NCT00433901

Brief Summary

The prevalence of overweight children has increased significantly over the past 3 decades and 3 out of every 4 overweight children become obese adults. Additionally, overweight children are now at risk for developing type-2 diabetes while still in their youth. To address the issue of childhood weight management, Golan and colleagues provided a model for intervention development that targets parents as an exclusive agent of change when attempting to treat weight issues for children under 12 years of age. The Kaiser Permanente Colorado (KPCO) Weight Management Program (WMP) developed Family Connections, a condensed two-session program, based on the Golan model, for parents of children between the ages of 8-12 with a Body Mass Index (BMI) greater than the 85 percentile for age and gender. There is a need to determine if the content of Golan's model can be translated into a practical intervention to be used in usual pediatric weight management practice. The Family Connections study uses three arms to determine the effectiveness of healthy eating and active living messages.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

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, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

4.3 years

First QC Date

February 8, 2007

Last Update Submit

July 16, 2010

Conditions

Keywords

obesity in childrenchildhood disordersoverweight childrenphysical activityhome environment

Outcome Measures

Primary Outcomes (1)

  • Child BMI

Secondary Outcomes (17)

  • Parent BMI

  • Objective measure of physical activity using child accelorometer

  • Kids Eating Disorder Survey (KEDS)

  • Peds QOL survey

  • SE (self efficacy)

  • +12 more secondary outcomes

Interventions

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All boys and girls within the KPCO HMO system of the greater Denver area who are between the ages of 8 and 12 at the time of the initial assessment with a BMI of 85% or above.

You may not qualify if:

  • Parents for whom English is not their language of communication
  • Families who intend to move within the first three months of intervention
  • Families who do not have access to a telephone
  • Did not agree to be randomized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Estabrooks PA, Shoup JA, Gattshall M, Dandamudi P, Shetterly S, Xu S. Automated telephone counseling for parents of overweight children: a randomized controlled trial. Am J Prev Med. 2009 Jan;36(1):35-42. doi: 10.1016/j.amepre.2008.09.024.

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Paul A. Estabrooks, PhD

    Kaiser-Permanente of Colorado Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

November 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 20, 2010

Record last verified: 2010-07