The Collateral Impact of Bariatric Surgery on Families (Collateral)

• ClinicalTrials.gov Identifier: NCT02021630
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Last Update Posted: October 21, 2016
• Sponsor: Geisinger Clinic
• 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

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

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

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