Middle School Physical Activity Intervention for Girls

Physical Activity Clinical Trial

Official title:

Middle School Physical Activity Intervention for Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351649
• Other study ID #: R21HL090705
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 9, 2011
• Last updated: September 17, 2015
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2015
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Robbins LB, Pfeiffer KA, Maier KS, Ladrig SM, Berg-Smith SM. Treatment fidelity of motivational interviewing delivered by a school nurse to increase girls' physical activity. J Sch Nurs. 2012 Feb;28(1):70-8. doi: 10.1177/1059840511424507. Epub 2011 Oct 4. — View Citation

Robbins LB, Pfeiffer KA, Maier KS, Lo YJ, Wesolek Ladrig SM. Pilot intervention to increase physical activity among sedentary urban middle school girls: a two-group pretest-posttest quasi-experimental design. J Sch Nurs. 2012 Aug;28(4):302-15. doi: 10.117 — View Citation

Vanden Bosch ML, Robbins LB, Pfeiffer KA, Kazanis AS, Maier KS. Demographic, cognitive, affective, and behavioral variables associated with overweight and obesity in low-active girls. J Pediatr Nurs. 2014 Nov-Dec;29(6):576-85. doi: 10.1016/j.pedn.2014.06. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of moderate to vigorous physical activity		baseline and 6 months	No
Secondary	self-report of moderate to vigorous physical activity		baseline and 6 months	No
Secondary	cardiovascular fitness		baseline and 6 months	No
Secondary	Body mass index (BMI)		baseline and 6 months	No
Secondary	percent body fat		baseline and 6 months	No
Secondary	waist circumference		baseline and 6 months	No