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Early Childhood Prevention of Childhood Overweight

Primary Purpose

Overweight

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

5-keys counseling

Lifestyle counseling

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

2 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5-keys feeding program

Healthy lifestyle counseling

Arm Description

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

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

Outcomes

Primary Outcome Measures

Parental control of feeding

Assessed by Questionnaire pre and post treatment.

Secondary Outcome Measures

Daily patterns of child and family meals

Assessed by questionnaire pre and post treatment

Full Information

NCT ID

NCT00896545

First Posted

May 7, 2009

Last Updated

July 21, 2011

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00896545

Brief Title

Early Childhood Prevention of Childhood Overweight

Official Title

Development of an Early Intervention for the Prevention of Childhood Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5-keys feeding program

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy lifestyle counseling

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

5-keys counseling

Intervention Description

5-session small group intervention

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle counseling

Intervention Description

5-session small group behavioral intervention

Primary Outcome Measure Information:

Title

Parental control of feeding

Description

Assessed by Questionnaire pre and post treatment.

Time Frame

5-weeks

Secondary Outcome Measure Information:

Title

Daily patterns of child and family meals

Description

Assessed by questionnaire pre and post treatment

Time Frame

1-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

4 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Stewart Agras

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

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Early Childhood Prevention of Childhood Overweight

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