Learning to Love Mealtime Together

NCT04502979 | Completed Results

• 2 other identifiers: 15-2437R21HD082707
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Obesity; Parenting; Feeding Behavior

Keywords

Infant Obesity; Parenting; Feeding Behavior; Responsive Feeding

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months Post-Baseline (T3)

Secondary Outcomes (1)

• Mean Infant Caloric Intake Compared to Estimated Energy Requirements

  6 Months Post-Baseline (T3)

Study Arms (2)

Responsive Feeding

EXPERIMENTAL

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.

Behavioral: Responsive Feeding Training

Routine Care

NO INTERVENTION

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.

Interventions

Responsive Feeding Training 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.

Responsive Feeding

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Aged at least 3 months at the time of recruitment

You may not qualify if:

• \> 50 years of age
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Results Point of Contact

• Title: Eric A Hodges, PhD, FNC-BC, FAAN
• Organization: University of North Carolina at Chapel Hill

eahodges@email.unc.edu

919-966-0534

Study Officials

• Eric Hodges, PhD, FNP-BC, FAAN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: September 26, 2017
• Primary Completion: April 11, 2019
• Study Completion: April 25, 2019
• Last Updated: September 11, 2020
• Results First Posted: September 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)