Overview

This trial has been completed.

Conditions obesity, bariatric surgery candidate, weight loss
Treatment outcomes
Sponsor Geisinger Clinic
Start date December 2012
End date July 2016
Trial size 97 participants
Trial identifier NCT02021630, 2012-0360, SRC-L-15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model family-based
Time perspective prospective
Arm
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
outcomes
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.

Primary Outcomes

Measure
Weight
time frame: Pre-operatively, post-operatively 6 months and 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Collateral Impact of Bariatric Surgery on Families
Principal investigator Christopher D Still, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Geisinger Clinic.