NCT00788203

Completed

Prevention of Childhood Obesity

Stanford University Source

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Other study identifiers

Sponsor study identifier

SU-11052008-1335

Secondary identifiers

R21HD055637

NIH

Study Type

observational

Actual enrollment (reported)

130

Locations

1 country

Sites

1

Timeline

Study Start

August 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2011

Actual (reported)

Study Completion

May 2011

Actual (reported)

Brief Summary

This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 130 participants
Study completion date: May 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 6, 2008
Actual (reported)
First Posted
November 10, 2008
Actual (reported)
Primary Completion
May 2011
Actual (reported)
Study Completion
May 2011
Actual (reported)

Last Updated: July 25, 2011
Status Verified: July 2011
Last Update Submitted: July 21, 2011

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

Parental restraint concerning eating
Prospective

Secondary Outcomes (1)

Daily eating pattern
Weekly

Study Arms (2)

5-keys program

Counseling re family feeding behaviors.

Lifestyle counseling

Counseling re healthy eating for child and family

Eligibility Criteria

Age2 Years - 4 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Children aged 2-4 years at risk for overweight with at least one overweight/obese parent

You may qualify if:

For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be entered to the study. Children of these families will be at risk for overweight because the family will contain at least one obese parent. For study 2, 100 families (200 parents) will be entered to the study. Children of these families will be at risk for overweight and have a reactive temperament. The reason for using this population is that a combination of parental obesity and a child with a reactive temperament appears to put the child at high risk for the development of overweight.\

Sponsors & Collaborators

Stanford University
Otherlead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

William Stewart Agras
Stanford University
PRINCIPAL INVESTIGATOR

Enrollment

130 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 10, 2008

Study Start

August 2008

Date type not reported

This date has not been verified as actual or estimated.

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You may not qualify if:

Not able to comprehend English well enough to participate in assessments or the intervention.
Serious non-obesity related physical illness, (e.g., cancer), which would preclude participation in assessment or intervention.
Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar disorder, mental retardation that would preclude participation in assessment or intervention.
Single parents
Serious physical illness or related treatments that would affect feeding or weight including history of feeding aversion, failure to thrive, and use of nasogastric or gastrostomy feeding.
Prematurity below 37-weeks associated with prolonged hospitalization, ongoing need for nutritional supplementation, or naso-gastric feeding.(parental report)
Serious current developmental problems including any that might interfere with self-feeding or require additional parental feeding support e.g. developmental delay, autism. (parental report).

Contact the study team to confirm eligibility.

Primary Completion

May 2011

Actual (reported)

Study Completion

May 2011

Actual (reported)

Last Updated

July 25, 2011

Record last verified: 2011-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00788203
Data provider: ClinicalTrials.gov
Source updated: 2011-07-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:26 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

5-keys program

Lifestyle counseling

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations