Coronary Artery Disease Risk High
Conditions
Keywords
patients at increased risk for atherosclerosis
Brief summary
This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar patients receiving Frequency, Intensity, Time, Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an online interactive tool. The investigators primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of the investigators patients over standard of care provider counseling. The investigators Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.
Interventions
DEVICEBodyMedia
Accelerometer
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol \> 199 mg/dL, High Density Lipoprotein \< 40 mg/dL, LDL \> 129 mg/dL, blood pressure (Systolic Blood Pressure or Diastolic Blood Pressure \> 90th percentile), obesity (\>85%Body Mass Index) 2. Ages 13-21 years 3. Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week. 4. Regular access to the internet with the capacity to download the device 5. Commitment on the part of a parent to supervise internet access as part of this protocol
Exclusion criteria
1. Unable to exercise based on physician recommendations or medical conditions 2. Unable/unwilling to complete requirements of the research study including consent and assent. 3. Not proficient in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | Baseline, 3 months | Total time (minutes) in Physical Activity in one week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline, 3 months | Secondary hypotheses include greater improvement in body mass index (BMI) reported below. |
Countries
United States
Participant flow
Recruitment details
38 completed study, 21 randomized to each group, 2 lost to follow-up in each group with an N of 19 in each group.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care BodyMedia: Accelerometer | 19 |
| Intervention BodyMedia: Accelerometer | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Standard of Care | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 15.7 years | 15.9 years | 15.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 19 Participants | 33 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Physical Activity
Total time (minutes) in Physical Activity in one week
Time frame: Baseline, 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care | Physical Activity | Baseline | 457 minutes per week |
| Standard of Care | Physical Activity | Follow-up | 364 minutes per week |
| Intervention | Physical Activity | Baseline | 443 minutes per week |
| Intervention | Physical Activity | Follow-up | 279 minutes per week |
p-value: 0.65Fisher Exact
p-value: 0.65Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index
Secondary hypotheses include greater improvement in body mass index (BMI) reported below.
Time frame: Baseline, 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard of Care | Body Mass Index | Baseline | 30 BMI (kg/m2) |
| Standard of Care | Body Mass Index | Follow up | 30 BMI (kg/m2) |
| Intervention | Body Mass Index | Baseline | 33 BMI (kg/m2) |
| Intervention | Body Mass Index | Follow up | 32 BMI (kg/m2) |
p-value: 0.76Wilcoxon (Mann-Whitney)