Go Girls! Fitness Support Group Intervention Effectiveness Study

NCT02117063 | Unknown

• 2 other identifiers: 16132U54HD028934-18
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in mean score for the PACES scale after 6-months of intervention

  Enjoyment of exercise will be assessed by scores on the PACES modified for adolescent girls, which is scored on a scale of 1 to 5.

  Baseline and 6 months

Secondary Outcomes (5)

• Change in mean score for the PACES scale after 3-months of intervention

  Baseline and 3 months

• Change in amounts of average daily moderate-vigorous exercise

  Baseline, 3 months, and 6 months

• Change in amounts of average daily vigorous exercise

  Baseline, 3 months, and 6 months

• Changes in attitudes about exercise

  Baseline, 3 months, 6 months

• Changes in anthropometric and biochemical indices of metabolism and possible PCOS

  Baseline, 3 months, 6 months

Study Arms (1)

Go Girls! Fitness Support Group

EXPERIMENTAL

Behavioral: Go Girls! Fitness Support Group

Interventions

Go Girls! Fitness Support Group 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.

Go Girls! Fitness Support Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Known pregnancy

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Research in Reproduction, University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus

Study Officials

• Christine Burt Solorzano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Gilrain

CONTACT

434-243-6911; pcos@virginia.edu

Christine Burt Solorzano, MD

CONTACT

434-924-9084; cmb6w@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)