NCT02160834

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
6 months 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

June 1, 2014

Enrollment Period

11 months

First QC Date

June 9, 2014

Last Update Submit

March 19, 2015

Conditions

Obesity

Keywords

Sedentary behaviorPhysical activityObesityMobile healthSmartphoneTime spent sedentary

Outcome Measures

Primary Outcomes (1)

  • Change in percentage of daily sedentary time from baseline to post-intervention.

    8 weeks

Secondary Outcomes (1)

  • Change in percentage of daily sedentary time from baseline to follow-up

    12 weeks

Study Arms (3)

B-MOBILE smartphone-based intervention (3-min break)

EXPERIMENTAL

Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."

Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break)

B-MOBILE Smartphone-Based Intervention (6-min break)

EXPERIMENTAL

Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."

Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break)

Control

NO INTERVENTION

Interventions

B-MOBILE Smartphone-Based Intervention (3-min break)BEHAVIORAL

Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."

B-MOBILE smartphone-based intervention (3-min break)
B-MOBILE Smartphone-Based Intervention (6-min break)BEHAVIORAL

Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."

B-MOBILE Smartphone-Based Intervention (6-min break)

Eligibility Criteria

Age21 Years - 70 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 \>= 25 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

MeSH Terms

Conditions

ObesitySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Dale S Bond, PhD

    The Miriam Hospital/Brown Alpert Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 11, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 24, 2015

Record last verified: 2014-06

Locations

US(1)