Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

Bone Development Clinical Trial

Official title:

Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202889
• Other study ID #: 00-52102-9696
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: July 25, 2014
• Start date: September 2000
• Est. completion date: September 2004

Study information

• Verified date: July 2014
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• 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).

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (7)

Lead Sponsor	Collaborator
Purdue University	Arizona State University, Ohio State University, Southern Illinois University, University of California, Davis, University of Hawaii, University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived lactose intolerance	Measured by questionnaire	Baseline	No
Primary	Change in Bone Mineral Content	Baseline, 12 month and 18 month bone mineral content measured	18 months	No
Primary	Dietary Calcium	Dietary Calcium intake assessed by food frequency questionnaire	18 months	No
Secondary	Lactose maldigestion	Measured by breath hydrogen testing	Baseline	No