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NCT Number: NCT03297307

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.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Presurgical Counseling

Behavioral

Children will attend the presurgical counseling visits with their mother

Other names: No Intervention

Primary outcomes

  1. Maternal weight loss

    Time frame: presurgical, 3 mos, 6 mos

    Weight loss

  2. Child weight loss

    Time frame: presurgical, 3 mos, 6 mos

    weight loss

Secondary outcomes

  1. Maternal Activity level

    Time frame: presurgical, 3 mos, 6 mos

    activity level

  2. Child Activity Level

    Time frame: presurgical, 3 mos, 6 mos

    activity level

  3. Maternal diet

    Time frame: presurgical, 3 mos, 6 mos

    Self-reported diet

  4. Child diet

    Time frame: presurgical, 3 mos, 6 mos

    self-reported diet

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Prospective: Mother and Child Health Outcomes After Maternal Bariatric Surgery

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2017
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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