Early Childhood Prevention of Childhood Overweight

Overweight Clinical Trial

Official title:

Development of an Early Intervention for the Prevention of Childhood Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896545
• Other study ID #: SU-04072009-2158
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2009
• Last updated: July 21, 2011
• Start date: November 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• One or both parents with BMI > or = to 27.5

• Healthy child ages 2-4 years

Exclusion criteria.

• Inadequate understanding of the English language

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• 5-keys counseling
5-session small group intervention
• Lifestyle counseling
5-session small group behavioral intervention

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental control of feeding	Assessed by Questionnaire pre and post treatment.	5-weeks	No
Secondary	Daily patterns of child and family meals	Assessed by questionnaire pre and post treatment	1-week	No