CompletedNot Applicable

Learning to Love Mealtime Together

United States71 participantsStarted 2017-09-26

Plain-language 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.

Who can participate

Age range

3 Months – 9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infant Weight-for-Length Z Scores

Timeframe: 6 Months Post-Baseline (T3)

Trial details

NCT IDNCT04502979

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-11

Results submitted2020-08-26

View on ClinicalTrials.gov More Infant Obesity trials