Parent-Based Intervention Following a Weight Loss Surgery

NCT ID: NCT04247113

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-12-31

Brief Summary

Prevention and early intervention are the most effective methods for influencing eating habits. This study helps fulfill the Department of Psychiatry's missions of clinical innovation and advancing science. Findings will inform future clinical practice, improve the care provided to patients in their important role as parents, and foster interdisciplinary collaborations.

Detailed Description

Morbid obesity is both highly heritable and affected by environmental factors. The child of a parent undergoing a weight-loss surgery (PWLS) is at especially high risk of obesity. The most effective approach to reducing the risk of childhood obesity is a parent-based program. However, adherence remains a challenge, largely due to lack of tailored interventions. Typical interventions are not individualized to target the unique characteristics of the family nor timed to be delivered when the family is geared for change. Parent-Based Prevention following a bariatric surgery (PBP-B) is a novel targeted intervention that focuses on parental behaviors important for developing healthy eating and lifestyle behaviors in young children. PBP-B personalizes treatment goals through a focused parent-based approach that includes a family meal. Additionally, PBP-B is timed to capitalize on the Halo Effect period, in which the BMIs of the family members of the person undergoing weight loss surgery reduce spontaneously, yet only temporarily.

This study will investigate whether PBP-B is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of obesity (e.g., parental feeding practices, child eating behaviors, child physical activity levels, and child sleep hours). Ten adults who had weight loss surgery and are the parents of one or more children aged 1-10 will receive PBP-B (with their partners, unless they are single parents). This study will collect important pilot data that will inform the design of future adequately powered studies to test ways to reduce the likelihood of adult obesity in children of a parent who had weight loss surgery.

Conditions

Obesity; Obesity, Childhood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PBP-B

Parent-based Prevention following a Bariatric Surgery (PBP-B) is a 6-session parent-based program designed to guide parents who have undergone a weight loss surgery and their partners in developing healthy eating habits in their children

Group Type: EXPERIMENTAL

Parent-based prevention following bariatric surgery

Intervention Type: BEHAVIORAL

PBP-B is an adapted version of Parent-Based Prevention (PBP), an innovative approach with demonstrated efficacy in targeting the familial effects of parents with eating disorders on their young children's healthy behaviors. PBP-B addresses the parental cognitions and behaviors that putatively increase the risk for maladaptive outcomes in their children.

Interventions

Parent-based prevention following bariatric surgery

PBP-B is an adapted version of Parent-Based Prevention (PBP), an innovative approach with demonstrated efficacy in targeting the familial effects of parents with eating disorders on their young children's healthy behaviors. PBP-B addresses the parental cognitions and behaviors that putatively increase the risk for maladaptive outcomes in their children.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The biological parent of a child between 1-10 years of age.
• Has undergone a weight loss surgery.

Exclusion Criteria

• Current medical condition necessitating more intensive care to manage symptoms.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

James Dale Lock

Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debra L Safer, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Shiri Sadeh-Sharvit, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

James Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

36281

Identifier Type: -

Identifier Source: org_study_id