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CompletedNCT02202889Updated Jul 29, 2014

Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

An interventional study of Adequate Calcium Today in Bone Development and Dietary Adequacy, sponsored by Purdue University. Completed at 1 site in United States. Open to female participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by Purdue University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
848
Allocation
Not applicable
Ages
10 Years to 13 Years
Sex
Female
01

Study 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.

Read the detailed description

A targeted behavioral intervention to improve calcium intake and bone mass was conducted at middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a multiple linear regression to examine the impact of the intervention while accounting for PMI and LM and adjusting for covariates.

02

Conditions studied

  • Bone Development
  • Dietary Adequacy

Keywords

  • Adolescents
  • Bone mass
  • Calcium
  • Perceived milk intolerance
  • lactose maldigestion
03

In context

Lead sponsor

Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
848 participants (actual)

Interventions

  • BehavioralAdequate Calcium Today

    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).

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What researchers measure

Primary outcomes

  1. Change in Bone Mineral Content

    Baseline, 12 month and 18 month bone mineral content measured

    Time frame: 18 months

  2. Dietary Calcium

    Dietary Calcium intake assessed by food frequency questionnaire

    Time frame: 18 months

Secondary outcomes

  1. Lactose maldigestion

    Measured by breath hydrogen testing

    Time frame: Baseline

Other outcomes

  1. Perceived lactose intolerance

    Measured by questionnaire

    Time frame: Baseline

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47907-2059, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02202889
Lead sponsor
Purdue University
Collaborators
University of Hawaii, Arizona State University, University of California, Davis, University of Nevada, Las Vegas, Ohio State University, Southern Illinois University
Responsible party
Dennis A. Savaiano (Professor and Associate Provost, Purdue University) — Principal investigator
First posted
Jul 29, 2014
Start date
Sep 2000
Primary completion
Sep 2004
Completion
Sep 2004
Last update
Jul 29, 2014

Study contacts

Dennis Savaiano, PhD
principal investigator · Purdue University
Carol Boushey, PhD
principal investigator · University of Hawaii

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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