Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

Not Applicable

Completed

• Conditions: Dietary Adequacy; Bone Development

• Registration Number: NCT02202889
• Lead Sponsor: Purdue University

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 Timeline

• Study Start: 2000-09
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-25
• Last Update Submitted: 2014-07-25
• Study First Posted: 2014-07-29
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 848

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lactose maldigestion	Baseline	Measured by breath hydrogen testing

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States