Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

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ClinicalTrials.gov Identifier: NCT02202889

Recruitment Status : Completed

First Posted : July 29, 2014

Last Update Posted : July 29, 2014

Sponsor:

Collaborators:

University of Hawaii

Arizona State University

University of California, Davis

University of Nevada, Las Vegas

Ohio State University

Southern Illinois University

Information provided by (Responsible Party):

Dennis A. Savaiano, Purdue University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bone Development Dietary Adequacy	Behavioral: Adequate Calcium Today	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	848 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
Study Start Date :	September 2000
Actual Primary Completion Date :	September 2004
Actual Study Completion Date :	September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Drug Information available for: Calcium Gluconate

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Behavioral: Adequate 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).

Outcome Measures

Primary Outcome Measures :

Change in Bone Mineral Content [ Time Frame: 18 months ]
Baseline, 12 month and 18 month bone mineral content measured
Dietary Calcium [ Time Frame: 18 months ]
Dietary Calcium intake assessed by food frequency questionnaire

Secondary Outcome Measures :

Lactose maldigestion [ Time Frame: Baseline ]
Measured by breath hydrogen testing

Other Outcome Measures:

Perceived lactose intolerance [ Time Frame: Baseline ]
Measured by questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	10 Years to 13 Years (Child)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202889

Locations

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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907-2059

Sponsors and Collaborators

Purdue University

University of Hawaii

Arizona State University

University of California, Davis

University of Nevada, Las Vegas

Ohio State University

Southern Illinois University

Investigators

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Principal Investigator:	Dennis Savaiano, PhD	Purdue University
Principal Investigator:	Carol Boushey, PhD	University of Hawaii

More Information

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Responsible Party:	Dennis A. Savaiano, Professor and Associate Provost, Purdue University
ClinicalTrials.gov Identifier:	NCT02202889
Other Study ID Numbers:	00-52102-9696
First Posted:	July 29, 2014 Key Record Dates
Last Update Posted:	July 29, 2014
Last Verified:	July 2014

Keywords provided by Dennis A. Savaiano, Purdue University:


Adolescents Bone mass Calcium Perceived milk intolerance lactose maldigestion

Additional relevant MeSH terms:

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Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs

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