CompletedNot Applicable

Energy Regulation and Nutritional Status of Children: A Satiation Study

Ghana41 participantsStarted 2022-05-02

Plain-language summary

This is study among children attending child welfare clinics in Greater Accra Region of Ghana. The investigators want to find out if moderately malnourished children regulate the food energy intake similarly to healthy children, using an established method to assess energy compensation.

Who can participate

Age range

12 Months – 36 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: * moderately malnourished (WHZ between -3 and -2 Z-scores) or stunted (HAZ\<-2SD) or Healthy (WHZ \>-2SD and HAZ \>-2SD) children age 12-36 months. * Children should be attending child welfare clinics at the selected communities. * The children should be accompanied by a main caregiver who is actively involved in cooking for and/or feeding the child. * Children who are able to fast for at least 2 hours prior to the experiment. Exclusion Criteria: * Children with congenital disorders, disabilities and diseases requiring specialised care and hospitalisation. * Children with severe malnutrition with complications that required inpatient care. * Tube-fed children. * Children who are both stunted and moderately malnourished

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

Compensation index (Compx)

Timeframe: calculated on second visit (1-4 weeks after first visit) after consumption of second test meal

Trial details

NCT IDNCT05346549

SponsorUniversity of Ghana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Underweight trials

Who can participate

Age range

12 Months – 36 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.