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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12-months, 18-months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body fat percent

Secondary study objectives

Body Mass Index (BMI) percentile

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out