Early Childhood Prevention of Childhood Overweight

Development of an Early Intervention for the Prevention of Childhood Obesity

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Behavioral: 5-keys counseling; Behavioral: Lifestyle counseling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5-keys feeding program; Counseling in small groups aimed at enhancing children's self control over eating	Behavioral: 5-keys counseling; 5-session small group intervention; Behavioral: Lifestyle counseling; 5-session small group behavioral intervention
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; 5-session small group behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental control of feeding	Assessed by Questionnaire pre and post treatment.	5-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily patterns of child and family meals	Assessed by questionnaire pre and post treatment	1-week

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: William Stewart Agras, Stanford University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (Estimate): May 11, 2009

Study Record Updates

• Last Update Posted (Estimate): July 25, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: SU-04072009-2158