The Collateral Impact of Bariatric Surgery on Families

Obesity Clinical Trial

— Collateral  

Official title:

The Collateral Impact of Bariatric Surgery on Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021630
• Other study ID #: 2012-0360
• Secondary ID: SRC-L-15
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: October 20, 2016
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Weight Loss

Intervention

Other:
• Outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.

Locations

Country	Name	City	State
United States	Geisinger Clinic	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory outcomes	Lipid panel, insulin, glucose	Pre-operatively, post-operatively 6 months and 12 months	No
Other	Questionnaires	Home Food Inventory, Social Support	Pre-operatively, post-operatively 6 months and 12 months	No
Primary	Weight		Pre-operatively, post-operatively 6 months and 12 months	No
Secondary	Percent body fat		Pre-operatively, post-operatively 6 months and 12 months	No
Secondary	Physical Activity	Accelerometer	Pre-operatively, post-operatively 6 months and 12 months	No