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Center-based Preschooler Component. for Childhood Obesity

N/A
Waitlist Available
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline center environment at 17 weeks
Awards & highlights

Study Summary

This trial will study whether an intervention that includes a Facebook-based program and weekly letters sent to caregivers can help Head Start preschoolers establish healthy habits.

Eligible Conditions
  • Childhood Obesity
  • Risk Reduction Behavior
  • Early Intervention
  • Intergenerational Relations

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline diet quality at 17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline diet quality at 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Moderate-to-vigorous physical activity (MVPA; Preschoolers)-AIM 1
Secondary outcome measures
Diet quality (Preschoolers)-AIM 1
Proportion of overweight and obesity and body mass index z-score (Preschoolers)-AIM 1
Screen time (Preschoolers)-AIM 1
Other outcome measures
Diet quality (Caregivers)-AIM 2: Block Fruit-Vegetable-Fiber Screener
Feeding practice skill (Caregivers)-AIM 2
Head Start center environment
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment3 Interventions
The 16-week intervention includes three components: Caregiver Component. Facebook-based program including four new habit-formation tasks/week, and 3 face-to-face or virtual caregiver meetings: MSU research staff will lead the meetings at Head Start centers (weeks 1, 8, & 16) to connect caregivers to each other, offer health information, and discuss behavioral change strategies. Caregiver-Preschooler Learning. Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent privately to each caregiver , and caregivers will be asked to respond to the letters. Center-based Preschooler Component. Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators.
Group II: ControlActive Control1 Intervention
Control group will receive usual Head Start activities during intervention period. After post-intervention data collection, each control caregiver will receive all intervention supplies and a mini program including a face-to-face or virtual caregiver meeting and 1-week preschooler program. The caregiver meeting will cover contents on alternative cooking ingredients, food labels, and portion sizes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caregiver-Preschooler Learning.
2021
N/A
~100
Center-based Preschooler Component.
2021
N/A
~100
Caregiver Component.
2021
N/A
~100

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
183 Previous Clinical Trials
601,032 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant eligibility limited to individuals over 20 years old?

"According to the study parameters, prospective participants must be of preschool-age (3 - 5 years old). In contrast, 257 trials specifically target those under 18 while 608 studies focus on patients over 65."

Answered by AI

How many participants have joined the trial to date?

"Affirmative. The clinical trial is presently enrolling patients, with the first advertisement being posted on September 20th 2021 and edited as of June 29th 2022. A total of 144 participants will be accepted at a single site."

Answered by AI

What qualifications must potential participants meet to be involved in this trial?

"This medical study is looking to include 144 participants, who must have familial ties and be between 3-5 years old."

Answered by AI

Are there any open vacancies for participants in this clinical trial?

"Per the clinicaltrials.gov listing, this research is still open for enrolment. It was initially launched on September 20th 2021 and revised as recently as June 29th 2022."

Answered by AI
~27 spots leftby Mar 2025