Middle School Physical Activity Intervention for Girls

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorraine Robbins, Michigan State University
ClinicalTrials.gov Identifier:
NCT01351649
First received: May 9, 2011
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Physical Activity
Behavioral: middle school physical activity intervention for girls
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Middle School Physical Activity Intervention for Girls

Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Minutes of moderate to vigorous physical activity [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-report of moderate to vigorous physical activity [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • cardiovascular fitness [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • percent body fat [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351649

Locations
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Lorraine B Robbins, PhD Michigan State University
  More Information

Publications:
Responsible Party: Lorraine Robbins, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01351649     History of Changes
Other Study ID Numbers: R21HL090705
Study First Received: May 9, 2011
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
exercise
adolescent
intervention
female
counseling

ClinicalTrials.gov processed this record on July 28, 2014