OsteoporosisPhase 1NCT00067600
Improving Bone Health in Adolescent Girls: The Youth Osteoporosis and Understanding Total Health (YOUTH) Study
A Phase 1 study testing Diet with increased fruits, vegetables, and calcium and Increased high impact activity and resistance training in people with Osteoporosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Diet with increased fruits, vegetables, and calcium and Increased high impact activity and resistance training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Sep 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Lifestyle Changes to Increase Bone Density in Teen Girls
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Diet with increased fruits, vegetables, and calcium, Increased high impact activity and resistance training
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with increased fruits, vegetables, and calciumBehavioural
Increased high impact activity and resistance trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Bone Mineral Density (TBBMD)
Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
Measured: Baseline, 1 year, and 2 years
Secondary outcomes (2)
Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide
Biologic measures of bone metabolism
Measured: Baseline, 1 year, and 2 years
Plasma carotenoids and red cell folate
Biologic measures of dietary change
Measured: Baseline, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2003 (estimated)
- Study startAug 2000
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 228 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lynn L DeBar, PhD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067600
- Sponsor's protocol ID
- R01HD037744
- Status last verified
- Oct 2014
- First submitted
- 25 Aug 2003
- Last updated
- 29 Oct 2014
- Results posted
- No
Publications
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.
PubMed 17146025
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes to Increase Bone Density in Teen Girls
- ClinicalTrials.gov ID
- NCT00067600
- Acronym / sponsor ID
- R01HD037744
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 26 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet with increased fruits, vegetables, and calcium | Behavioural | – |
| Increased high impact activity and resistance training | Behavioural | – |
Primary outcome
Total Body Bone Mineral Density (TBBMD)
Time frame: Baseline, 1 year, and 2 years
Changes in TBBMD as measured by DEXA at baseline, 1 year, and 2 years
2 secondary outcomes
Serum osteocalcin, alkaline phosphatase, and urinary n-telopeptide
Time frame: Baseline, 1 year, and 2 years
Plasma carotenoids and red cell folate
Time frame: Baseline, 1 year, and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Derived from this study: PubMed 17146025DeBar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn L DeBar, PhD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diet with increased fruits, vegetables, and calcium and Increased high impact activity and resistance training in people with Osteoporosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Bone Mineral Density (TBBMD) (time frame: Baseline, 1 year, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.