The Collateral Impact of Bariatric Surgery on Families (Collateral)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Bariatric Surgery Candidate
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2111
      • Geisinger Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight	Pre-operatively, post-operatively 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent body fat		Pre-operatively, post-operatively 6 months and 12 months
Physical Activity	Accelerometer	Pre-operatively, post-operatively 6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory outcomes	Lipid panel, insulin, glucose	Pre-operatively, post-operatively 6 months and 12 months
Questionnaires	Home Food Inventory, Social Support	Pre-operatively, post-operatively 6 months and 12 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Christopher D Still, DO, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Weight Loss; Body Composition; Bariatric Surgery
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2012-0360; SRC-L-15 (Registry Identifier: Geisinger's Scientific Review Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED