The Collateral Impact of Bariatric Surgery on Families

Completed

• Conditions: Obesity; Bariatric Surgery Candidate; Weight Loss
• Interventions: Other: Outcomes

• Registration Number: NCT02021630
• Lead Sponsor: Geisinger Clinic

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Weight	Pre-operatively, post-operatively 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Percent body fat	Pre-operatively, post-operatively 6 months and 12 months
Physical Activity	Pre-operatively, post-operatively 6 months and 12 months	Accelerometer

Trial Locations

Locations (1)

Geisinger Clinic; 🇺🇸 Danville, Pennsylvania, United States