Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Collateral Impact of Bariatric Surgery on Families (Collateral)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021630
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This proposal is designed to examine the impact of bariatric surgery on the health of patients and their families. The shared environment of spouses/cohabitating partners suggests that patients' families are exposed to the extensive diet and lifestyle changes required of patients following bariatric surgery.

Condition or disease Intervention/treatment
Obesity Bariatric Surgery Candidate Weight Loss Other: Outcomes

Detailed Description:

The specific aims of this proposal are to:

  1. Collect clinical data (e.g., weight, blood pressure, body composition, blood sample), as well as monitor physical activity and eating patterns, before and after bariatric surgery (Adults Only).
  2. Analyze clinical data, physical activity and eating patterns to determine how the health of patients and their families change after one family member completes bariatric surgery (Adults Only).
  3. Determine the feasibility of recruiting patients, spouses/partners and their children.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: The Collateral Impact of Bariatric Surgery on Families
Study Start Date : December 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patient
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
 Other: Outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
Spouse/Partner
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
 Other: Outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
Child(ren)
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
 Other: Outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]

Secondary Outcome Measures :
  1. Percent body fat [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
  2. Physical Activity [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Accelerometer


Other Outcome Measures:
  1. Laboratory outcomes [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Lipid panel, insulin, glucose

  2. Questionnaires [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Home Food Inventory, Social Support


Biospecimen Retention:   Samples Without DNA
urine

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in the bariatric surgery program at Geisinger Medical Center's Center for Nutrition and Weight Management along with their spouse/partner and/or child(ren) ages 5-16.
Criteria

Inclusion Criteria:

  • All patients who receive surgery have been cleared medically and psychosocially for surgery. Thus, surgical candidacy criteria will serve as eligibility criteria for the current study for surgical patients.
  • Cohabitation with patients will be considered inclusion criteria for partners/spouses.
  • Children between the ages of ≥5 - ≤ 16, who cohabitate with the patient the majority of the time will be asked to participate by providing assent.

Exclusion Criteria:

  • Report current or planned use of weight loss medications (including OTC), or other weight loss strategy.
  • Report pregnancy, lactation, or plans to become pregnant during study duration.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021630


Locations
Layout table for location information
United States, Pennsylvania
Geisinger Clinic
Danville, Pennsylvania, United States, 17822-2111
Sponsors and Collaborators
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: Christopher D Still, DO Geisinger Clinic
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT02021630    
Other Study ID Numbers: 2012-0360
SRC-L-15 ( Registry Identifier: Geisinger's Scientific Review Committee )
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Geisinger Clinic:
Obesity
Bariatric Surgery
Weight Loss
Physical Activity
Body Composition
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight
Body Weight Changes