Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers (NCT01938118) | Clinical Trial Compass
CompletedNot Applicable
Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
United States430 participantsStarted 2013-10
Plain-language summary
The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a multi-component home visitation program, compared to an attention control (child safety) in promoting appropriate weight gain during infancy.
Who can participate
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:
* Self identifies as non-Hispanic, African-American
* Less than 28 weeks pregnant at time of screening and recruitment
* Expecting a singleton birth
* Maternal age at time of birth will be at 18-39 years
* Lives within specified distance of study site
* Not intending to leave study area before expectant child's 15th month of life
* Agreeable to referring another family member/caregiver to participate in the study
Exclusion Criteria:
* Pre-term birth (\<= 36 weeks gestation)
* Less than 18 years at time of delivery
* Delivers infant with a congenital anomaly or medical condition that significantly affects feeding (e.g., cleft lip and/or palate, metabolic disease)
* Delivers multiples
* Newborn nursery, neonatal intensive care unit (NICU), or maternity floor stay for 7 or more days after the delivery
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
Mean weight-for-length z-score at 15 months of age