OverweightNCT01442415
Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
A study testing Lifestyle modification in people with Overweight and Obesity, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle modification
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Weekly lifestyle modification sessions including dietary counseling and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | Other | Weekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak VO2 at 10 Weeks
Change in level of physical fitness
Measured: 10 week
Secondary outcomes (3)
Change in BMI at 10 Weeks
Change in body mass index
Measured: 10 week
Change in Systolic Blood Pressure at 10 Weeks
Measured: 10 week
Change in Waist Circumference at 10 Weeks
Measured: 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Unable to achieve enrollment goal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron S. Kelly, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442415
- Sponsor's protocol ID
- 1104M98872
- Status last verified
- Oct 2012
- First submitted
- 30 Aug 2011
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vikings Fitness Playbook: A Family Based Lifestyle Modification Program for Overweight and Obese Youth
- ClinicalTrials.gov ID
- NCT01442415
- Acronym / sponsor ID
- 1104M98872
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to achieve enrollment goal.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | Other | Behavioral: Lifestyle modificationWeekly 2 hour study sessions for 10 weeks; each session includes one hour of physical activity and one hour of dietary counseling |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modificationWeekly lifestyle modification sessions including dietary counseling and physical activity | Behavioural | Lifestyle Modification |
Primary outcome
Change in Peak VO2 at 10 Weeks
Time frame: 10 week
Change in level of physical fitness
3 secondary outcomes
Change in BMI at 10 Weeks
Time frame: 10 week
Change in Systolic Blood Pressure at 10 Weeks
Time frame: 10 week
Change in Waist Circumference at 10 Weeks
Time frame: 10 week
Results and safety
The study was stopped early (reason given: Unable to achieve enrollment goal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron S. Kelly, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Overweight and Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to achieve enrollment goal.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak VO2 at 10 Weeks (time frame: 10 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.