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Mother and Child Health Outcomes After Maternal Bariatric Surgery

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Presurgical Counseling
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 19-55 at the time of surgery
  2. Consent to provide access to medical records for medical history
  3. Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine
  4. Have children ages 8-17 (at the time of the mother's surgery) living in the home
  5. Consent to wear an activity tracker device for 7 days after designated visits.

Exclusion Criteria:

  1. Complication of bariatric procedure post-operatively that would significantly affect weight loss (extended period of TPN, clinically significant leak, major organ failure, severe protein malnutrition or failure to thrive)
  2. Body contouring within the first year (panniculectomy, etc.).
  3. Are pregnant or become pregnant during the study

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mother-Child with Intervention

Mother-Child Non-Intervention

Arm Description

Children will attend presurgical visits with their mother

Children will not attend presurgical visits with their mother

Outcomes

Primary Outcome Measures

Maternal weight loss
Weight loss
Child weight loss
weight loss

Secondary Outcome Measures

Maternal Activity level
activity level
Child Activity Level
activity level
Maternal diet
Self-reported diet
Child diet
self-reported diet

Full Information

First Posted
July 26, 2017
Last Updated
September 25, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03297307
Brief Title
Mother and Child Health Outcomes After Maternal Bariatric Surgery
Official Title
Prospective: Mother and Child Health Outcomes After Maternal Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Childhood obesity has been a growing problem with more than 30% of children between 6 and 19 years old being considered overweight or obese. Obese children are at increased risk of developing diabetes, heart disease, metabolic syndrome, and are susceptible to the sociological effects of being overweight. Obesity is a multifactorial disease, is often familial and multi-generational, and studies have shown that parental obesity can increase the risk of a child becoming obese. Currently, one of the most successful treatment options for obesity is bariatric surgery. The Nebraska Medicine Bariatric Center offers patients counseling in improved dietary management, methods to increase physical activity, and psychological support. As part of the programs standard-of-care, each bariatric surgical patient receives consultation with a dietician, psychologist, and an exercise physiologist. We propose that mothers who are enrolled in the surgical weight loss program bring their children to attend the presurgical specialist consultation. Subjects enrolled in the study will have their height, weight, and physical activity assessed at preoperative and postoperative study visits. Study subjects will also complete questionnaires of their self-reported physical activity and eating habits at these study visits. The goal of this pilot study is to examine whether this behavioral intervention will have an impact on the overall health and weight of children whose mothers have received bariatric surgery.
Detailed Description
This is a prospective intervention study of female bariatric surgical patients and their children. The dyads, consisting of one female bariatric patients and one child living in the home, will be enrolled in the study. Half of the children will attend the dietary, physical activity, and psychological counseling with the mother prior to her surgery, and the other half of the children will not receive the behavioral intervention. Outcomes from each mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively (Visit BL-2, Visit PO-3, and Visit PO-6). The primary outcome measured from each dyad will be BMI, and secondary outcomes will be physical activity and energy expenditure (as measured by an accelerometer at each research study visit) and self-reported diet and physical activity (as measured by questionnaires completed at each research study visit). Each bariatric surgical patient will receive a consultation with a dietician, psychologist, and an exercise physiologist as standard-of-care. These specialist consultations usually take place sequentially in the same day. The intervention aspect of this study is to include the child with the mother for these specialist consultations. The dietician will educate the patient as to dietary modifications that will be needed both before and after bariatric surgery. The psychologist will review any existing psychological conditions with the patient and discuss behavioral and pharmaceutical management of these conditions in conjunction with the bariatric surgery. The exercise physiologist will discuss physical restrictions to exercise and modifications to an exercise regimen that can be properly performed by the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective intervention study of female bariatric surgical patients and their children. The dyads, consisting of one female bariatric patients and one child living in the home, will be enrolled in the study. Half of the children will attend the dietary, physical activity, and psychological counseling with the mother prior to her surgery, and the other half of the children will not receive the behavioral intervention. Outcomes from each mother-child dyad will be measured at baseline, and 3 and 6 months postoperatively
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mother-Child with Intervention
Arm Type
Experimental
Arm Description
Children will attend presurgical visits with their mother
Arm Title
Mother-Child Non-Intervention
Arm Type
No Intervention
Arm Description
Children will not attend presurgical visits with their mother
Intervention Type
Behavioral
Intervention Name(s)
Presurgical Counseling
Other Intervention Name(s)
No Intervention
Intervention Description
Children will attend the presurgical counseling visits with their mother
Primary Outcome Measure Information:
Title
Maternal weight loss
Description
Weight loss
Time Frame
presurgical, 3 mos, 6 mos
Title
Child weight loss
Description
weight loss
Time Frame
presurgical, 3 mos, 6 mos
Secondary Outcome Measure Information:
Title
Maternal Activity level
Description
activity level
Time Frame
presurgical, 3 mos, 6 mos
Title
Child Activity Level
Description
activity level
Time Frame
presurgical, 3 mos, 6 mos
Title
Maternal diet
Description
Self-reported diet
Time Frame
presurgical, 3 mos, 6 mos
Title
Child diet
Description
self-reported diet
Time Frame
presurgical, 3 mos, 6 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 19-55 at the time of surgery Consent to provide access to medical records for medical history Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine Have children ages 8-17 (at the time of the mother's surgery) living in the home Consent to wear an activity tracker device for 7 days after designated visits. Exclusion Criteria: Complication of bariatric procedure post-operatively that would significantly affect weight loss (extended period of TPN, clinically significant leak, major organ failure, severe protein malnutrition or failure to thrive) Body contouring within the first year (panniculectomy, etc.). Are pregnant or become pregnant during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Tanner, MD
Organizational Affiliation
UNMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be made available to other researchers

Learn more about this trial

Mother and Child Health Outcomes After Maternal Bariatric Surgery

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