Mother and Child Health Outcomes After Maternal Bariatric Surgery

September 25, 2023 updated by: University of Nebraska

Prospective: Mother and Child Health Outcomes After Maternal Bariatric Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mother-Child with Intervention
Children will attend presurgical visits with their mother
Behavioral: Presurgical Counseling
Children will attend the presurgical counseling visits with their mother
Other Names:
  • No Intervention
No Intervention: Mother-Child Non-Intervention
Children will not attend presurgical visits with their mother

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal weight loss
Time Frame: presurgical, 3 mos, 6 mos
Weight loss
presurgical, 3 mos, 6 mos
Child weight loss
Time Frame: presurgical, 3 mos, 6 mos
weight loss
presurgical, 3 mos, 6 mos

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Activity level
Time Frame: presurgical, 3 mos, 6 mos
activity level
presurgical, 3 mos, 6 mos
Child Activity Level
Time Frame: presurgical, 3 mos, 6 mos
activity level
presurgical, 3 mos, 6 mos
Maternal diet
Time Frame: presurgical, 3 mos, 6 mos
Self-reported diet
presurgical, 3 mos, 6 mos
Child diet
Time Frame: presurgical, 3 mos, 6 mos
self-reported diet
presurgical, 3 mos, 6 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tiffany Tanner, MD, UNMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0821-17-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data will not be made available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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