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


N/A
8 Years
16 Years
Not Enrolling
Both
Overweight, Obesity

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Trial Information

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


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:

1. 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.

2. 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Peak VO2 at 10 Weeks

Outcome Description:

Change in level of physical fitness

Outcome Time Frame:

10 week

Safety Issue:

No

Principal Investigator

Aaron S. Kelly, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Institutional Review Board

Study ID:

1104M98872

NCT ID:

NCT01442415

Start Date:

October 2011

Completion Date:

October 2012

Related Keywords:

  • Overweight
  • Obesity
  • Obesity
  • Overweight

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455