NCT04247113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 23, 2020

Last Update Submit

January 27, 2020

Conditions

Keywords

bariatric surgeryParent-based prevention

Outcome Measures

Primary Outcomes (2)

  • Feasibility of recruiting parents who have undergone a bariatric surgery

    Number of eligible participants that agree to participate in the study

    Up to 18 months

  • Acceptability of the intervention

    Client Satisfaction Questionnaire score at end of treatment

    Week 8

Secondary Outcomes (2)

  • Parental feeding practices

    Baseline and Week 8

  • Child eating behaviors

    Baseline and Week 8

Study Arms (1)

PBP-B

EXPERIMENTAL

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

Behavioral: Parent-based prevention following bariatric surgery

Interventions

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.

PBP-B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

ObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra L Safer, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Shiri Sadeh-Sharvit, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • James Lock, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pre-post design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 29, 2020

Study Start

February 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations