ObesityNCT00250497
New Moves - Obesity Prevention Among Adolescent Girls
A study testing New Moves in people with Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- New Moves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2009
- Phase
- Interventional
- 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 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school girls
- Low levels of physical activity - defined as being in precontemplation, contemplation, or preparation stages of change for physical activity with activity levels at, or below, 30 minutes per day/three days per week outside of school physical education class
- Priority will be given to girls with a body mass index (BMI) greater than or equal to the 75th percentile for age and gender
Who cannot join
- BMI less than the 25th percentile for age and gender
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Division of Epidemiology and Community Health
Minneapolis, Minnesota, 55454
About this study
Official title: New Moves: Obesity Prevention Among Adolescent Girls
The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.
Read the detailed description
The purpose of the New Moves study is to evaluate the effectiveness of a school-based all girls alternative to regular physical education class for inactive high school girls. New Moves uses a large-scale community randomized controlled study involving girls from six intervention schools and six control schools. The New Moves class includes physical activity, nutritional guidance, and social support within a supportive, non-competitive environment. In addition the program includes individual counseling sessions.
The primary research hypothesis is that girls in the intervention condition will significantly decrease their percent body fat as compared to girls in the control condition. Secondary research hypothesis to be tested are that girls in the intervention condition will significantly increase their level of physical activity and improve the quality of their dietary intake as compared to girls in the control condition. In addition a range of socioenvironmental, personal, and behavioral variables will be compared across conditions.
- Conditions
- Obesity
- Being tested
- New Moves
- Keywords
- Adolescent, Girls, Physical Activity, Exercise, Diet, Body image
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New MovesBehavioural
The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach.
| Study group | Role | What they receive |
|---|---|---|
| New Moves Intervention Group | Experimental | The New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach. Receives: Behavioral: New Moves |
| control group | No intervention | Girls in the control group participated in an all-girls physical education class but did not receive additional components offered in the intervention such as individual coaching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Body Fat
Measured with DEX-A at baseline and 1 year follow-up
Measured: Baseline and One year
Secondary outcomes (5)
Level of Physical Activity
The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.
Measured: One year
Fruits and Vegetables
Measured: One year
Sedentary Activity
The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day
Measured: One Year
Unhealthy Weight Control Behaviors
Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.
Measured: One Year
Body Satisfaction
Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionJun 2009
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 (14)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dianne Neumark-Sztainer, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250497
- Sponsor's protocol ID
- 0309S51763
- Other IDs
- R01DK063107
- Status last verified
- Oct 2019
- First submitted
- 7 Nov 2005
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Neumark-Sztainer D, Flattum CF, Story M, Feldman S, Petrich CA. Dietary approaches to healthy weight management for adolescents: the New Moves model. Adolesc Med State Art Rev. 2008 Dec;19(3):421-30, viii.
PubMed 19227384Flattum C, Friend S, Neumark-Sztainer D, Story M. Motivational interviewing as a component of a school-based obesity prevention program for adolescent girls. J Am Diet Assoc. 2009 Jan;109(1):91-4. doi: 10.1016/j.jada.2008.10.003.
PubMed 19103327Neumark-Sztainer D, Bauer KW, Friend S, Hannan PJ, Story M, Berge JM. Family weight talk and dieting: how much do they matter for body dissatisfaction and disordered eating behaviors in adolescent girls? J Adolesc Health. 2010 Sep;47(3):270-6. doi: 10.1016/j.jadohealth.2010.02.001. Epub 2010 Apr 21.
PubMed 20708566Neumark-Sztainer DR, Friend SE, Flattum CF, Hannan PJ, Story MT, Bauer KW, Feldman SB, Petrich CA. New moves-preventing weight-related problems in adolescent girls a group-randomized study. Am J Prev Med. 2010 Nov;39(5):421-32. doi: 10.1016/j.amepre.2010.07.017.
PubMed 20965379Bauer KW, Neumark-Sztainer D, Fulkerson JA, Hannan PJ, Story M. Familial correlates of adolescent girls' physical activity, television use, dietary intake, weight, and body composition. Int J Behav Nutr Phys Act. 2011 Mar 31;8:25. doi: 10.1186/1479-5868-8-25.
PubMed 21453516Bauer KW, Neumark-Sztainer D, Fulkerson JA, Story M. Adolescent girls' weight-related family environments, Minnesota. Prev Chronic Dis. 2011 May;8(3):A68. Epub 2011 Apr 15.
PubMed 21477508Bauer KW, Neumark-Sztainer D, Hannan PJ, Fulkerson JA, Story M. Relationships between the family environment and school-based obesity prevention efforts: can school programs help adolescents who are most in need? Health Educ Res. 2011 Aug;26(4):675-88. doi: 10.1093/her/cyr027. Epub 2011 May 2.
PubMed 21536714Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.
PubMed 21802570Meyer KA, Demerath EW, Friend S, Hannan PJ, Neumark-Sztainer D. Body fat is differentially related to body mass index in U.S.-born African-American and East African immigrant girls. Am J Hum Biol. 2011 Sep-Oct;23(5):720-3. doi: 10.1002/ajhb.21201. Epub 2011 Jul 25.
PubMed 21793092Meyer KA, Friend S, Hannan PJ, Himes JH, Demerath EW, Neumark-Sztainer D. Ethnic variation in body composition assessment in a sample of adolescent girls. Int J Pediatr Obes. 2011 Oct;6(5-6):481-90. doi: 10.3109/17477166.2011.596841. Epub 2011 Jul 12.
PubMed 21749194Bauer KW, Friend S, Graham DJ, Neumark-Sztainer D. Beyond Screen Time: Assessing Recreational Sedentary Behavior among Adolescent Girls. J Obes. 2012;2012:183194. doi: 10.1155/2012/183194. Epub 2011 Oct 12.
PubMed 22013514Friend S, Bauer KW, Madden TC, Neumark-Sztainer D. Self-weighing among adolescents: associations with body mass index, body satisfaction, weight control behaviors, and binge eating. J Acad Nutr Diet. 2012 Jan;112(1):99-103. doi: 10.1016/j.jada.2011.08.036. Epub 2011 Nov 4.
PubMed 22717180Friend S, Flattum CF, Simpson D, Nederhoff DM, Neumark-Sztainer D. The researchers have left the building: what contributes to sustaining school-based interventions following the conclusion of formal research support? J Sch Health. 2014 May;84(5):326-33. doi: 10.1111/josh.12149.
PubMed 24707927Graham DJ, Bauer KW, Friend S, Barr-Anderson DJ, Nuemark-Sztainer D. Personal, behavioral, and socio-environmental correlates of physical activity among adolescent girls: cross-sectional and longitudinal associations. J Phys Act Health. 2014 Jan;11(1):51-61. doi: 10.1123/jpah.2011-0239. Epub 2012 Dec 17.
PubMed 23250194
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Moves: Obesity Prevention Among Adolescent Girls
- ClinicalTrials.gov ID
- NCT00250497
- Acronym / sponsor ID
- 0309S51763
- Conditions
- Obesity
- Keywords
- Adolescent, Girls, Physical Activity, Exercise, Diet, Body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Posted 3 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.
Detailed description
The purpose of the New Moves study is to evaluate the effectiveness of a school-based all girls alternative to regular physical education class for inactive high school girls. New Moves uses a large-scale community randomized controlled study involving girls from six intervention schools and six control schools. The New Moves class includes physical activity, nutritional guidance, and social support within a supportive, non-competitive environment. In addition the program includes individual counseling sessions.
The primary research hypothesis is that girls in the intervention condition will significantly decrease their percent body fat as compared to girls in the control condition. Secondary research hypothesis to be tested are that girls in the intervention condition will significantly increase their level of physical activity and improve the quality of their dietary intake as compared to girls in the control condition. In addition a range of socioenvironmental, personal, and behavioral variables will be compared across conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Moves Intervention Group | Experimental | Behavioral: New MovesThe New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach. |
| control group | No intervention | –Girls in the control group participated in an all-girls physical education class but did not receive additional components offered in the intervention such as individual coaching. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- High school girls
- Low levels of physical activity - defined as being in precontemplation, contemplation, or preparation stages of change for physical activity with activity levels at, or below, 30 minutes per day/three days per week outside of school physical education class
- Priority will be given to girls with a body mass index (BMI) greater than or equal to the 75th percentile for age and gender
Key exclusion criteria (1 listed)
- BMI less than the 25th percentile for age and gender
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 |
|---|---|---|
| New MovesThe New Moves intervention is an all girls physical education class that provides a supportive environment for girls. Girls participate in noncompetitive physical activities. They also receive lessons on nutrition and social support. After the class is over, girls continue to receive intervention messages through weekly lunch meetings. Girls meet individually with a personal coach. | Behavioural | New Moves Intervention Group |
Primary outcome
Percent Body Fat
Time frame: Baseline and One year
Measured with DEX-A at baseline and 1 year follow-up
5 secondary outcomes
Level of Physical Activity
Time frame: One year
Fruits and Vegetables
Time frame: One year
Sedentary Activity
Time frame: One Year
Unhealthy Weight Control Behaviors
Time frame: One Year
Body Satisfaction
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19227384Neumark-Sztainer D, Flattum CF, Story M, Feldman S, Petrich CA. Dietary approaches to healthy weight management for adolescents: the New Moves model. Adolesc Med State Art Rev. 2008 Dec;19(3):421-30, viii.
