Parent-Based Intervention Following a Weight Loss Surgery (PBP-B)
Primary Purpose
Obesity, Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-based prevention following bariatric surgery
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring bariatric surgery, Parent-based prevention
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PBP-B
Arm Description
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
Outcomes
Primary Outcome Measures
Feasibility of recruiting parents who have undergone a bariatric surgery
Number of eligible participants that agree to participate in the study
Acceptability of the intervention
Client Satisfaction Questionnaire score at end of treatment
Secondary Outcome Measures
Parental feeding practices
Change scores of the Child Feeding Questionnaire from baseline to end of treatment
Child eating behaviors
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04247113
Brief Title
Parent-Based Intervention Following a Weight Loss Surgery
Acronym
PBP-B
Official Title
Assessing the Feasibility and Acceptability of a Parent-Based Intervention to Reduce the Risk of Obesity in Children of Weight Loss Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Childhood
Keywords
bariatric surgery, Parent-based prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBP-B
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Parent-based prevention following bariatric surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruiting parents who have undergone a bariatric surgery
Description
Number of eligible participants that agree to participate in the study
Time Frame
Up to 18 months
Title
Acceptability of the intervention
Description
Client Satisfaction Questionnaire score at end of treatment
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Parental feeding practices
Description
Change scores of the Child Feeding Questionnaire from baseline to end of treatment
Time Frame
Baseline and Week 8
Title
Child eating behaviors
Description
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment
Time Frame
Baseline and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L Safer, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shiri Sadeh-Sharvit, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Lock, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Parent-Based Intervention Following a Weight Loss Surgery
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