NCT02202889

Brief Summary

School based educational intervention to educate on bone health among Hispanic, Asian or non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium intake and bone density in . The hypothesis was that the educational program would increase knowledge, improve dairy food and calcium consumption and enhance bone health in this population. A secondary hypothesis was that lactose maldigestion would be an impediment to improved dairy food consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
848

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 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

September 1, 2000

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

4 years

First QC Date

July 24, 2014

Last Update Submit

July 25, 2014

Conditions

Bone DevelopmentDietary Adequacy

Keywords

AdolescentsBone massCalciumPerceived milk intolerancelactose maldigestion

Outcome Measures

Primary Outcomes (2)

  • Change in Bone Mineral Content

    Baseline, 12 month and 18 month bone mineral content measured

    18 months

  • Dietary Calcium

    Dietary Calcium intake assessed by food frequency questionnaire

    18 months

Secondary Outcomes (1)

  • Lactose maldigestion

    Baseline

Other Outcomes (1)

  • Perceived lactose intolerance

    Baseline

Interventions

Adequate Calcium TodayBEHAVIORAL

A school-randomized behavioral intervention study called the Adequate Calcium Today (ACT) project was conducted in sixth grade classrooms located in six states (Arizona, California, Hawaii, Indiana, Nevada, and Ohio).

Eligibility Criteria

Age10 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Middle schools within one-hour driving time of one of the designated DXA measurement sites were eligible to participate in ACT if their student population had a higher proportion of Asian or Hispanic students than the respective state's average. - Girls recruited for evaluation measures were limited to those being at least 75% Asian, Hispanic or non-Hispanic White based on the race/ethnicity of their biological parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907-2059, United States

Location

Study Officials

  • Dennis Savaiano, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Carol Boushey, PhD

    University of Hawaii

    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
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Provost

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 29, 2014

Study Start

September 1, 2000

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)