Sleep differences in one-year-old children were related to obesity risks based on their parents' weight according to baseline longitudinal study data. [2017]Parental obesity is the predominant risk factor for child obesity. We compared sleep in one-year-old children with different obesity risks, based on parental weight, and explored associations with weight, parental sleep and family factors.
Early childhood obesity prevention in low-income, urban communities. [2023]Given the disproportionately high rates of obesity-related morbidity among low-income, ethnic minority youth, obesity prevention in this population is critical. Prior efforts to curb childhood obesity have had limited public health impact. The present study evaluates an innovative approach to obesity prevention by promoting foundational parenting and child behavioral regulation. This pre-post intervention study evaluated an enhanced version of ParentCorps with 91 families of pre-Kindergarten students in low-income, urban communities. Assessments included tests of knowledge and parent report. Consistent with findings from two randomized controlled trials of ParentCorps, parent knowledge and use of foundational parenting practices increased and child behavior problems decreased. Child nutrition knowledge and physical activity increased and television watching decreased; for boys, sleep problems decreased. Comparable benefits occurred for children at high risk for obesity based on child dysregulation, child overweight, and parent overweight. Results support a "whole child," family-centered approach to health promotion in early childhood.
Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. [2022]This article summarizes a presentation made in February 2017 as part of the National Academy of Sciences' Roundtable on Obesity Solutions webinar, "The Potential Role of Sleep in Obesity Prevention and Management: A Virtual Workshop." Briefly described are the patterns of childhood sleep duration in the United States, the state of the science relating insufficient sleep to overweight and obesity in infancy and early childhood, and the potential mechanisms for the association. Also discussed are intervention efforts to date. Despite research gaps, interventions aimed at increasing sleep quality and quantity may help prevent childhood obesity.
The association between parent education level, oral health, and oral-related sleep disturbance. An observational crosssectional study. [2023]To explore the relationship between parents' education levels, children obesity, children oral health and oral-related sleep disorders.