About this trial
The goal of this clinical trial is to determine feasibility and acceptability of a digitally-based obesity prevention intervention for mothers of infants participating in a home visitation program.
The main questions it aims to answer are:
* What impact does the digitally based obesity prevention intervention for parents have on children's weight? * What impact does the digitally based obesity prevention intervention have on mothers' feeding practices, child sleep, and child screen time? Researchers will compare the digital intervention to home visiting standard curriculum to see if the intervention results in larger improvements.
Participants will view several digital modules including videos on feeding, activity and family topics over the course of 1 year. They will complete questionnaires at the beginning of the study and again at 4, 6 and 12 months and their child will be weighed and measured at each time point.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Enrolled in or eligible for home visiting program
Ages 16 years or older
Speaks and reads English
Has no chronic health condition affecting growth or development
Disqualifiers
Child has a major malformation
Child admitted to the NICU
Child considered small for gestation age (SGA) and/or have a low birth weight (<2500 gms)
Mother has a significant maternal morbidity (e.g. cancer) or hospitalization for psychiatric disorder in past 6 months
Trial design
Parallel
Treatments tested in this trial
digital intervention + home visiting curriculum
BehavioralDigitally delivered childhood obesity prevention intervention for parents called THRIVES (Teaching Healthy Routines in Very Early Stages) will be provided to complement the standard home visiting curriculum. Parents will complete digital content containing videos, text and checkpoint questions with goal setting during the first year of their child's life over a 12 month period. Assessments will be collected at baseline, 4, 6 and 12 months.
Home visiting curriculum
BehavioralParents will receive a standard home visiting curriculum delivered in person for at least 1 year during the project timeframe and complete assessments at baseline, 4, 6 and 12 months.
Treatment groups
Trial outcomes
Primary outcomes
Child Weight for Length
Weight for Length (WFL) z-score. A z-score of 0 indicates a child is a the median for WFL. Scores above 0 indicate that a child has a higher WFL and may be at risk for overweight or obesity. Scores below 0 indicate that a child has a lower WFL and may be at risk for undernutrition.
Secondary outcomes
Structure and Control in Parent Feeding Questionnaire (SCFQ)
The SCFQ contains questions related to structure and controlling parental feeding practices. The validated questionnaire has two subscales: 1) Structure (meal routines, feeding environment, etc.) and 2) Control (pressure to eat, restriction, etc.). Responses are captured on a 5-point Likert scale with 1 indicating "never" and 5 indicating "always." Higher scores indicate greater structure or control while lower scores indicate lower structure or control.
Baby's Basic Needs Questionnaire (BBNQ)
Feeding to soothe practices will be captured using the BBNQ which assesses infant's feeding history and extent to which mothers use feeding to soothe their infants. Responses are captured on a 5-point Likert scale (1=Never; 5=Always). Higher scores indicate more frequent use of feeding to soothe while lower scores indicate less use of feeding to soothe.
Feeding behaviors of parents (breastfeeding, timing of juice and solid food introduction)
Questions were adapted from the Beverage Intake Questionnaire, Preschool Version (BEVQ-PS), an instrument designed to assess the frequency of preschool children's intake of beverages, including 100% fruit juice. In the BEVQ-PS, parents report how often their child consumes specific beverages using responses options ranging from "Never" to "3 or more times per day." Higher responses indicate more frequent intake and lower responses indicate less frequent intake. Other measures were adapted from the National Survey of Children's Health (NSCH) questionnaire, which includes standardized items assessing infant feeding practices. Parents report the age at which their child was first given food other than breastmilk or formula or juice, using response options as follows: \<1 month, 2-3 months, 4-5 months, 6-8 months, 9-11 months, or 12 months or older. Responses will be compared to current solid food and juice guidance.
Parental obesity prevention knowledge, attitudes, and behaviors
Checkpoint questions associated with digital intervention module topics will administered after parents complete the digital modules. These items evaluate parents' knowledge, attitudes, and intentions related to obesity-prevention behaviors, including feeding, sleep, screen time, and soothing practices. The questions are not part of a validated scale; responses are summarized descriptively based on accuracy of answers and qualitatively.
Sponsors and contacts
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University of Florida
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator