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Can personalized coaching help hispanic kids stay healthy? new trial aims to find out

NCT ID NCT04971044

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a personalized coaching program for low-income Hispanic families with young children (ages 4-6) to prevent obesity. The program helps families overcome daily barriers to healthy eating and physical activity. 301 parent-child pairs will be followed for several years to see if the program improves children's body mass index compared to a standard school readiness program.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multi-level behavioral intervention (personalized coaching and support for healthy eating and activity)
What this could lead to
If successful, this could provide an effective, personalized approach to prevent childhood obesity in high-risk communities, reducing long-term health disparities.
What could go wrong
This is a behavioral intervention study, not a drug trial. Results depend on families' ability to stick with the program, and the effect may be modest or hard to sustain over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

301 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * child with an age ≥4 years and \<7 years; * index parent/legal guardian with an age ≥18 years; * English- or Spanish-speaking; * self-identify as Hispanic/Latino; * live in a home where Spanish is spoken; * include an index parent/legal guardian with a body mass index of ≥25kg/m2 and \<55 kg/m2; * include a child with a body mass index ≥5th percentile percentile for age and gender on standardized CDC growth curves; * for participants intending to attend intervention sessions in person: reside within or frequent (i.e. work in or regularly visit) one of the following zip codes: South Nashville/Regions 1 and 2 (37013, 37204, 37210, 37211, 37217, 37220, 37076, 37086, 37167): surrounding the Coleman Recreation Center and Southeast Recreation Center; and Northeast Nashville/Madison/Region 3 (37115, 37138, 37072, 37207, 37216); for participants intending to attend intervention sessions via videoconference: participants may reside in any zip code; * have parental commitment to participate in a two-year research study; * have consistent mobile phone access; * are without medical conditions necessitating limited physical activity as evaluated by a pre-screen; * complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items; * are considered underserved, measured by parent-self reporting that they or someone in their household are eligible for or participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, and/or Families First (TANF) Child exclusion criteria: * Children outside the specified age range * Children who are \<5th percentile on standardized CDC growth curves * Children who do not speak English or Spanish * Children who are diagnosed with medical illnesses where regular exercise might be contraindicated * Children who display dissenting behaviors during baseline assent or anthropometric data collection * Children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen * Children who are diagnosed with autism Caregiver exclusion criteria include: * Parents/legal guardians who are \<18 years old; * Parents/legal guardians with serious mental or neurologic illness that impairs ability to consent/participate; * Parents/legal guardians with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener). * Parents/legal guardians with BMI \<25kg/m2 or BMI ≥55kg/m2 * Parents/legal guardians who are diagnosed with medical illnesses where regular exercise might be contraindicated * Lack of parental commitment to participate consistently for a two-year period * Lack of telephone contact * Parents/legal guardians who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen

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Conditions

The condition(s) this trial relates to.

Obesity Pediatric Obesity obesity disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.