Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
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|ClinicalTrials.gov Identifier: NCT01442415|
Recruitment Status : Terminated (Unable to achieve enrollment goal.)
First Posted : September 28, 2011
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Lifestyle modification||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Weekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling
Behavioral: Lifestyle modification
Weekly lifestyle modification sessions including dietary counseling and physical activity
- Change in Peak VO2 at 10 Weeks [ Time Frame: 10 week ]Change in level of physical fitness
- Change in BMI at 10 Weeks [ Time Frame: 10 week ]Change in body mass index
- Change in Systolic Blood Pressure at 10 Weeks [ Time Frame: 10 week ]
- Change in Waist Circumference at 10 Weeks [ Time Frame: 10 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442415
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Aaron S. Kelly, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|