Cardiovascular DiseasesPhase 2TAAGNCT00006409
Trial of Activity for Adolescent Girls (TAAG)
A Phase 2 study testing Trial of Activity for Adolescent Girls (TAAG) in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill.
Trial summary
To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8. Read more about this study
- Who is it for?
- Ages 12 to 14 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- Trial of Activity for Adolescent Girls (TAAG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,727 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 14 years
- Women only
- No healthy volunteers
- Child
School inclusion criteria:
- Public middle schools in which a majority of students lived in the surrounding community
- Enrollment of at least 90 8th-grade girls
- Yearly withdrawal rates less than 28%
- At least one semester of physical education required for each grade
- Willingness to sign a memorandum of understanding and accept random assignment of the school
Student exclusion criteria:
- Limited English-speaking skills
- Unable to participate in physical education classes due to a medical condition or disability
- Contraindications for participating in a submaximal exercise test
About this study
To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
Read the detailed description
BACKGROUND:
The Report of the Surgeon General on Physical Activity and Health (USDHHS, 1996) emphasized that regular physical activity has important health benefits including reducing the risk of heart disease, and helping to treat and prevent high blood pressure, high cholesterol, and diabetes, and to prevent osteoporosis and colon cancer. In addition, physical activity helps control weight, reduces feelings of depression and anxiety, and promotes psychological well being. Inactivity increases with age and is more common among women than men and among those with lower income, less education, and in minorities (USDHHS, 1996). Even though adolescents are more active than adults, many do not engage in recommended levels of physical activity, and participation declines with age throughout adolescence, especially in girls (USDHHS, 1996; CDC, 1997). Fourteen percent of teenage girls get no regular exercise, twice the percentage as for boys. The proportion of adolescent girls who participate in regular vigorous physical activity declines dramatically each year they are in high school, from 61 percent among 9th graders to 41percent among 12th grade girls. In high school, enrollment for girls in daily physical education classes dropped from 41 percent in 1991 to 25 percent in 1995. Both the CDC report (1997) and the Surgeon General's Report (USDHHS, 1996) recommended the need for research testing the effectiveness of a coordinated school-based physical activity intervention linked to community agency programs to increase physical activity by adolescent girls.
The study is the result of a Request for Applications released in January, 2000. Awards were made in September 2000.
DESIGN NARRATIVE:
The purpose of the multicenter randomized trial is to test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in middle school girls (i.e., in grades 6-8). The interventions will provide skills-building, supportive environments, and opportunities for participation in physical activity during and outside of the school day. Phase 1 will be 24 months for protocol development and pilot work, Phase II is 44 months for two years of intervention and one year of follow-up, and Phase III is 4 months for close out of the Study Centers, and 16 months for the Coordinating Center to collaboratively analyze and report the results.
The randomized trial of 36 middle schools (6 per field site) will collect data by two-cross sectional samples, one taken at the sixth grade (at least 1,728 girls) in the Spring of 2003 and the other taken at the eighth grade (at least 3,456 girls) in the Spring of 2005. Follow-up data collection will also occur at the eighth grade in the Spring of 2006.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Being tested
- Trial of Activity for Adolescent Girls (TAAG)
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial of Activity for Adolescent Girls (TAAG)Behavioural
Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program.
| Study group | Role | What they receive |
|---|---|---|
| School-based intervention | Experimental | TAAG health education included six lessons in each of 7th and 8th grades designed to enhance behavioral skills known to influence physical activity. TAAG physical education classes promoted moderate-vigorous physical activity for at least 50% of class time and encouraged teachers to promote physical activity outside of class. In conjunction with community partners, programs that were promoted outside of school included Dance Dance Revolution, after-school step aerobics class, before-school open gym, basketball camp, touch football, and weekend canoe programs. TAAG promotions used a social marketing approach to promote awareness of and participation in activities through media and promotional events. Receives: Behavioral: Trial of Activity for Adolescent Girls (TAAG) |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)
Measured: Post-2 year intervention
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)
Measured: Post-3 year intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2000 (estimated)
- Study startSep 2000
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,727 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, June Stevens, PhD, University of North Carolina, Chapel Hill
- Investigators
- John Elder, Principal investigator, San Diego State UniversityTimothy Lohman, Principal investigator, University of ArizonaLeslie Lytle, Principal investigator, University of MinnesotaRussell Pate, Principal investigator, University of South CarolinaJune Stevens, Principal investigator, University of North CarolinaLarry Webber, Principal investigator, Tulane UniversityDeborah Young, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006409
- Sponsor's protocol ID
- 934
- Other IDs
- U01HL066845
- Acronym
- TAAG
- Status last verified
- Jun 2015
- First submitted
- 12 Oct 2000
- Last updated
- 22 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Murray DM, Catellier DJ, Hannan PJ, Treuth MS, Stevens J, Schmitz KH, Rice JC, Conway TL. School-level intraclass correlation for physical activity in adolescent girls. Med Sci Sports Exerc. 2004 May;36(5):876-82. doi: 10.1249/01.mss.0000126806.72453.1c.
PubMed 15126724Moody JS, Prochaska JJ, Sallis JF, McKenzie TL, Brown M, Conway TL. Viability of parks and recreation centers as sites for youth physical activity promotion. Health Promot Pract. 2004 Oct;5(4):438-43. doi: 10.1177/1524839903258222.
PubMed 15358916Stevens J, Murray DM, Catellier DJ, Hannan PJ, Lytle LA, Elder JP, Young DR, Simons-Morton DG, Webber LS. Design of the Trial of Activity in Adolescent Girls (TAAG). Contemp Clin Trials. 2005 Apr;26(2):223-33. doi: 10.1016/j.cct.2004.12.011.
PubMed 15837442Dishman RK, Motl RW, Sallis JF, Dunn AL, Birnbaum AS, Welk GJ, Bedimo-Rung AL, Voorhees CC, Jobe JB. Self-management strategies mediate self-efficacy and physical activity. Am J Prev Med. 2005 Jul;29(1):10-8. doi: 10.1016/j.amepre.2005.03.012.
PubMed 15958246Schmitz KH, Treuth M, Hannan P, McMurray R, Ring KB, Catellier D, Pate R. Predicting energy expenditure from accelerometry counts in adolescent girls. Med Sci Sports Exerc. 2005 Jan;37(1):155-61. doi: 10.1249/01.mss.0000150084.97823.f7.
PubMed 15632682Treuth MS, Schmitz K, Catellier DJ, McMurray RG, Murray DM, Almeida MJ, Going S, Norman JE, Pate R. Defining accelerometer thresholds for activity intensities in adolescent girls. Med Sci Sports Exerc. 2004 Jul;36(7):1259-66.
PubMed 15235335McMurray RG, Ring KB, Treuth MS, Welk GJ, Pate RR, Schmitz KH, Pickrel JL, Gonzalez V, Almedia MJ, Young DR, Sallis JF. Comparison of two approaches to structured physical activity surveys for adolescents. Med Sci Sports Exerc. 2004 Dec;36(12):2135-43. doi: 10.1249/01.mss.0000147628.78551.3b.
PubMed 15570151Birnbaum AS, Evenson KR, Motl RW, Dishman RK, Voorhees CC, Sallis JF, Elder JP, Dowda M. Scale development for perceived school climate for girls' physical activity. Am J Health Behav. 2005 May-Jun;29(3):250-7. doi: 10.5993/ajhb.29.3.6.
PubMed 15899688Catellier DJ, Hannan PJ, Murray DM, Addy CL, Conway TL, Yang S, Rice JC. Imputation of missing data when measuring physical activity by accelerometry. Med Sci Sports Exerc. 2005 Nov;37(11 Suppl):S555-62. doi: 10.1249/01.mss.0000185651.59486.4e.
PubMed 16294118Voorhees CC, Murray D, Welk G, Birnbaum A, Ribisl KM, Johnson CC, Pfeiffer KA, Saksvig B, Jobe JB. The role of peer social network factors and physical activity in adolescent girls. Am J Health Behav. 2005 Mar-Apr;29(2):183-90. doi: 10.5993/ajhb.29.2.9.
PubMed 15698985Cohen DA, Ashwood S, Scott M, Overton A, Evenson KR, Voorhees CC, Bedimo-Rung A, McKenzie TL. Proximity to School and Physical Activity Among Middle School Girls: The Trial of Activity for Adolescent Girls Study. J Phys Act Health. 2006 Feb;3(s1):S129-S138. doi: 10.1123/jpah.3.s1.s129.
PubMed 28834509Cohen DA, Ashwood JS, Scott MM, Overton A, Evenson KR, Staten LK, Porter D, McKenzie TL, Catellier D. Public parks and physical activity among adolescent girls. Pediatrics. 2006 Nov;118(5):e1381-9. doi: 10.1542/peds.2006-1226.
PubMed 17079539Elder JP, Lytle L, Sallis JF, Young DR, Steckler A, Simons-Morton D, Stone E, Jobe JB, Stevens J, Lohman T, Webber L, Pate R, Saksvig BI, Ribisl K. A description of the social-ecological framework used in the trial of activity for adolescent girls (TAAG). Health Educ Res. 2007 Apr;22(2):155-65. doi: 10.1093/her/cyl059. Epub 2006 Jul 19.
