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Completed

NCT Number: NCT02202889

Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

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.

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Key information

Conditions

Bone Development Dietary Adequacy

Age range

10 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907-2059, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Adequate Calcium Today

Behavioral

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).

Primary outcomes

  1. Change in Bone Mineral Content

    Time frame: 18 months

    Baseline, 12 month and 18 month bone mineral content measured

  2. Dietary Calcium

    Time frame: 18 months

    Dietary Calcium intake assessed by food frequency questionnaire

Secondary outcomes

  1. Lactose maldigestion

    Time frame: Baseline

    Measured by breath hydrogen testing

Other outcomes

  1. Perceived lactose intolerance

    Time frame: Baseline

    Measured by questionnaire

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Arizona State University
  • Ohio State University
  • Southern Illinois University
  • University of California, Davis
  • University of Hawaii
  • University of Nevada, Las Vegas

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Jul 29, 2014
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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