Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 24, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date July 29, 2014
Study Start Date  ICMJE September 2000
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
Lactose maldigestion [ Time Frame: Baseline ]
Measured by breath hydrogen testing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2014)
Perceived lactose intolerance [ Time Frame: Baseline ]
Measured by questionnaire
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
Official Title  ICMJE Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Bone Development
  • Dietary Adequacy
Intervention  ICMJE 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).
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
848
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02202889
Other Study ID Numbers  ICMJE 00-52102-9696
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dennis A. Savaiano, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE
  • University of Hawaii
  • Arizona State University
  • University of California, Davis
  • University of Nevada, Las Vegas
  • Ohio State University
  • Southern Illinois University
Investigators  ICMJE
Principal Investigator: Dennis Savaiano, PhD Purdue University
Principal Investigator: Carol Boushey, PhD University of Hawaii
PRS Account Purdue University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP