FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01394705
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Risk High	Device: BodyMedia	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care standard of care (office provider exercise counseling)
Experimental: Intervention The intervention group received a personalized exercise prescription (using the FITT principles) and wore an accelerometer up to 7days/week (most waking hours) and logged their activity by regularly (3 times a week) uploading the device for a period of 3 months, use of the internet was supervised by a parent or guardian. Their activity was monitored via the online BodyMedia site on a regular basis by study personnel and feedback was provided at least once a week through email and/or phone calls	Device: BodyMedia; Accelerometer

Outcome Measures

Primary Outcome Measures

1. Physical Activity [Baseline, 3 months]

   Total time (minutes) in Physical Activity in one week

Secondary Outcome Measures

1. Body Mass Index [Baseline, 3 months]

   Secondary hypotheses include greater improvement in body mass index (BMI) reported below.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

• Principal Investigator: Tracy c Curran, MS, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 25, 2011

More Information

Publications

None provided.

• Responsible Party: Tracy Curran, Clinical Exercise Physiologist, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01394705
• Other Study ID Numbers: P00000416
• First Posted: Jul 14, 2011
• Last Update Posted: May 29, 2019
• Last Verified: May 1, 2019

• Keywords provided by Tracy Curran, Clinical Exercise Physiologist, Boston Children's Hospital: patients at increased risk for atherosclerosis
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease

Study Results

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.

Arm/Group Title	Standard of Care	Intervention
Arm/Group Description	BodyMedia: Accelerometer	BodyMedia: Accelerometer
Period Title: Overall Study
STARTED	21	21
COMPLETED	19	19
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Standard of Care	Intervention	Total
Arm/Group Description	BodyMedia: Accelerometer	BodyMedia: Accelerometer	Total of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	16 84.2%	17 89.5%	33 86.8%
Between 18 and 65 years	3 15.8%	2 10.5%	5 13.2%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	15.7	15.9	15.8
Sex: Female, Male (Count of Participants)
Female	8 42.1%	7 36.8%	15 39.5%
Male	11 57.9%	12 63.2%	23 60.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15.8%	2 10.5%	5 13.2%
Not Hispanic or Latino	15 78.9%	16 84.2%	31 81.6%
Unknown or Not Reported	1 5.3%	1 5.3%	2 5.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5.3%	0 0%	1 2.6%
White	14 73.7%	19 100%	33 86.8%
More than one race	1 5.3%	0 0%	1 2.6%
Unknown or Not Reported	3 15.8%	0 0%	3 7.9%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	Physical Activity
Description	Total time (minutes) in Physical Activity in one week
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Intervention
Arm/Group Description	office provider exercise counseling	BodyMedia: Accelerometer wear
Measure Participants	19	19
Baseline	457	443
Follow-up	364	279

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.65
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Body Mass Index
Description	Secondary hypotheses include greater improvement in body mass index (BMI) reported below.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Intervention
Arm/Group Description	office provider exercise counseling	BodyMedia: Accelerometer
Measure Participants	19	19
Baseline	30	33
Follow up	30	32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Study participant data was collected for 3 months.
Arm/Group Title	Standard of Care		Intervention
Arm/Group Description	BodyMedia: Accelerometer		BodyMedia: Accelerometer
All Cause Mortality
	Standard of Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Serious Adverse Events
	Standard of Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.