Learning to Love Mealtime Together

NCT ID: NCT04502979

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2019-04-25

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)

Conditions

Infant Obesity; Parenting; Feeding Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Responsive Feeding Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Responsive Feeding Training

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hodges, PhD, FNP-BC, FAAN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21HD082707

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-2437

Identifier Type: -

Identifier Source: org_study_id