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Learning to Love Mealtime Together (LiTTLe Me)

Primary Purpose

Infant Obesity, Parenting, Feeding Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Responsive Feeding Training
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Obesity focused on measuring Infant Obesity, Parenting, Feeding Behavior, Responsive Feeding

Eligibility Criteria

3 Months - 9 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Responsive Feeding

Routine Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Infant Weight-for-Length Z Scores
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.

Secondary Outcome Measures

Mean Infant Caloric Intake Compared to Estimated Energy Requirements
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.

Full Information

First Posted
July 29, 2020
Last Updated
September 10, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04502979
Brief Title
Learning to Love Mealtime Together
Acronym
LiTTLe Me
Official Title
Enhancing Caregiver-Infant Communication to Prevent Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Infancy is an important target period for obesity prevention because once obese as an infant, the relative risk of remaining obese appears to rise with increasing age at great cost to both individuals and society. The ability to self-regulate energy intake (eating when hungry and stopping when full) is vital to obesity prevention and it is thought that this ability can be derailed by a chronic mismatch between parental feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness). The study will test a novel intervention to help parents and pre-verbal infants better understand one another during feeding and it will offer new insight into how self-regulation of energy intake develops during infancy.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Obesity, Parenting, Feeding Behavior
Keywords
Infant Obesity, Parenting, Feeding Behavior, Responsive Feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Responsive Feeding
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Responsive Feeding Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infant Weight-for-Length Z Scores
Description
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.
Time Frame
6 Months Post-Baseline (T3)
Secondary Outcome Measure Information:
Title
Mean Infant Caloric Intake Compared to Estimated Energy Requirements
Description
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.
Time Frame
6 Months Post-Baseline (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hodges, PhD, FNP-BC, FAAN
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
The investigator proposing to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement.

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Learning to Love Mealtime Together

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