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The Collateral Impact of Bariatric Surgery on Families (Collateral)

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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

Tracking Information
First Submitted Date December 20, 2013
First Posted Date December 27, 2013
Last Update Posted Date October 21, 2016
Study Start Date December 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2013)
Weight [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2013)
  • Percent body fat [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
  • Physical Activity [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Accelerometer
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2013)
  • Laboratory outcomes [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Lipid panel, insulin, glucose
  • Questionnaires [ Time Frame: Pre-operatively, post-operatively 6 months and 12 months ]
    Home Food Inventory, Social Support
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Collateral Impact of Bariatric Surgery on Families
Official Title The Collateral Impact of Bariatric Surgery on Families
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.
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 Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine
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.
Condition
  • Obesity
  • Bariatric Surgery Candidate
  • Weight Loss
Intervention Other: Outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
Study Groups/Cohorts
  • Patient
    No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
    Intervention: Other: Outcomes
  • Spouse/Partner
    No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
    Intervention: Other: Outcomes
  • Child(ren)
    No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
    Intervention: Other: Outcomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 20, 2016)
97
Original Estimated Enrollment
 (submitted: December 20, 2013)
150
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02021630
Other Study ID Numbers 2012-0360
SRC-L-15 ( Registry Identifier: Geisinger's Scientific Review Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Geisinger Clinic
Study Sponsor Geisinger Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Christopher D Still, DO Geisinger Clinic
PRS Account Geisinger Clinic
Verification Date July 2016