Middle School Physical Activity Intervention for Girls

NCT ID: NCT01351649

Last Updated: 2015-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

middle school physical activity intervention for girls

Intervention Type BEHAVIORAL

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.

physical activity

Group Type EXPERIMENTAL

middle school physical activity intervention for girls

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Lorraine Robbins

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorraine B Robbins, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

References

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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: 10.1177/1059840512438777. Epub 2012 Apr 3.

Reference Type RESULT
PMID: 22472632 (View on PubMed)

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.

Reference Type RESULT
PMID: 21970862 (View on PubMed)

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.2014.06.002. Epub 2014 Jun 17.

Reference Type RESULT
PMID: 25027734 (View on PubMed)

Other Identifiers

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R21HL090705

Identifier Type: NIH

Identifier Source: org_study_id

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