The Collateral Impact of Bariatric Surgery on Families (Collateral)

October 20, 2016 updated by: Geisinger Clinic
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Pre-operatively, post-operatively 6 months and 12 months
Pre-operatively, post-operatively 6 months and 12 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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