PubMed 16855014Evenson KR, Birnbaum AS, Bedimo-Rung AL, Sallis JF, Voorhees CC, Ring K, Elder JP. Girls' perception of physical environmental factors and transportation: reliability and association with physical activity and active transport to school. Int J Behav Nutr Phys Act. 2006 Sep 14;3:28. doi: 10.1186/1479-5868-3-28.
PubMed 16972999Gittelsohn J, Steckler A, Johnson CC, Pratt C, Grieser M, Pickrel J, Stone EJ, Conway T, Coombs D, Staten LK. Formative research in school and community-based health programs and studies: "state of the art" and the TAAG approach. Health Educ Behav. 2006 Feb;33(1):25-39. doi: 10.1177/1090198105282412.
PubMed 16397157
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Activity for Adolescent Girls (TAAG)
- ClinicalTrials.gov ID
- NCT00006409
- Acronym / sponsor ID
- TAAG / 934
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,727 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2000
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Oct 2000 (estimated)
- Results
- Posted 14 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in girls in grades 6-8.
Detailed description
BACKGROUND:
The Report of the Surgeon General on Physical Activity and Health (USDHHS, 1996) emphasized that regular physical activity has important health benefits including reducing the risk of heart disease, and helping to treat and prevent high blood pressure, high cholesterol, and diabetes, and to prevent osteoporosis and colon cancer. In addition, physical activity helps control weight, reduces feelings of depression and anxiety, and promotes psychological well being. Inactivity increases with age and is more common among women than men and among those with lower income, less education, and in minorities (USDHHS, 1996). Even though adolescents are more active than adults, many do not engage in recommended levels of physical activity, and participation declines with age throughout adolescence, especially in girls (USDHHS, 1996; CDC, 1997). Fourteen percent of teenage girls get no regular exercise, twice the percentage as for boys. The proportion of adolescent girls who participate in regular vigorous physical activity declines dramatically each year they are in high school, from 61 percent among 9th graders to 41percent among 12th grade girls. In high school, enrollment for girls in daily physical education classes dropped from 41 percent in 1991 to 25 percent in 1995. Both the CDC report (1997) and the Surgeon General's Report (USDHHS, 1996) recommended the need for research testing the effectiveness of a coordinated school-based physical activity intervention linked to community agency programs to increase physical activity by adolescent girls.
The study is the result of a Request for Applications released in January, 2000. Awards were made in September 2000.
DESIGN NARRATIVE:
The purpose of the multicenter randomized trial is to test the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in middle school girls (i.e., in grades 6-8). The interventions will provide skills-building, supportive environments, and opportunities for participation in physical activity during and outside of the school day. Phase 1 will be 24 months for protocol development and pilot work, Phase II is 44 months for two years of intervention and one year of follow-up, and Phase III is 4 months for close out of the Study Centers, and 16 months for the Coordinating Center to collaboratively analyze and report the results.
The randomized trial of 36 middle schools (6 per field site) will collect data by two-cross sectional samples, one taken at the sixth grade (at least 1,728 girls) in the Spring of 2003 and the other taken at the eighth grade (at least 3,456 girls) in the Spring of 2005. Follow-up data collection will also occur at the eighth grade in the Spring of 2006.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-based intervention | Experimental | Behavioral: Trial of Activity for Adolescent Girls (TAAG)TAAG health education included six lessons in each of 7th and 8th grades designed to enhance behavioral skills known to influence physical activity. TAAG physical education classes promoted moderate-vigorous physical activity for at least 50% of class time and encouraged teachers to promote physical activity outside of class. In conjunction with community partners, programs that were promoted outside of school included Dance Dance Revolution, after-school step aerobics class, before-school open gym, basketball camp, touch football, and weekend canoe programs. TAAG promotions used a social marketing approach to promote awareness of and participation in activities through media and promotional events. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Trial of Activity for Adolescent Girls (TAAG)Intervention activities were designed to create (1) environmental and organizational changes supportive of physical activity and (2) cues, messages, and incentives to be more active. The intervention was designed to establish more opportunities, improve social support and norms, and increase self-efficacy, outcome expectations, and behavioral skills to foster greater moderate-vigorous physical activity (MVPA). An innovative feature of TAAG was linking school and community agencies to promote activity programs for girls. Finally, a TAAG Program Champion component was developed to foster sustainability after the 2-year staff-directed intervention. TAAG investigators recruited and trained Program Champions during the staff-directed intervention phase to promote maintenance of the program. | Behavioural | School-based intervention |
Primary outcome
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)
Time frame: Post-2 year intervention
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)
Time frame: Post-3 year intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15126724Murray DM, Catellier DJ, Hannan PJ, Treuth MS, Stevens J, Schmitz KH, Rice JC, Conway TL. School-level intraclass correlation for physical activity in adolescent girls. Med Sci Sports Exerc. 2004 May;36(5):876-82. doi: 10.1249/01.mss.0000126806.72453.1c.
