NCT02005042

Brief Summary

Lack of physical activity is associated with negative health outcomes, including obesity, diabetes, and cardiovascular disease. There are calls from NIH and medical organizations to integrate the use mobile devices, such as smartphones, to provide "e-health" interventions to patients in their daily life. Referred to as Ecological Momentary Interventions \[EMI\], these innovative mobile methods provide an opportunity for researchers and clinicians to offer tailored intervention material to people at specific times and in specific settings when they may be most in need of such support. To our knowledge no study has used objective ambulatory assessment data to deliver EMI. This preliminary work is to demonstrate the feasibility, and test preliminary efficacy, of using a Bluetooth accelerometer to provide real-time feedback on a smartphone to increase objectively measured steps (i.e., increase activity). A within-person design will be used, including assessment, intervention, and follow-up phases. During the assessment phase objective physical activity (using accelerometers) will be collected. In the intervention phase participants will also receive real-time feedback throughout the day regarding their total steps and personalized step goals. Objectively measured steps and disease status measures will be used to evaluate efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

November 22, 2013

Last Update Submit

November 21, 2017

Conditions

Physical Activity

Keywords

Physical activityEcological Momentary AssessmentEcological Momentary InterventionAccelerometerSmartphone

Outcome Measures

Primary Outcomes (1)

  • Number of steps

    during intervention (~28 days)

Secondary Outcomes (4)

  • BMI

    Baseline, Post-intervention

  • blood pressure

    Baseline

  • Hemoglobin A1c

    Baseline

  • waist-hip ratio

    Baseline

Other Outcomes (10)

  • Perceived Stress

    Baseline, Post-intervention

  • Depression

    Baseline, Post-intervention

  • Social Support

    Baseline, Post-intervention

  • +7 more other outcomes

Study Arms (3)

Accelerometer only

NO INTERVENTION

Wear accelerometer only to measure activity levels (steps)

Accelerometer plus EMA

NO INTERVENTION

Wear accelerometer and complete Ecological Momentary Assessment (EMA) surveys on smartphone 5 times daily

Feedback on smartphone

EXPERIMENTAL

Wear accelerometer, complete EMA surveys on smartphone 5 times daily, receive intervention

Behavioral: Feedback on smartphone

Interventions

Feedback on smartphoneBEHAVIORAL

Receive personalized feedback (EMI) on smartphone regarding physical activity

Feedback on smartphone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • English literate
  • A BMI ranging from 25-40 (overweight or obese), based on self-report height and weight
  • Not meeting current national physical activity guidelines
  • Self-report they are able to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
  • Medically cleared to participate by completing screening form
  • For women: not currently pregnant or actively trying to get pregnant for duration of study

You may not qualify if:

  • Younger than 18
  • Not English literate
  • Self-report they are unable to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
  • Meeting current national physical activity guidelines
  • Not medically cleared to participate
  • For women: currently pregnant or actively trying to get pregnant for duration of study. Pregnant women or those trying to become pregnant will be excluded because pregnancy may interfere with women's ability to go about previously normal activities, and will influence our outcome measures (e.g., BMI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kristin Heron, Ph.D.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 9, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)