NCT00245180

Brief Summary

The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
577

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable cardiovascular-diseases

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

First Submitted

Initial submission to the registry

October 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 12, 2014

Status Verified

April 1, 2006

Enrollment Period

6.3 years

First QC Date

October 26, 2005

Last Update Submit

March 10, 2014

Conditions

Cardiovascular DiseasesHeart DiseasesObesity

Outcome Measures

Primary Outcomes (1)

  • BMI

    birth, 6,12,18, and 24 months

Secondary Outcomes (1)

  • feeding

    0-24 months

Study Arms (1)

control

NO INTERVENTION

Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.

Behavioral: DietBehavioral: Exercise

Interventions

DietBEHAVIORAL
control
ExerciseBEHAVIORAL
control

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who have had uncomplicated pregnancies
  • Women who agree to have their child enrolled in the study and followed for 30 months
  • Women who are not planning to leave their area within 2 years of study start

You may not qualify if:

  • Women whose children have a serious illness known to affect normal growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesObesity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Njeri Karanja

    Kaiser Foundation Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 27, 2005

Study Start

May 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 12, 2014

Record last verified: 2006-04