Study Stopped
Unable to achieve enrollment goal.
Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 24, 2012
October 1, 2012
1 year
August 30, 2011
October 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Peak VO2 at 10 Weeks
Change in level of physical fitness
10 week
Secondary Outcomes (3)
Change in BMI at 10 Weeks
10 week
Change in Systolic Blood Pressure at 10 Weeks
10 week
Change in Waist Circumference at 10 Weeks
10 week
Study Arms (1)
Lifestyle Modification
OTHERWeekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling
Interventions
Weekly lifestyle modification sessions including dietary counseling and physical activity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron S. Kelly, Ph.D.
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 28, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 24, 2012
Record last verified: 2012-10