- Results publication: PubMed 19103327Flattum C, Friend S, Neumark-Sztainer D, Story M. Motivational interviewing as a component of a school-based obesity prevention program for adolescent girls. J Am Diet Assoc. 2009 Jan;109(1):91-4. doi: 10.1016/j.jada.2008.10.003.
- Results publication: PubMed 20708566Neumark-Sztainer D, Bauer KW, Friend S, Hannan PJ, Story M, Berge JM. Family weight talk and dieting: how much do they matter for body dissatisfaction and disordered eating behaviors in adolescent girls? J Adolesc Health. 2010 Sep;47(3):270-6. doi: 10.1016/j.jadohealth.2010.02.001. Epub 2010 Apr 21.
- Results publication: PubMed 20965379Neumark-Sztainer DR, Friend SE, Flattum CF, Hannan PJ, Story MT, Bauer KW, Feldman SB, Petrich CA. New moves-preventing weight-related problems in adolescent girls a group-randomized study. Am J Prev Med. 2010 Nov;39(5):421-32. doi: 10.1016/j.amepre.2010.07.017.
- Results publication: PubMed 21453516Bauer KW, Neumark-Sztainer D, Fulkerson JA, Hannan PJ, Story M. Familial correlates of adolescent girls' physical activity, television use, dietary intake, weight, and body composition. Int J Behav Nutr Phys Act. 2011 Mar 31;8:25. doi: 10.1186/1479-5868-8-25.
- Results publication: PubMed 21477508Bauer KW, Neumark-Sztainer D, Fulkerson JA, Story M. Adolescent girls' weight-related family environments, Minnesota. Prev Chronic Dis. 2011 May;8(3):A68. Epub 2011 Apr 15.
- Results publication: PubMed 21536714Bauer KW, Neumark-Sztainer D, Hannan PJ, Fulkerson JA, Story M. Relationships between the family environment and school-based obesity prevention efforts: can school programs help adolescents who are most in need? Health Educ Res. 2011 Aug;26(4):675-88. doi: 10.1093/her/cyr027. Epub 2011 May 2.
- Results publication: PubMed 21802570Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.
- Results publication: PubMed 21793092Meyer KA, Demerath EW, Friend S, Hannan PJ, Neumark-Sztainer D. Body fat is differentially related to body mass index in U.S.-born African-American and East African immigrant girls. Am J Hum Biol. 2011 Sep-Oct;23(5):720-3. doi: 10.1002/ajhb.21201. Epub 2011 Jul 25.
- Results publication: PubMed 21749194Meyer KA, Friend S, Hannan PJ, Himes JH, Demerath EW, Neumark-Sztainer D. Ethnic variation in body composition assessment in a sample of adolescent girls. Int J Pediatr Obes. 2011 Oct;6(5-6):481-90. doi: 10.3109/17477166.2011.596841. Epub 2011 Jul 12.
- Results publication: PubMed 22013514Bauer KW, Friend S, Graham DJ, Neumark-Sztainer D. Beyond Screen Time: Assessing Recreational Sedentary Behavior among Adolescent Girls. J Obes. 2012;2012:183194. doi: 10.1155/2012/183194. Epub 2011 Oct 12.
- Results publication: PubMed 22717180Friend S, Bauer KW, Madden TC, Neumark-Sztainer D. Self-weighing among adolescents: associations with body mass index, body satisfaction, weight control behaviors, and binge eating. J Acad Nutr Diet. 2012 Jan;112(1):99-103. doi: 10.1016/j.jada.2011.08.036. Epub 2011 Nov 4.
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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.
Dianne Neumark-Sztainer, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Moves in people with Obesity, run by University of Minnesota 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 3 inclusion and 1 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 1 Nov 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2015). 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?
Percent Body Fat (time frame: Baseline and One year). 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 NCT00250497, which also lists 14 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 1 Nov 2019.