Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

• ClinicalTrials.gov Identifier: NCT02202889
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Last Update Posted: July 29, 2014
• 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
• Information provided by (Responsible Party): Dennis A. Savaiano, Purdue University

Tracking Information

• First Submitted Date: July 24, 2014
• First Posted Date: July 29, 2014
• Last Update Posted Date: July 29, 2014
• Study Start Date: September 2000
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 25, 2014)

Lactose maldigestion [ Time Frame: Baseline ]

Measured by breath hydrogen testing

• Original Secondary Outcome Measures: 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: Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Bone Development
• Dietary Adequacy

Intervention

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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 25, 2014): 848
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2004
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Eligibility 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:

-

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 10 Years to 13 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02202889
• Other Study ID Numbers: 00-52102-9696
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dennis A. Savaiano, Purdue University
• Study 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

Investigators

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

• PRS Account: Purdue University
• Verification Date: July 2014