ObesityCollateralNCT02021630
The Collateral Impact of Bariatric Surgery on Families
An observational study of Obesity and Bariatric Surgery Candidate, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Weight Loss
- What is being tested?
- Outcomes
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Obesity, Bariatric Surgery Candidate, Weight Loss
- Being tested
- Outcomes
- Keywords
- Obesity, Bariatric Surgery, Weight Loss, Physical Activity, Body Composition
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutcomesOther
No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patient | No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. Receives: Other: Outcomes | |
| Spouse/Partner | No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. Receives: Other: Outcomes | |
| Child(ren) | No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. Receives: Other: Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Pre-operatively, post-operatively 6 months and 12 months
Secondary outcomes (2)
Percent body fat
Measured: Pre-operatively, post-operatively 6 months and 12 months
Physical Activity
Accelerometer
Measured: Pre-operatively, post-operatively 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher D Still, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021630
- Sponsor's protocol ID
- 2012-0360
- Other IDs
- SRC-L-15
- Acronym
- Collateral
- Status last verified
- Jul 2016
- First submitted
- 20 Dec 2013
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collateral Impact of Bariatric Surgery on Families
- ClinicalTrials.gov ID
- NCT02021630
- Acronym / sponsor ID
- Collateral / 2012-0360
- Conditions
- Obesity, Bariatric Surgery Candidate, Weight Loss
- Keywords
- Obesity, Bariatric Surgery, Weight Loss, Physical Activity, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: OutcomesNo intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. |
| Spouse/Partner | – | Other: OutcomesNo intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. |
| Child(ren) | – | Other: OutcomesNo intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutcomesNo intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery. | Other | Child(ren), Patient, Spouse/Partner |
Primary outcome
Weight
Time frame: Pre-operatively, post-operatively 6 months and 12 months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Still, DO principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Pre-operatively, post-operatively 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.