The Collateral Impact of Bariatric Surgery on Families

NCT02021630 | Completed

• 2 other identifiers: 2012-0360SRC-L-15
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Bariatric Surgery Candidate; Weight Loss

Keywords

Obesity; Bariatric Surgery; Weight Loss; Physical Activity; Body Composition

Outcome Measures

Primary Outcomes (1)

• Weight

  Pre-operatively, post-operatively 6 months and 12 months

Secondary Outcomes (2)

• Percent body fat

  Pre-operatively, post-operatively 6 months and 12 months

• Physical Activity

  Pre-operatively, post-operatively 6 months and 12 months

Other Outcomes (2)

• Laboratory outcomes

  Pre-operatively, post-operatively 6 months and 12 months

• Questionnaires

  Pre-operatively, post-operatively 6 months and 12 months

Study Arms (3)

Patient

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

Other: Outcomes

Spouse/Partner

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

Other: Outcomes

Child(ren)

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

Other: Outcomes

Interventions

Outcomes OTHER

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

Child(ren); Patient; Spouse/Partner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822-2111, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Interventions

Treatment Outcome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Christopher D Still, DO

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-07

Locations

US (1)