- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502979
Learning to Love Mealtime Together (LiTTLe Me)
Enhancing Caregiver-Infant Communication to Prevent Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Once obese as an infant, the relative risk of remaining obese appears to rise with increasing age. Thus, the early years of life have been posited as an important target period for obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental factors, obesity fundamentally reflects an imbalance between energy intake and expenditure. Self-regulation of energy intake aligned with physiologic need is essential to this balance. The process(es) by which infants begin to disassociate eating behavior from physiologic need is unclear, thus it is crucial to better understand predictors of individual differences in self-regulation of energy intake. It is well established that autonomic regulation may support infant behavioral regulation, suggesting that autonomic function may be a critical area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction quality during infancy, and findings reveal that more responsive interactions are associated with more effective autonomic regulation. A chronic mismatch between a caregiver's feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness), is thought to contribute to obesity by undermining the infant's capacity to self-regulate intake; the current proposal will be the first to examine the effects on autonomic regulation. The investigators propose an intervention to enrich the capacity of mother-infant dyads to perform their respective interactive tasks. The investigators plan to teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety, which they will in turn teach their preverbal infant. This training in ASL will be augmented with targeted information for mothers about infants' capacities to self-regulate energy intake in response to hunger and satiety and communicate those states with intention. Mothers also will be taught about expected development of infants' eating behaviors and nutritional requirements to support healthy growth.
Using a two-group randomized repeated measures design, this study aims to 1) evaluate the feasibility and acceptability of the intervention and study methods, including recruitment, enrollment, and data collection (self-report, anthropometrics, video observations, and respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial impact of the intervention on observed feeding interactions, reported infant feeding behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth; and, 3) explore preliminary data on concordance between dyadic feeding interactions and autonomic regulation in both mothers and infants (RSA). In addition to a variety of self-report and anthropometric measures, this study will use integrated behavioral (video) and physiologic (RSA) measures to better understand feeding dynamics and their relationship with obesity risk. Understanding these processes is essential for developing appropriate preventions, or interventions, that will help reduce the prevalence of early childhood obesity and its extension into later childhood and beyond.
Study Phases:
Screening: screening for eligibility and obtaining consent
Study Treatment: study intervention/experimental treatment from baseline visit ([Time 1 (T1)]: age 4-9-months) monthly until 3-months post-baseline ([Time 2 (T2)]: age 7-12-months)
Follow-up: 6-months post-baseline ([Time 3 (T3)]: age 10-15-months)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Parent Inclusion:
- Must be able to read, understand, and speak English or Spanish and be willing to be randomized and participate in data collection.
- Those who are randomized into the experimental group must also be willing to learn ASL specific to communication of hunger, thirst, and fullness.
Infant Inclusion:
- Aged at least 3 months at the time of recruitment
Exclusion Criteria:
Parent Exclusion:
- > 50 years of age
Infant Exclusion:
- Aged more than 9 months at the time of recruitment
- born more than 6 weeks earlier than their estimated due date,
- have any developmental delays or disabilities that make it difficult for them to eat, drink, or communicate,
- attend regular daycare,
- will be younger than 4 months or older than 9 months at the time of the first ASL training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Responsive Feeding
Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls.
The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety.
A video and placemat of mealtime signs will be left with families at the completion of the first visit.
The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables]55], and appropriate portion sizes and variety for healthy growth.
|
Families will receive 4 monthly 1-hour sessions: (1) Signing with infants; (2) infant communication and responsive feeding; (3) nutrition, portion sizes, and neophobia; and, (4) infant intentionality.
|
No Intervention: Routine Care
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant Weight-for-Length Z Scores
Time Frame: 6 Months Post-Baseline (T3)
|
The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale.
The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score.
Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex.
The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex.
A Z-score of 0 is equal to 50th percentile (median).
Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.
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6 Months Post-Baseline (T3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Infant Caloric Intake Compared to Estimated Energy Requirements
Time Frame: 6 Months Post-Baseline (T3)
|
Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements.
Lower values represent greater precision of intake.
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6 Months Post-Baseline (T3)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric Hodges, PhD, FNP-BC, FAAN, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-2437
- R21HD082707 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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