NCT00063050

Brief Summary

The purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2000

Typical duration for phase_2

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

April 1, 2000

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

June 19, 2003

Last Update Submit

November 14, 2011

Conditions

Osteoporosis

Keywords

Bone densityChildrenAdolescentsBehaviorHealth educationHealth promotionPhysical fitnessDietParent trainingInjury control

Outcome Measures

Primary Outcomes (4)

  • DXA - at baseline and 9 months

  • Nutrient Intake Interview - at baseline, 3, 9 and 12 months

  • Physical Activity Recall - at baseline, 3, 9 and 12 months

  • Strength/Fitness measures - at baseline, 3, 9 and 12 months

Interventions

Physical activity and nutrition interventionBEHAVIORAL

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participates in organized sports less than 3 days a week and less than 9 months per year
  • Parent willing to attend weekly training sessions

You may not qualify if:

  • Serious medical illness
  • Spends less than 4 days a week with the parent willing to attend classes
  • Body mass index \> 32

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University

San Diego, California, 92123, United States

Location

Related Publications (3)

  • Schmitz KE, Hovell MF, Nichols JF, Irvin VL, Keating K, Simon GM, Gehrman C, Jones KL. Validation study of adolescents' puberty self-assessments. Journal of Early Adolescence 2004; 24(4): 357-384.

    BACKGROUND

  • Nichols JF, Irvin V, Schmitz KE, Hovell MF. Body Composition and Fat Distribution in Non-Hispanic White and Hispanic Pre-Adolescents. Int J of Body Comp Res 6(1):9-16, 2008.

    BACKGROUND

  • Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10.4278/ajhp.08021111.

    PMID: 19928484RESULT

MeSH Terms

Conditions

OsteoporosisBehaviorHealth Education

Interventions

ExerciseDiet Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Officials

  • Melbourne F. Hovell, Ph.D., MPH

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of CBEACH, Distinguished Professor of Public Health

Study Record Dates

First Submitted

June 19, 2003

First Posted

June 20, 2003

Study Start

April 1, 2000

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

US(1)