Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in … (NCT06616467) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
Mexico144 participantsStarted 2024-09-02
Plain-language summary
Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.
Who can participate
Sex
FEMALE
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:
* Mother-child dyads that are in the postpartum
* mothers who declare that they know how to read and write in spanish
* have an electronic device (cell phone, tablet or computer),
* have an internet connection.
* Have the social network WhatsApp®
* Agree to participate voluntarily evidenced by informed consent will be considered
Exclusion Criteria:
* Women who report having received information about TT one month before the intervention.
* Women who are actively participating in programs related to early stimulation
* Who declare that they have a premature infant born before 37 SDG,
* who has a low birth weight \<2,500g,
* who has a medical condition or complication at birth that impacts their physical mobility and
* who has chronic health problems or congenital anomalies.
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
Increased practice of tummy time in infants
Timeframe: It will be measured at baseline, 3 and 6 months.
2
Maintenance of healthy weight in the infant
Timeframe: It will be measured at baseline, at 3 and 6 months of age of the infant.