Mother and Child Health Outcomes After Maternal Bariatric Surgery

NCT03297307 | Completed

• 1 other identifier: 0821-17-EP
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

• Maternal weight loss

  Weight loss

  presurgical, 3 mos, 6 mos

• Child weight loss

  weight loss

  presurgical, 3 mos, 6 mos

Secondary Outcomes (4)

• Maternal Activity level

  presurgical, 3 mos, 6 mos

• Child Activity Level

  presurgical, 3 mos, 6 mos

• Maternal diet

  presurgical, 3 mos, 6 mos

• Child diet

  presurgical, 3 mos, 6 mos

Study Arms (2)

Mother-Child with Intervention

EXPERIMENTAL

Children will attend presurgical visits with their mother

Behavioral: Presurgical Counseling

Mother-Child Non-Intervention

NO INTERVENTION

Children will not attend presurgical visits with their mother

Interventions

Presurgical Counseling BEHAVIORAL

Children will attend the presurgical counseling visits with their mother

Also known as: No Intervention

Mother-Child with Intervention

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiffany Tanner, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: September 29, 2017
• Study Start: January 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 2, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)