NCT00962325

Brief Summary

For the growing number of severely obese individuals, there are currently few effective long-term weight control options with the exception of bariatric surgery. However, behavioral factors including low physical activity can undermine successful surgical outcomes. This study will compare the effects of a behavioral physical activity intervention with a standard care control condition on changes in physical activity among inactive adult bariatric surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 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

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

5.1 years

First QC Date

August 19, 2009

Last Update Submit

March 14, 2016

Conditions

Physical ActivityWeight LossHealth-related Quality of Life

Keywords

Physical activityObesityBariatric surgeryWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Changes in MVPA minutes, bout-related (occurring in bouts of 10 minutes or longer) and total

    6-week Post-intervention follow-up

Secondary Outcomes (5)

  • Change in MVPA, bout-related and total

    3- and 6-month postoperative follow-up

  • Changes in health-related quality of life

    6-week Post-intervention follow-up, 3- and 6-month postoperative follow-up

  • Changes in physical activity self-efficacy and outcome expectations

    Post-intervention follow-up, 3- and 6-month postoperative follow-up

  • Changes in physical activity enjoyment

    Post-intervention, 3- and 6-month postoperative follow-up

  • Weight

    post-intervention follow-up, 3- and 6-months postoperative

Study Arms (2)

Activity behaviors counseling

EXPERIMENTAL
Behavioral: Intervention to increase physical activity

Standard care control

NO INTERVENTION

6 weeks of standard preoperative care

Interventions

Intervention to increase physical activityBEHAVIORAL

This will be a 6-week preoperative intervention to increase structured walking activity. This will be accomplished through weekly individual face-to-face sessions involving tailored instruction in use of standard behavior change strategies such as self-monitoring, goal-setting, stimulus control, etc.

Activity behaviors counseling

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI equal to or greater than 40 or greater than or equal to 35 (in presence of significant comorbidities)
  • Have elected to undergo Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding
  • Able to engage in activities of daily living
  • Currently inactive, defined as less than 150 weekly minutes of moderate-to-vigorous physical activity in bouts of 10 minutes or more
  • Obtainment of written consent from surgeon to participate

You may not qualify if:

  • Unable to engage in activities of daily living
  • Report conditions that would render the participant unlikely to follow the study protocol (e.g., relocation, substance abuse, severe psychiatric condition)
  • Inability to understand program instructions due to language barrier or a mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • Bond DS, Raynor HA, Thomas JG, Unick J, Webster J, Ryder B, Vithiananthan S. Greater Adherence to Recommended Morning Physical Activity is Associated With Greater Total Intervention-Related Physical Activity Changes in Bariatric Surgery Patients. J Phys Act Health. 2017 Jun;14(6):492-498. doi: 10.1123/jpah.2016-0529. Epub 2017 Mar 2.

    PMID: 28253045DERIVED

  • Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, Pohl D, Ryder BA, Roye GD, Sax HC, Wing RR. Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):169-77. doi: 10.1016/j.soard.2014.07.010. Epub 2014 Jul 30.

    PMID: 25304832DERIVED

MeSH Terms

Conditions

Motor ActivityWeight LossObesity

Condition Hierarchy (Ancestors)

BehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2014

Study Completion

June 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

US(1)