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Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Survivor of childhood cancer for ≥5 years (N = 24) and no history of childhood cancer (N = 24)
  • Age 8-16 years old at the time of consent
  • BMI ≥ 85th percentile or waist circumference ≥ 85th percentile for age and gender

Exclusion Criteria:

  • Exercise/physical activity contraindicated
  • Initiation of a new drug therapy within the past 30 days prior to study commencement
  • Current (within 3 months of study commencement) use of weight loss medication(s)
  • History of weight loss surgery
  • Obesity from a genetic cause (e.g., Prader-Willi)
  • Central nervous system injury or severe neurological impairment
  • Known systolic or diastolic dysfunction or heart failure

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lifestyle Modification

Arm Description

Weekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling

Outcomes

Primary Outcome Measures

Change in Peak VO2 at 10 Weeks
Change in level of physical fitness

Secondary Outcome Measures

Change in BMI at 10 Weeks
Change in body mass index
Change in Systolic Blood Pressure at 10 Weeks
Change in Waist Circumference at 10 Weeks

Full Information

First Posted
August 30, 2011
Last Updated
October 22, 2012
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01442415
Brief Title
Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
Official Title
Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
Unable to achieve enrollment goal.
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Childhood cancer survivors (CCS) are prone to develop obesity and are at increased risk of developing cardiovascular disease and type 2 diabetes compared to the general pediatric population. Few lifestyle modification trials have been conducted in overweight/obese CCS and it is unclear whether CCS respond similarly to lifestyle modification compared to overweight/obese individuals who have not had cancer (non-CCS). We propose a 3-year pilot study that will enroll separate cohorts of overweight/obese CCS and overweight/obese non-CCS every September into a family-based lifestyle modification program consisting of weekly sessions at the University of Minnesota. The goal of the program will be to facilitate improved physical fitness, weight management, heart health, and quality of life.
Detailed Description
Advances in cancer detection and treatment over the last few decades have led to a marked increase in survival rates in children and adolescents diagnosed with cancer. As a result, the number of CCS has burgeoned and continues to grow. Unfortunately, damage to multiple physiological systems often occurs when many of these effective, yet toxic, cancer therapies are used. In particular, radiation and chemotherapy are thought to promote an environment favorable to obesity, atherosclerosis, and impaired glucose metabolism. More specifically, the cardiometabolic risk factor profile in CCS is characterized by abdominal obesity, dyslipidemia, hypertension, and impaired glucose metabolism/insulin resistance. Excess adiposity in adolescence and young adulthood, even in otherwise healthy individuals who have not had cancer, is associated with increased risk for CVD and T2DM. Moreover, longitudinal data uniformly implicate obesity early in life as a strong predictor of future risk factor clustering and vascular abnormalities in later adulthood. Therefore, obesity in adolescence and young adulthood, even in those without a history of cancer, is associated with greatly increased risk of CVD and T2DM. The risk is likely further compounded when obesity is present in the context of cancer survivorship. Lifestyle modification is the preferred approach for reducing the risk of developing CVD and T2DM in CCS. However, few studies have been conducted in this area and none have assessed multiple physiological outcomes. Furthermore no studies have evaluated the response to lifestyle modification in overweight/obese CCS vs. overweight/obese non-CCS. It is possible that because the cancer therapies are responsible for the increased risk in CCS (and not necessarily behavioral habits), CCS may respond less-favorably to lifestyle modification compared to overweight/obese non-CCS. Therefore, the purpose of this pilot study will be to evaluate the effect of a 10-week family-based lifestyle modification program on cardiovascular and metabolic health in overweight and obese children who have survived childhood cancers of all types and overweight and obese children who have not had cancer. SPECIFIC AIMS The following specific aims will be addressed in this pilot study: Evaluate the effect of a 10-week family-based lifestyle modification program on physical fitness in overweight/obese children who have survived childhood cancer and overweight/obese children who have not had cancer. We hypothesize that compared to overweight/obese non-CCS children, overweight/obese CCS who engage in a 10-week family-based lifestyle modification program will have an attenuated improvement in peak V02. Evaluate the effect of a 10-week family-based lifestyle modification program on body weight, waist circumference, blood pressure, lipids, artery health, and quality of life in overweight/obese children who have survived childhood cancer and overweight/obese children who have not had cancer. We hypothesize that compared to overweight/obese non-CCS children, overweight/obese CCS who engage in a 10-week family-based lifestyle modification program will have attenuated improvements in body weight, waist circumference, blood pressure, lipids, artery health, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Modification
Arm Type
Other
Arm Description
Weekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
Weekly lifestyle modification sessions including dietary counseling and physical activity
Primary Outcome Measure Information:
Title
Change in Peak VO2 at 10 Weeks
Description
Change in level of physical fitness
Time Frame
10 week
Secondary Outcome Measure Information:
Title
Change in BMI at 10 Weeks
Description
Change in body mass index
Time Frame
10 week
Title
Change in Systolic Blood Pressure at 10 Weeks
Time Frame
10 week
Title
Change in Waist Circumference at 10 Weeks
Time Frame
10 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Survivor of childhood cancer for ≥5 years (N = 24) and no history of childhood cancer (N = 24) Age 8-16 years old at the time of consent BMI ≥ 85th percentile or waist circumference ≥ 85th percentile for age and gender Exclusion Criteria: Exercise/physical activity contraindicated Initiation of a new drug therapy within the past 30 days prior to study commencement Current (within 3 months of study commencement) use of weight loss medication(s) History of weight loss surgery Obesity from a genetic cause (e.g., Prader-Willi) Central nervous system injury or severe neurological impairment Known systolic or diastolic dysfunction or heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron S. Kelly, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth

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