Go Girls! Fitness Support Group Intervention Effectiveness Study

NCT ID: NCT02117063

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2024-12-31

Brief Summary

The main purpose of this study is to determine if the Go Girls! program to take place at the Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to introduce girls to a fun, non-threatening environment of exercise with peer support, improves scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of physical activity before and after the program will allow objective evaluation of whether the program is achieving its mission. Qualitative responses to the questionnaires will give program leaders a better sense of potential attitudes and barriers to regular exercise for teen girls. These responses will be used to shape activities during this or future programs for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk factors can be seen from this 6-month once weekly intervention.

Detailed Description

Adolescent girls have low participation in physical activity compared to boys at all ages. Interventions to improve physical activity levels in children have shown greatest success when targeted to low-active adolescent girls and employ strategies to enhance adolescents' enjoyment of physical activity. Go Girls! is a new dance-based patient fitness support group being offered via the Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic for girls at-risk for weight-related medical complications, particularly those with excess weight, polycystic ovary syndrome (PCOS), diabetes mellitus, or insulin resistance. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls with similar health concerns, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers. The primary aim of this study is to determine changes in girls' enjoyment of exercise. Our hypothesis is that introducing girls to a fun, non-threatening environment of exercise with peer support will modify scores on a physical activity enjoyment scale. Secondary aims will assess for changes in weekly exercise, attitudes about exercise, and metabolic parameters and evidence for androgen (male hormone) excess (a precursor to PCOS). Subjects will be recruited from girls already participating in the Go Girls! program. Go Girls! is open to girls ages 10-18 yr with diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus previously cared for by the Pediatric Endocrinology or Children's Fitness Clinics. Questionnaire, anthropometric, and optional fasting biochemical information will be collected from girls at the beginning (first month), middle (third month), and end of a 6-month exercise/support group intervention. Assessment of the primary aim will be by comparing scores on the validated Physical Activity Enjoyment Scale (PACES) compared before, during and after the intervention. Secondary aims will be assessed via self-reported estimates of weekly exercise, qualitative written assessments of attitudes towards exercise, and changes in biochemical data. Data obtained from the questionnaire will be used to assess the primary aim of this protocol. The biochemical information, obtained via optional blood draws at the beginning, middle, and end of the 6-month exercise/support group intervention will be used to address one of the secondary aims. These blood draws are optional so as not to deter subjects from participating in the main part of the study. Data from the questionnaire and anthropometric measurements will be useful for testing the primary and some of the secondary aims of this study, regardless of whether or not fasting biochemical information is obtained.

Conditions

Polycystic Ovary Syndrome; Abnormal Weight Gain; Excess Weight; Insulin Resistance; Premature Adrenarche; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Go Girls! Fitness Support Group

Group Type: EXPERIMENTAL

Go Girls! Fitness Support Group

Intervention Type: BEHAVIORAL

Go Girls! is a dance-based patient fitness support group offered by the University of Virginia Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic at the University of Virginia for girls. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers.

Interventions

Go Girls! Fitness Support Group

Go Girls! is a dance-based patient fitness support group offered by the University of Virginia Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic at the University of Virginia for girls. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• Ages 10-18 yr
• Participating in the Go Girls! program
• With diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus

Exclusion Criteria

• Known pregnancy

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Christine Burt Solorzano

Assistant Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Burt Solorzano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Center for Research in Reproduction, University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Gilrain

Role: CONTACT

pcos@virginia.edu

434-243-6911

Christine Burt Solorzano, MD

Role: CONTACT

cmb6w@virginia.edu

434-924-9084

Facility Contacts

Melissa Gilrain

Role: primary

pcos@virginia.edu

434-243-6911

Christine M Burt Solorzano, MD

Role: backup

pcos@virginia.edu

434-924-9084

Other Identifiers

U54HD028934-18

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16132

Identifier Type: -

Identifier Source: org_study_id