NCT01688804

Brief Summary

Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

September 17, 2012

Last Update Submit

March 19, 2015

Conditions

Sedentary Behavior

Keywords

Sedentary behaviorPhysical activityObesityMobile healthSmartphone

Outcome Measures

Primary Outcomes (1)

  • Average daily sedentary minutes

    4 weeks

Secondary Outcomes (1)

  • Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone

    4 weeks

Study Arms (1)

Behavioral intervention

EXPERIMENTAL

Behavioral intervention to reduce sedentary time delivered via mobile smartphone

Behavioral: Behavioral intervention to reduce sedentary time delivered via mobile smartphone

Interventions

Behavioral intervention to reduce sedentary time delivered via mobile smartphoneBEHAVIORAL

The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.

Behavioral intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bariatric surgery patients and other obese individuals will be considered
  • Body mass index \>= 30 kg/m2

You may not qualify if:

  • Report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance
  • Are currently involved in a physical activity intervention.
  • Are unable to read or understand the study materials
  • Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
  • Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Bond DS, Thomas JG, Raynor HA, Moon J, Sieling J, Trautvetter J, Leblond T, Wing RR. B-MOBILE--a smartphone-based intervention to reduce sedentary time in overweight/obese individuals: a within-subjects experimental trial. PLoS One. 2014 Jun 25;9(6):e100821. doi: 10.1371/journal.pone.0100821. eCollection 2014.

    PMID: 24964010DERIVED

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dale S Bond, Ph.D.

    The Miriam Hospital/Brown Alpert Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 24, 2015

Record last verified: 2012-09

Locations

US(1)