Clinical trial NCT00067600: Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
Official title: Lifestyle Changes to Increase Bone Density in Teen Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-08-26
Enrollment: 228
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Detailed description: Osteoporosis-related fractures incur an annual cost in the United States of more than $8 billion. Peak bone mass is achieved in the late teens and early 20s. An important component of a lifelong osteoporosis prevention strategy is to maximize bone mineral content during the teen years and establish lifestyle patterns that will help maintain bone mineral content through menopause. This trial will test the efficacy of a comprehensive lifestyle intervention to build bone and prevent bone loss among adolescent women 14 to 16 years of age.

Participants in this study will be randomized to either an intervention group or an attention control group. The intervention program includes a physical activity component involving high impact and spinal motion activities and a diet component rich in fruits, vegetables, and calcium. Participants will take part in group and individual meetings and activities and receive coaching telephone calls. Participants will be assessed at study entry and two annual follow-up visits. Primary outcome measures include objective measures (serum folate and carotenoids urinary sodium, lean body mass, accelerometer measure of physical activity) and self-reports.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Total Body Bone Mineral Density (TBBMD)
timeFrame: Baseline, 1 year, and 2 years
Secondary outcomes:
measure: Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide
timeFrame: Baseline, 1 year, and 2 years
measure: Plasma carotenoids and red cell folate
timeFrame: Baseline, 1 year, and 2 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Lynn L DeBar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.