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Middle School Physical Activity Intervention for Girls

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351649
First Posted: May 11, 2011
Last Update Posted: September 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lorraine Robbins, Michigan State University
May 9, 2011
May 11, 2011
September 18, 2015
April 2009
June 2010   (Final data collection date for primary outcome measure)
Minutes of moderate to vigorous physical activity [ Time Frame: baseline and 6 months ]
Same as current
Complete list of historical versions of study NCT01351649 on ClinicalTrials.gov Archive Site
  • self-report of moderate to vigorous physical activity [ Time Frame: baseline and 6 months ]
  • cardiovascular fitness [ Time Frame: baseline and 6 months ]
  • Body mass index (BMI) [ Time Frame: baseline and 6 months ]
  • percent body fat [ Time Frame: baseline and 6 months ]
  • waist circumference [ Time Frame: baseline and 6 months ]
Same as current
Not Provided
Not Provided
 
Middle School Physical Activity Intervention for Girls
Middle School Physical Activity Intervention for Girls

Specific aims are:

  1. Evaluate the feasibility of the intervention related to (1) girls' participation; (2) adherence to protocols; and (3) user and provider (nurse and PA Club instructors) satisfaction.
  2. Explore if participants in the intervention group, compared to those in the control group, show improvement in the primary outcome of minutes of moderate to vigorous physical activity (MVPA; measured by accelerometer), and also secondary outcomes of self-report of MVPA, cardiovascular fitness, body mass index, percent body fat, and waist circumference at 6 months.
  3. Explore if the primary outcome is mediated by cognitive (perceived benefits of PA, perceived barriers to PA,PA self-efficacy, social support, norms, models) and affective (enjoyment of PA) variables.
  4. Explore if participants in the intervention group, compared to those in the control group, have greater minutes of MVPA at 7 months.
The purpose of this study is to test the feasibility of and obtain preliminary evidence of efficacy for a 6-month "Girls on the Move" intervention (guided by the Health Promotion Model and Social Cognitive Theory). The intervention involves motivational, individually tailored counseling plus after-school physical activity (PA) to increase moderate to vigorous physical activity (MVPA) and cardiovascular (CV) fitness, as well as improve body composition and cognition and affective responses related to MVPA among 6th-grade girls. Specifically, it consists of a 90-minute after-school PA Club that includes MVPA and 6 one-on-one monthly motivational, individually tailored counseling sessions with a registered (school) nurse during the school day to support each girl's continued MVPA. Applying the motivational interviewing communication style, the school nurse will individually tailor the counseling based upon each girl's key responses gleaned from computerized questionnaires assessing cognitive and affective variables related to MVPA. One middle school will be randomly assigned to receive the intervention and another to serve as attention control.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Physical Activity
Behavioral: middle school physical activity intervention for girls
Both the "Girls on the Move" intervention and attention control conditions will involve 2 components: face-to-face (individual) counseling sessions with a school nurse and an after-school (group) program. The intervention for the attention control group will not address physical activity. Both groups will respond to questionnaires at 0 (baseline) and 6 mos. Our "Girls on the Move" intervention is designed to help girls achieve physical activity recommendations (≥ 60 min. ≥ 5 days/wk.). The motivational, individually tailored counseling sessions with a school nurse and after-school physical activity club (3-5 times a wk. for 6 mos.) are designed to positively influence all cognitive and affective mediating variables of the Health Promotion Model.
  • attention control
    Sessions with school nurse to discuss health-promoting topics and after-school health-promoting workshop. Physical activity and healthy eating were not addressed.
    Intervention: Behavioral: middle school physical activity intervention for girls
  • Experimental: physical activity
    Intervention: Behavioral: middle school physical activity intervention for girls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

(1) 6th-grade girls (ages 10-12) (7th-graders if needed; up to and including age 14) who report not meeting national MVPA recommendations; (2) available and willing to participate 6 mos.; and (3) able to read, understand, and speak English (e.g., school nurse checks that girl is reading at grade level or enrolled in remedial course).

Exclusion criteria:

(1) Involved in school or community sports or other organized PAs or lessons, such as dance, martial arts, gymnastics, or tennis, that involve MVPA and require participation 3 or more days/wk. during every season of the school year; and (2) a health condition limiting or precluding safe MVPA.

Sexes Eligible for Study: Female
10 Years to 14 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01351649
R21HL090705( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Lorraine Robbins, Michigan State University
Michigan State University
Not Provided
Principal Investigator: Lorraine B Robbins, PhD Michigan State University
Michigan State University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP