Childhood Obesity Prevention

This study has been completed.
Sponsor:
Collaborators:
Hillblom Foundation
Commonwealth of the Northern Marianna Islands Public School System
Information provided by:
Western Michigan University
ClinicalTrials.gov Identifier:
NCT00630617
First received: February 28, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

To develop and evaluate a culturally appropriate childhood obesity prevention program targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle intervention consisted of eight, 90-minute sessions at the elementary schools.

Primary outcome: body mass index of third graders and their primary care-givers Primary objective: To engage primary care-givers of third grand children in identifying and creating health promoting culturally appropriate environments for young children.


Condition Intervention
Childhood Obesity
Diabetes
Behavioral: Diet, Physical activity, Physical inactivity

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program

Resource links provided by NLM:


Further study details as provided by Western Michigan University:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • steps [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Percent body fat [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Basal metabolic rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Diet information (child and primary care-giver) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Physical Activity and Inactivity information (child and primary care-giver) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Self esteem measures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Knowledge and attitudes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: July 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Diet, Physical activity, Physical inactivity
    Community based participatory research design
Detailed Description:

The sessions include information about energy balance, portion control, appropriate amounts and types of physical activity, physical inactivity, nutrition and self-esteem. The influence of the primary care-giver on the children's physical activity and nutritional behaviors may lead to greater or lesser rates of obesity in childhood and eventually lead to adult obesity. Therefore, the intention of this intervention is to educate primary care-givers so as to effect change (in a positive way) in the children they care for. Assessment on steps taken, BMI, percent body fat, diet, self reported physical activity and diet will be used to evaluate the impact of the sessions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently having a third grader attending public school

Exclusion Criteria:

  • None
  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: NCT00630617

Locations
Northern Mariana Islands
Commonwealth of the Northern Mariana Islands Public School System
Saipan, Northern Mariana Islands, 96950
Sponsors and Collaborators
Western Michigan University
Hillblom Foundation
Commonwealth of the Northern Marianna Islands Public School System
Investigators
Principal Investigator: Mozhdeh B Bruss, PhD Western Michigan University
  More Information

No publications provided

Responsible Party: Mozhdeh B. Bruss, PhD, MPH, RD/Associate Professor, Western Michigan University
ClinicalTrials.gov Identifier: NCT00630617     History of Changes
Other Study ID Numbers: 04-06-14
Study First Received: February 28, 2008
Last Updated: February 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Western Michigan University:
Obesity
Prevention
Childhood
Children
Primary care-giver

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

ClinicalTrials.gov processed this record on September 18, 2014