Childhood Obesity Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630617
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 7, 2008
Hillblom Foundation
Commonwealth of the Northern Marianna Islands Public School System
Information provided by:
Western Michigan University

Brief Summary:

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 or disease Intervention/treatment Phase
Childhood Obesity Diabetes Behavioral: Diet, Physical activity, Physical inactivity Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program
Study Start Date : July 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Intervention Details:
  • Behavioral: Diet, Physical activity, Physical inactivity
    Community based participatory research design

Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. steps [ Time Frame: 3 years ]
  2. Percent body fat [ Time Frame: 3 years ]
  3. Basal metabolic rate [ Time Frame: 3 years ]
  4. Diet information (child and primary care-giver) [ Time Frame: 3 years ]
  5. Physical Activity and Inactivity information (child and primary care-giver) [ Time Frame: 3 years ]
  6. Self esteem measures [ Time Frame: 3 years ]
  7. Knowledge and attitudes [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Currently having a third grader attending public school

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630617

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
Principal Investigator: Mozhdeh B Bruss, PhD Western Michigan University

Responsible Party: Mozhdeh B. Bruss, PhD, MPH, RD/Associate Professor, Western Michigan University Identifier: NCT00630617     History of Changes
Other Study ID Numbers: 04-06-14
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: February 2008

Keywords provided by Western Michigan University:
Primary care-giver

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