Impact of a Childhood Obesity Intervention for African American Families

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, Berkeley
Sponsor:
Information provided by (Responsible Party):
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT02044731
First received: January 22, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session childhood obesity intervention for African American families among children aged 5-12 years. We hypothesize that children participating in the program will experience a reduction in BMI.


Condition Intervention
Obesity
Overweight
Behavioral: Active and Healthy Families

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of a Childhood Obesity Intervention for African American Families

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: Baseline and at week 10 ] [ Designated as safety issue: No ]
    Change in BMI will be calculated from measured height and weight


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Baseline and at week 10 ] [ Designated as safety issue: No ]
    Change will be calculated based on measured blood pressure


Other Outcome Measures:
  • Parent weight [ Time Frame: Baseline and at week 10 ] [ Designated as safety issue: No ]
    Change will be calculated based on measured weight of parent

  • Parent reported behaviors [ Time Frame: Baseline and at 10 weeks ] [ Designated as safety issue: No ]
    Survey responses on parenting and child's dietary, physical activity, and screen time behaviors.

  • Parent blood pressure [ Time Frame: Baseline and at week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family group sessions
Active and Healthy Families
Behavioral: Active and Healthy Families
A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI greater than or equal to the 85th percentile for age and sex
  • Attends an elementary school in the Pittsburg Unified School District in California
  • Parent of child meeting above criteria

Exclusion Criteria:

-

  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: NCT02044731

Contacts
Contact: Jennifer Falbe, ScD, MPH 510-642-4861 jfalbe@berkeley.edu
Contact: Elena Barbot-wheaton, BA 510-642-5382 elena.barbot-wheaton@berkeley.edu

Locations
United States, California
Parkside Elementary School Recruiting
Pittsburg, California, United States, 94565
Contact: Michelle Rivero, MPH    925-313-6158    michelle.rivero@hsd.cccounty.us   
Principal Investigator: Kristine A Madsen, MD         
Sponsors and Collaborators
University of California, Berkeley
Investigators
Principal Investigator: Kristine A Madsen, MD University of California, Berkeley
  More Information

No publications provided

Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02044731     History of Changes
Other Study ID Numbers: 2012-07-4508 B, 033728B
Study First Received: January 22, 2014
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Berkeley:
Schools
Pediatrics
Obesity
Overweight
Intervention Studies
African Americans
Family
Body mass index

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

ClinicalTrials.gov processed this record on September 16, 2014