Infant ObesityLiTTLe MeNCT04502979
Learning to Love Mealtime Together
A study testing Responsive Feeding Training in people with Infant Obesity and Parenting, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 months
- Conditions the study is for
- Infant Obesity, Parenting, Feeding Behavior
- What is being tested?
- Responsive Feeding Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Enhancing Caregiver-Infant Communication to Prevent Obesity
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.
Read the 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
- Being tested
- Responsive Feeding Training
- Keywords
- Infant Obesity, Parenting, Feeding Behavior, Responsive Feeding
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive Feeding TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months Post-Baseline (T3)
Secondary outcomes (1)
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.
Measured: 6 Months Post-Baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start26 Sep 2017
- Primary completion11 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Eric Hodges, PhD, FNP-BC, FAAN, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502979
- Sponsor's protocol ID
- 15-2437
- Other IDs
- R21HD082707
- Acronym
- LiTTLe Me
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 11 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Caregiver-Infant Communication to Prevent Obesity
- ClinicalTrials.gov ID
- NCT04502979
- Acronym / sponsor ID
- LiTTLe Me / 15-2437
- Conditions
- Infant Obesity, Parenting, Feeding Behavior
- Keywords
- Infant Obesity, Parenting, Feeding Behavior, Responsive Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 11 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responsive Feeding | Experimental | Behavioral: Responsive Feeding TrainingIntervention 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. |
| 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. |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- > 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Responsive Feeding TrainingFamilies 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. | Behavioural | Responsive Feeding |
Primary outcome
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.
1 secondary outcome
Mean Infant Caloric Intake Compared to Estimated Energy Requirements
Time frame: 6 Months Post-Baseline (T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hodges, PhD, FNP-BC, FAAN principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsive Feeding Training in people with Infant Obesity and Parenting, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Weight-for-Length Z Scores (time frame: 6 Months Post-Baseline (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.