Back to results

Childhood Obesity Prevention

Primary Purpose

Childhood Obesity, Diabetes

Status

Completed

Phase

Not Applicable

Locations

Northern Mariana Islands

Study Type

Interventional

Intervention

Diet, Physical activity, Physical inactivity

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Prevention, Childhood, Children, Primary care-giver

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Currently having a third grader attending public school

Exclusion Criteria:

None

Sites / Locations

Commonwealth of the Northern Mariana Islands Public School System

Outcomes

Primary Outcome Measures

Body Mass Index

Secondary Outcome Measures

steps

Percent body fat

Basal metabolic rate

Diet information (child and primary care-giver)

Physical Activity and Inactivity information (child and primary care-giver)

Self esteem measures

Knowledge and attitudes

Full Information

NCT ID

NCT00630617

First Posted

February 28, 2008

Last Updated

February 28, 2008

Sponsor

Western Michigan University

Collaborators

Hillblom Foundation, Commonwealth of the Northern Marianna Islands Public School System

1. Study Identification

Unique Protocol Identification Number

NCT00630617

Brief Title

Childhood Obesity Prevention

Official Title

Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Western Michigan University

Collaborators

Hillblom Foundation, Commonwealth of the Northern Marianna Islands Public School System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity, Diabetes

Keywords

Obesity, Prevention, Childhood, Children, Primary care-giver

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

900 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Diet, Physical activity, Physical inactivity

Intervention Description

Community based participatory research design

Primary Outcome Measure Information:

Title

Body Mass Index

Time Frame

3 years

Secondary Outcome Measure Information:

Title

steps

Time Frame

3 years

Title

Percent body fat

Time Frame

3 years

Title

Basal metabolic rate

Time Frame

3 years

Title

Diet information (child and primary care-giver)

Time Frame

3 years

Title

Physical Activity and Inactivity information (child and primary care-giver)

Time Frame

3 years

Title

Self esteem measures

Time Frame

3 years

Title

Knowledge and attitudes

Time Frame

3 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Currently having a third grader attending public school Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mozhdeh B Bruss, PhD

Organizational Affiliation

Western Michigan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Commonwealth of the Northern Mariana Islands Public School System

City

Saipan

ZIP/Postal Code

96950

Country

Northern Mariana Islands

12. IPD Sharing Statement

Learn more about this trial

Childhood Obesity Prevention

We'll reach out to this number within 24 hrs