Childhood Obesity Prevention

Diabetes Clinical Trial

Official title:

Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630617
• Other study ID #: 04-06-14
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes
• Obesity
• Pediatric Obesity

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