The Collateral Impact of Bariatric Surgery on Families

NCT ID: NCT02021630

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Bariatric Surgery Candidate Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient

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

Outcomes

Intervention Type OTHER

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.

Outcomes

Intervention Type OTHER

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.

Outcomes

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Outcomes

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher D Still, DO

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SRC-L-15

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0360

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.