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Go Girls! Fitness Support Group Intervention Effectiveness Study (CBS002)

Primary Purpose

Polycystic Ovary Syndrome, Abnormal Weight Gain, Excess Weight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go Girls! Fitness Support Group
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

10 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Research in Reproduction, University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Go Girls! Fitness Support Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in mean score for the PACES scale after 3-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.
Change in amounts of average daily moderate-vigorous exercise
Amounts of average daily moderate-vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing moderate-vigorous physical activity.
Change in amounts of average daily vigorous exercise
Amounts of average daily vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing vigorous physical activity
Changes in attitudes about exercise
Responses will be compiled into descriptive summaries/themes of girls' attitudes before, during, and after the intervention
Changes in anthropometric and biochemical indices of metabolism and possible PCOS
We will be assessing changes in blood pressure, body mass index total and percentile-for-age, waist circumference, serum markers of androgen excess and/or PCOS (free testosterone calculated from total testosterone and sex hormone binding globulin, dehydroepiandrosterone sulfate, and luteinizing hormone: follicle stimulation hormone ratio), serum markers of insulin resistance (insulin, glucose, HbA1c), and lipid abnormalities (HDL, LDL, triglycerides)

Full Information

First Posted
April 15, 2014
Last Updated
July 28, 2022
Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02117063
Brief Title
Go Girls! Fitness Support Group Intervention Effectiveness Study
Acronym
CBS002
Official Title
Go Girls! Fitness Support Group Intervention Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Abnormal Weight Gain, Excess Weight, Insulin Resistance, Premature Adrenarche, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Go Girls! Fitness Support Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Go Girls! Fitness Support Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean score for the PACES scale after 6-months of intervention
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in mean score for the PACES scale after 3-months of intervention
Description
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.
Time Frame
Baseline and 3 months
Title
Change in amounts of average daily moderate-vigorous exercise
Description
Amounts of average daily moderate-vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing moderate-vigorous physical activity.
Time Frame
Baseline, 3 months, and 6 months
Title
Change in amounts of average daily vigorous exercise
Description
Amounts of average daily vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing vigorous physical activity
Time Frame
Baseline, 3 months, and 6 months
Title
Changes in attitudes about exercise
Description
Responses will be compiled into descriptive summaries/themes of girls' attitudes before, during, and after the intervention
Time Frame
Baseline, 3 months, 6 months
Title
Changes in anthropometric and biochemical indices of metabolism and possible PCOS
Description
We will be assessing changes in blood pressure, body mass index total and percentile-for-age, waist circumference, serum markers of androgen excess and/or PCOS (free testosterone calculated from total testosterone and sex hormone binding globulin, dehydroepiandrosterone sulfate, and luteinizing hormone: follicle stimulation hormone ratio), serum markers of insulin resistance (insulin, glucose, HbA1c), and lipid abnormalities (HDL, LDL, triglycerides)
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Gilrain
Phone
434-243-6911
Email
pcos@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Burt Solorzano, MD
Phone
434-924-9084
Email
cmb6w@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Burt Solorzano, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research in Reproduction, University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Gilrain
Phone
434-243-6911
Email
pcos@virginia.edu
First Name & Middle Initial & Last Name & Degree
Christine M Burt Solorzano, MD
Phone
434-924-9084
Email
pcos@virginia.edu
First Name & Middle Initial & Last Name & Degree
Christine M Burt Solorzano, MD

12. IPD Sharing Statement

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Go Girls! Fitness Support Group Intervention Effectiveness Study

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