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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00630617
Other study ID # 04-06-14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2004
Est. completion date July 2007

Study information

Verified date December 2023
Source Western Michigan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Currently having a third grader attending public school Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Northern Mariana Islands Commonwealth of the Northern Mariana Islands Public School System Saipan

Sponsors (3)

Lead Sponsor Collaborator
Western Michigan University Commonwealth of the Northern Marianna Islands Public School System, Hillblom Foundation

Country where clinical trial is conducted

Northern Mariana Islands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index 3 years
Secondary steps 3 years
Secondary Percent body fat 3 years
Secondary Basal metabolic rate 3 years
Secondary Diet information (child and primary care-giver) 3 years
Secondary Physical Activity and Inactivity information (child and primary care-giver) 3 years
Secondary Self esteem measures 3 years
Secondary Knowledge and attitudes 3 years
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