- Background: PubMed 15358916Moody JS, Prochaska JJ, Sallis JF, McKenzie TL, Brown M, Conway TL. Viability of parks and recreation centers as sites for youth physical activity promotion. Health Promot Pract. 2004 Oct;5(4):438-43. doi: 10.1177/1524839903258222.
- Background: PubMed 15837442Stevens J, Murray DM, Catellier DJ, Hannan PJ, Lytle LA, Elder JP, Young DR, Simons-Morton DG, Webber LS. Design of the Trial of Activity in Adolescent Girls (TAAG). Contemp Clin Trials. 2005 Apr;26(2):223-33. doi: 10.1016/j.cct.2004.12.011.
- Background: PubMed 15958246Dishman RK, Motl RW, Sallis JF, Dunn AL, Birnbaum AS, Welk GJ, Bedimo-Rung AL, Voorhees CC, Jobe JB. Self-management strategies mediate self-efficacy and physical activity. Am J Prev Med. 2005 Jul;29(1):10-8. doi: 10.1016/j.amepre.2005.03.012.
- Background: PubMed 15632682Schmitz KH, Treuth M, Hannan P, McMurray R, Ring KB, Catellier D, Pate R. Predicting energy expenditure from accelerometry counts in adolescent girls. Med Sci Sports Exerc. 2005 Jan;37(1):155-61. doi: 10.1249/01.mss.0000150084.97823.f7.
- Background: PubMed 15235335Treuth MS, Schmitz K, Catellier DJ, McMurray RG, Murray DM, Almeida MJ, Going S, Norman JE, Pate R. Defining accelerometer thresholds for activity intensities in adolescent girls. Med Sci Sports Exerc. 2004 Jul;36(7):1259-66.
- Results publication: PubMed 15570151McMurray RG, Ring KB, Treuth MS, Welk GJ, Pate RR, Schmitz KH, Pickrel JL, Gonzalez V, Almedia MJ, Young DR, Sallis JF. Comparison of two approaches to structured physical activity surveys for adolescents. Med Sci Sports Exerc. 2004 Dec;36(12):2135-43. doi: 10.1249/01.mss.0000147628.78551.3b.
- Results publication: PubMed 15899688Birnbaum AS, Evenson KR, Motl RW, Dishman RK, Voorhees CC, Sallis JF, Elder JP, Dowda M. Scale development for perceived school climate for girls' physical activity. Am J Health Behav. 2005 May-Jun;29(3):250-7. doi: 10.5993/ajhb.29.3.6.
- Results publication: PubMed 16294118Catellier DJ, Hannan PJ, Murray DM, Addy CL, Conway TL, Yang S, Rice JC. Imputation of missing data when measuring physical activity by accelerometry. Med Sci Sports Exerc. 2005 Nov;37(11 Suppl):S555-62. doi: 10.1249/01.mss.0000185651.59486.4e.
- Results publication: PubMed 15698985Voorhees CC, Murray D, Welk G, Birnbaum A, Ribisl KM, Johnson CC, Pfeiffer KA, Saksvig B, Jobe JB. The role of peer social network factors and physical activity in adolescent girls. Am J Health Behav. 2005 Mar-Apr;29(2):183-90. doi: 10.5993/ajhb.29.2.9.
- Results publication: PubMed 28834509Cohen DA, Ashwood S, Scott M, Overton A, Evenson KR, Voorhees CC, Bedimo-Rung A, McKenzie TL. Proximity to School and Physical Activity Among Middle School Girls: The Trial of Activity for Adolescent Girls Study. J Phys Act Health. 2006 Feb;3(s1):S129-S138. doi: 10.1123/jpah.3.s1.s129.
- Results publication: PubMed 17079539Cohen DA, Ashwood JS, Scott MM, Overton A, Evenson KR, Staten LK, Porter D, McKenzie TL, Catellier D. Public parks and physical activity among adolescent girls. Pediatrics. 2006 Nov;118(5):e1381-9. doi: 10.1542/peds.2006-1226.
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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.
John Elder principal investigator
San Diego State University
Timothy Lohman principal investigator
University of Arizona
Leslie Lytle principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trial of Activity for Adolescent Girls (TAAG) in people with Cardiovascular Diseases and Heart Diseases, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (time frame: Post-2 year intervention). The study lists 2 primary outcomes in all. 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 NCT00006409, which also lists 39 linked publications.
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 22 Jul 2015.