Skip to main content
OpenTrials
Completed

NCT Number: NCT02021630

The Collateral Impact of Bariatric Surgery on Families

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Bariatric Surgery Candidate Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822-2111, United States

About this study

The specific aims of this proposal are to:

  • 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).
  • 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).
  • Determine the feasibility of recruiting patients, spouses/partners and their children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Outcomes

Other

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

Primary outcomes

  1. Weight

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

Secondary outcomes

  1. Percent body fat

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

  2. Physical Activity

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

    Accelerometer

Other outcomes

  1. Laboratory outcomes

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

    Lipid panel, insulin, glucose

  2. Questionnaires

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

    Home Food Inventory, Social Support

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Acronym: Collateral

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.