NCT00630617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

February 28, 2008

Last Update Submit

December 5, 2023

Conditions

Childhood ObesityDiabetes

Keywords

ObesityPreventionChildhoodChildrenPrimary care-giver

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    3 years

Secondary Outcomes (7)

  • steps

    3 years

  • Percent body fat

    3 years

  • Basal metabolic rate

    3 years

  • Diet information (child and primary care-giver)

    3 years

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

    3 years

  • +2 more secondary outcomes

Interventions

Diet, Physical activity, Physical inactivityBEHAVIORAL

Community based participatory research design

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Currently having a third grader attending public school

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Commonwealth of the Northern Mariana Islands Public School System

Saipan, 96950, Northern Mariana Islands

Location

MeSH Terms

Conditions

Pediatric ObesityDiabetes MellitusObesity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mozhdeh B Bruss, PhD

    Western Michigan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

NO(1)