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N/A Completed N=40 Randomized Prevention

TAME Health: Testing Activity Monitors' Effect on Health

Physical Activity
Source: ClinicalTrials.gov NCT02554435 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Physical Activity Minutes Measured by a SenseWear Armband — 40.2; 33.8 minutes per day

Summary

Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.

Outcome Measures

OutcomeResultp-value
PRIMARY
Physical Activity Minutes Measured by a SenseWear Armband
40.2; 33.8 —
PRIMARY
Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
21.2; 16.6 —
PRIMARY
6-minute Walk Test
1642.9; 1561 —
PRIMARY
Steps Per Day
4702; 4353 —
SECONDARY
Weight
86.8; 81.9 —
SECONDARY
Body Mass Index (BMI)
30.5; 30.0 —
SECONDARY
Waist-to-Hip Ratio
.84; 0.80 —
SECONDARY
Blood Pressure
134.3; 125.0; 83.4; 80 —
SECONDARY
Exercise Motivation
1.48; 2.84; 2.24; 2.92; 1.12; 1.68 —
SECONDARY
Quality of Life Measured by the SF-36 Questionnaire
62.3; 73.1; 75.8; 71.3; 67.9; 72.2 —
SECONDARY
Physical Function Measured by the Short Physical Performance Battery
14.2; 14.7; 9.2; 9.1; 5.9; 6.4 —
SECONDARY
Psychological Feelings
2.49; 3.43; 3.16; 4.01; 2.72; 3.53 —
SECONDARY
Resting Pulse
76.5; 69.1 —
SECONDARY
Change From Baseline in Self-regulation
22.1; 31.3; 24.3; 26.4 —

Eligibility Criteria

Inclusion Criteria

  • physically inactive (less than 60 minutes per week)
  • BMI between 25-35
  • in good health measured by Par-Q+
  • access to a smart phone

Exclusion Criteria

  • physical activity is inadvisable by their doctor
  • involved in another physical activity intervention within the past 6 months
  • used an activity monitor in the past 6 months
  • unwilling to travel for scheduled visits
  • currently taking medications that affect body composition
  • current smoker
  • report alcohol or drug problem
  • institutionalized for psychiatric illness within the last year
  • do not consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02554435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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