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Diet and Lifestyle Intervention for Childhood Obesity

N/A
Waitlist Available
Led By Linda V Van Horn, PhD
Research Sponsored by Northwestern 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 baseline, 12-months, 18-months
Awards & highlights

Study Summary

This trial will test whether a diet and lifestyle intervention can improve cardiovascular health metrics in children.

Who is the study for?
The KIDFIT trial is for preschool-age children (3-5 years old) with overweight or obese mothers who have a BMI of 25-40 kg/m2. The mother-child pairs must be willing to participate in the study activities, including diet and lifestyle changes, and attend study visits. They cannot join if they plan to move soon or if the child has a condition that prevents following the diet and activity guidelines.Check my eligibility
What is being tested?
KIDFIT is testing two interventions: KIDFIT HEALTHY and KIDFIT SAFE, focusing on improving children's body fat percentage, BMI percentiles, diet quality based on DASH scores, physical activity levels, blood pressure, blood lipids without affecting their height negatively over a 12-month period.See study design
What are the potential side effects?
There are no specific side effects mentioned for this intervention as it involves general lifestyle improvements such as better dieting practices and increased physical activity. However, all health interventions should be monitored for individual responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12-months, 18-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12-months, 18-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body fat percent
Secondary outcome measures
Body Mass Index (BMI) percentile

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KIDFIT HEALTHYExperimental Treatment1 Intervention
The KIDFIT intervention group combines traditional in-person and electronic participant contacts, including two scheduled individual visits with a nutrition coach, coaching calls throughout the year, and monthly group videoconferencing-type sessions. KIDFIT Healthy participants will attend both baseline and 12 month clinical visits.
Group II: KIDFIT SAFEActive Control1 Intervention
The Control Group will be provided 12 web-based monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms. KIDFIT Safe web site targets environmentally safe childcare related topics such as use of sun screen, avoidance of choking hazards, pet safety, protection from electrical appliances, etc. KIDFIT Safe participants will attend both baseline and 12 month clinical visits.

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Who is running the clinical trial?

American Heart AssociationOTHER
333 Previous Clinical Trials
4,934,106 Total Patients Enrolled
25 Trials studying Obesity
2,949 Patients Enrolled for Obesity
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,607 Total Patients Enrolled
33 Trials studying Obesity
11,332 Patients Enrolled for Obesity
Linda V Van Horn, PhDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
281 Total Patients Enrolled

Media Library

KIDFIT HEALTHY Clinical Trial Eligibility Overview. Trial Name: NCT03405246 — N/A
Obesity Research Study Groups: KIDFIT SAFE, KIDFIT HEALTHY
Obesity Clinical Trial 2023: KIDFIT HEALTHY Highlights & Side Effects. Trial Name: NCT03405246 — N/A
KIDFIT HEALTHY 2023 Treatment Timeline for Medical Study. Trial Name: NCT03405246 — N/A
~8 spots leftby Jun 2025
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