Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention (NCT04042467) | Clinical Trial Compass
CompletedNot Applicable
Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention
United States900 participantsStarted 2019-11-06
Plain-language summary
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.
Who can participate
Age range
21 Days
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
. an English- or Spanish-speaking parent/legal guardian,
. infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life),
. attendance at first newborn clinic visit
. no plans to leave the clinic within 2 years
. Completion of baseline data collection (survey data, child weight and length measures prior to randomization).
. Own a smartphone with access to data services
Exclusion criteria
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.
. born prior to 34 weeks gestation or birth weight \<1500 grams; weight \<3rd %tile at enrollment (World Health Organization growth curves); or
. any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).
. \<18 years old;
. serious mental or neurologic illness that impairs ability to consent/participate;
. poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).