NCT00067600

Brief Summary

Osteoporosis affects nearly half of all American women over age 50. During the teenage years, girls can increase bone growth to decrease their risk of osteoporosis later in life. This study will test whether girls can change their food intake and physical activity patterns in ways that will increase their bone growth during the mid-teen years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2003

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

3.1 years

First QC Date

August 25, 2003

Last Update Submit

October 28, 2014

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Total Body Bone Mineral Density (TBBMD)

    Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years

    Baseline, 1 year, and 2 years

Secondary Outcomes (2)

  • Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide

    Baseline, 1 year, and 2 years

  • Plasma carotenoids and red cell folate

    Baseline, 1 year, and 2 years

Interventions

Diet with increased fruits, vegetables, and calciumBEHAVIORAL
Increased high impact activity and resistance trainingBEHAVIORAL

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • High school freshman or sophomore
  • Body mass index (BMI) from 16 through 23
  • Member of Kaiser Permanente Northwest Health Plan
  • Parent or guardian willing to participate

You may not qualify if:

  • Co-morbidity requiring a specific diet
  • Medication which contraindicates consuming a high-fiber diet
  • Life-threatening disease or other condition that would interfere with study participation
  • Current or past medically or self-diagnosed eating disorder
  • Current behaviors consistent with eating-related disorder
  • Pregnancy
  • Diagnosis of psychological disorder or difficulty within the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

  • DeBar LL, Ritenbaugh C, Aickin M, Orwoll E, Elliot D, Dickerson J, Vuckovic N, Stevens VJ, Moe E, Irving LM. Youth: a health plan-based lifestyle intervention increases bone mineral density in adolescent girls. Arch Pediatr Adolesc Med. 2006 Dec;160(12):1269-76. doi: 10.1001/archpedi.160.12.1269.

    PMID: 17146025DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

DietVegetablesCalciumResistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFoodFood and BeveragesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lynn L DeBar, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 26, 2003

Study Start

August 1, 2000

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

US(1)