Family Connections Weight Management

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00433901
First received: February 8, 2007
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Targeted parental instruction for positive lifestyle change with follow-up calls.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Managing Weight in Overweight and At-Risk Children

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Child BMI

Secondary Outcome Measures:
  • Parent BMI
  • Objective measure of physical activity using child accelorometer
  • Kids Eating Disorder Survey (KEDS)
  • Peds QOL survey
  • SE (self efficacy)
  • Self resport of physical activity
  • Self report of sedintary activity
  • Children's block food frequency survey
  • Parent's home environment survey
  • Parent self efficacy
  • Parent demographics
  • Parent QOL
  • Parent Rapid assessment of phycial activity (parent)
  • Parent Fat and Fiber survey
  • Parent Health Literacy
  • Child/family medical history
  • Economic survey type of medical weight management services

Estimated Enrollment: 220
Study Start Date: November 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433901

Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Paul A. Estabrooks, PhD Kaiser-Permanente of Colorado Clinical Research Unit
  More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Estabrooks, PhD, Kaiser Permanente Institute for Health Research
ClinicalTrials.gov Identifier: NCT00433901     History of Changes
Other Study ID Numbers: CO-04Esta-05
Study First Received: February 8, 2007
Last Updated: July 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
obesity in children
childhood disorders
overweight children
physical activity
home environment

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014