The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project (NCT00359242) | Clinical Trial Compass
CompletedPhase 1
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
United States160 participantsStarted 2006-06
Plain-language summary
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Who can participate
Age range
1 Day – 12 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:
* \> 34 0/7 weeks gestational age
* Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
* Singleton infant
* Nursery or NICU stay of 7 days or less
* Primiparous mother
* Maternity stay of 7 days or less
* Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
* Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
* English speaking mother.
Exclusion Criteria:
* Newborn nursery, NICU, or maternity stay \> 7 days
* Exclusive formula feeding in the nursery or NICU
* Multiparous mother
* Any metabolic condition that requires feedings at precise intervals
* Gestational age of 33 6/7 weeks or less
* Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
* Non-singleton newborn
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
1
Percent of infants sleeping 5 consecutive hours at night at 2 months of age