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Pediatric ObesityNCT03111264

Building Blocks for Healthy Preschoolers

A study testing CHAMP and CHAMP+ in people with Pediatric Obesity, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
What is being tested?
CHAMP and CHAMP+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,943 participants
Where
1 siteUnited States
Study dates
17 Jun 2016to 13 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Preschooler 30-54 months
  • Caregiver and childcare staff must be at least 18 years old
  • Childcare center staff members willing to participate
  • Licensed childcare centers serving low-income communities
  • Children attending participating childcare centers (at least 3 days per week)

Who cannot join

  • Caregivers and staff who do not speak or read English
  • Childcare staff and preschoolers with health problems that would interfere with participation in physical activities

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Growth and Nutrition Division

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Building Blocks for Healthy Preschoolers: Child Care and Family Models

Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.

Read the detailed description

The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:

  1. to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
  2. to examine the sustainability of the interventions
  3. to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).

Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.

Being tested
CHAMP, CHAMP+
Keywords
Overweight, Obesity, Prevention, Children, Childcare, Physical Activity, Nutrition, Wellness, Environment, Intervention, Feeding
Medical subject headings
Pediatric Obesity, Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHAMPBehavioural

    The CHAMP only group intervention is based on "Food Friends \& Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences. In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.

  • CHAMP+Behavioural

    The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment. The CHAMP+ intervention will span over the course of the CHAMP intervention.

Study groups in NCT03111264
Study groupRoleWhat they receive
CHAMP groupExperimentalChildcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods.
Receives: Behavioral: CHAMP
CHAMP+ groupExperimentalThese childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families.
Receives: Behavioral: CHAMP; Behavioral: CHAMP+
ControlNo interventionThis group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of BMI Z-score for preschoolers

    Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score

    Measured: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up

Secondary outcomes (5)

  1. Change of Physical Activity for preschoolers and childcare center staff

    Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics

    Measured: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up

  2. Change in Gross Motor Skills

    Measured by Test of Gross Motor Development-2

    Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

  3. Change in Preschoolers to try new foods

    Measured by Food Neophobia Scale (Caregiver report)

    Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

  4. Change in Preschoolers to try new foods

    Measured by Fruit \& Vegetable Knowledge \& Preference Test

    Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

  5. Change in Preschoolers to try new foods

    Measured by Food Tasting Assessment

    Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start17 Jun 2016
  3. Primary completion13 Mar 2020
  4. Study completion13 Mar 2020

Why it stopped: Covid-19 Closures \& Lockdown

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
The investigators will examine the impact of the teacher-led CHAMP intervention individually and combined with a CHAMP+ parenting intervention versus control on child BMI z-score, food tasting, food preferences and knowledge, gross motor skills, and physical activity.
Masking
Single blind
Who is masked
Participant
Enrolment
1,943 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111264
Sponsor's protocol ID
HP-00065933
Other IDs
1R01DK107761-01
Status last verified
May 2021
First submitted
27 Mar 2017
Last updated
10 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kowalski AJ, Armstrong B, Trude ACB, Arbaiza R, Czinn A, Bellows LL, Johnson SL, Wang Y, Hager ER, Black MM. Creating healthy habits for Maryland preschoolers (CHAMP): a cluster-randomized controlled trial among childcare centers. Int J Behav Nutr Phys Act. 2025 Dec 10;22(1):156. doi: 10.1186/s12966-025-01824-6.

    PubMed 41372951

  • Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2023 Apr;19(3):169-178. doi: 10.1089/chi.2022.0026. Epub 2022 Jun 1.

    PubMed 35649202

  • Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.

    PubMed 31525490

Questions about this trial

What is this clinical trial studying?

A study testing CHAMP and CHAMP+ in people with Pediatric Obesity, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Covid-19 Closures \& Lockdown). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of BMI Z-score for preschoolers (time frame: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03111264, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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