Childhood Obesity Prevention - Full Text View

Sponsors and Collaborators:	Western Michigan University Hillblom Foundation Commonwealth of the Northern Marianna Islands Public School System
Information provided by:	Western Michigan University
ClinicalTrials.gov Identifier:	NCT00630617

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

MedlinePlus related topics: Caregivers Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment
Official Title:	Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program

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:

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

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

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

Keywords provided by Western Michigan University:

Obesity
Prevention
Childhood
Children
Primary care-giver

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Diabetes Mellitus

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 15, 2009