NCT00896545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

2.5 years

First QC Date

May 7, 2009

Last Update Submit

July 21, 2011

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • Parental control of feeding

    Assessed by Questionnaire pre and post treatment.

    5-weeks

Secondary Outcomes (1)

  • Daily patterns of child and family meals

    1-week

Study Arms (2)

5-keys feeding program

EXPERIMENTAL

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

Behavioral: 5-keys counselingBehavioral: Lifestyle counseling

Healthy lifestyle counseling

ACTIVE COMPARATOR

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

Behavioral: Lifestyle counseling

Interventions

5-keys counselingBEHAVIORAL

5-session small group intervention

5-keys feeding program
Lifestyle counselingBEHAVIORAL

5-session small group behavioral intervention

5-keys feeding programHealthy lifestyle counseling

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • \- Inadequate understanding of the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • William Stewart Agras

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 11, 2009

Study Start

November 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(1)