CompletedNot Applicable

Eat Healthy for Families

United States41 participantsStarted 2017-07-01

Plain-language summary

This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.

Who can participate

Age range

2 Years – 5 Years

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: * the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity); * the child is 2-5 years-old with a BMI-for-age and sex \<95th percentile; * the parent and child live together ≥50% of the time; * the parent and child are able to read, speak and understand English; * the family has transportation to the University of Delaware; and * the family is committed to the 6-month program. Exclusion Criteria: * the child is participating in a weight management program or seeing a Registered Dietitian for weight loss; * the child is taking weight loss medication or medication that impacts appetite; or * the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.

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

Dietary Energy Density

Timeframe: 6 months

Energy Intake

Timeframe: 6 months

Dietary Quality

Timeframe: 6 months

Trial details

NCT IDNCT03394326

SponsorUniversity of Delaware

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-09

View on ClinicalTrials.gov More Obesity, Childhood trials

Who can participate

Age range

2 Years – 5 Years

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.