Middle School Physical Activity Intervention for Girls

NCT01351649 | Completed Phase 1 DMC

• 1 other identifier: R21HL090705
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims are:

1. 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. 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. 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. 4.Explore if participants in the intervention group, compared to those in the control group, have greater minutes of MVPA at 7 months.

Conditions

Physical Activity

Keywords

exercise; adolescent; intervention; female; counseling

Outcome Measures

Primary Outcomes (1)

• Minutes of moderate to vigorous physical activity

  baseline and 6 months

Secondary Outcomes (5)

• self-report of moderate to vigorous physical activity

  baseline and 6 months

• cardiovascular fitness

  baseline and 6 months

• Body mass index (BMI)

  baseline and 6 months

• percent body fat

  baseline and 6 months

• waist circumference

  baseline and 6 months

Study Arms (2)

attention control

OTHER

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

physical activity

EXPERIMENTAL

Behavioral: middle school physical activity intervention for girls

Interventions

middle school physical activity intervention for girls 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.

attention control; physical activity

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (3)

• 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.

  PMID: 22472632 RESULT

• 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.

  PMID: 21970862 RESULT

• 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.

  PMID: 25027734 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lorraine B Robbins, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 11, 2011
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)