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CompletedNCT00896545Updated Jul 25, 2011

Early Childhood Prevention of Childhood Overweight

A Phase 3 interventional study of 5-keys counseling and Lifestyle counseling in Overweight, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 2 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-25.

Sponsored by Stanford University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 4 Years
Sex
All
01

Study summary

You are invited to participate in a research study to understand more about childhood obesity and how to prevent it. We hope to learn how families influence each others eating habits.

Read the detailed description

This study aims to understand more about childhood obesity and how to prevent it. Two different methods of prevention will be tested and participants will be allocated at random to one of these methods. The investigators hope to learn how families influence each others eating habits.

Participants in this study will attend a series of five classes, once a week for five weeks, on the topic of child feeding. The aim of the classes is to learn how to feed your child so as to prevent future eating and weight problems. The research component includes filling out some surveys before classes begin and at the end of the last class. Classes are small and interactive so that parents have a chance to voice concerns and get feedback.

02

Conditions studied

  • Overweight

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03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • One or both parents with BMI > or = to 27.5
  • Healthy child ages 2-4 years

Exclusion criteria

Exclusion criteria.

- Inadequate understanding of the English language

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    5-keys feeding program

    Counseling in small groups aimed at enhancing children's self control over eating

    Behavioral: 5-keys counseling · Behavioral: Lifestyle counseling

  • Active comparator
    Healthy lifestyle counseling

    Counseling in small groups aimed at achieving healthy eating patterns aimed at both the family and young children

    Behavioral: Lifestyle counseling

Interventions

  • Behavioral5-keys counseling

    5-session small group intervention

  • BehavioralLifestyle counseling

    5-session small group behavioral intervention

06

What researchers measure

Primary outcomes

  1. Parental control of feeding

    Assessed by Questionnaire pre and post treatment.

    Time frame: 5-weeks

Secondary outcomes

  1. Daily patterns of child and family meals

    Assessed by questionnaire pre and post treatment

    Time frame: 1-week

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00896545
First posted
May 11, 2009
Start date
Nov 2008
Primary completion
May 2011
Completion
May 2011
Last update
Jul 25, 2011

Study contacts

William Stewart Agras
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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