- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254068
Parent-Based Prevention (PBP) for Parents With Eating Disorders (PBP)
May 25, 2020 updated by: James Dale Lock, Stanford University
Preventing Feeding and Eating Disorders in Children of Parents With Eating Disorders: A Randomized Controlled Trial
Parents with eating disorders exhibit greater concerns and dilemmas about developing healthy habits in their children.
Studies indicate that the offspring of parents with eating disorders have more developmental and interpersonal difficulties.
Consequently, these parents should receive personalized care to enhance their parental capacity and support them in their decision making process.
The Parent-Based Prevention of Eating Disorders (PBP) is a promising intervention that may help improve feeding and eating practices and children outcomes, by engaging both parents in a short-term program.
This study aims to empirically evaluate the feasibility and acceptability of PBP over a wait-list control group (i.e., treatment-as-usual) in a Randomized Case Series Trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A parental history of an eating disorder is linked with greater risk of eating and socio-emotional problems in the offspring, and more stressful parent-child interactions.
Further, parenting concerns often exacerbate existing eating disorder symptoms in parents.
Parent-Based Prevention (PBP-B) is a focused intervention aimed to support parents with eating disorders and their partners in developing healthy eating and lifestyle behaviors in their children.
The program also focuses on reducing mealtime conflict and improving couple communication.
This study tests the feasibility, acceptability and preliminary outcomes of the Parent-Based Prevention (PBP) program for these parents and their partners.
Parents with any lifetime eating disorder diagnosis who have at least one child 1-5 years old will be randomized to receive PBP immediately or following a 16-week waitlist period.
This study will investigate whether PBP is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of eating and weight disorders (e.g., parental cognition associated with feeding practices and child eating behaviors and socio-emotional symptoms).
The study will collect important case series data that will inform the design of larger, adequately powered studies to test ways to reduce the likelihood of eating and weight difficulties in the offspring of parents with eating disorders.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A biological parent of a child between 1-5 years of age.
- A lifetime diagnosis of an eating disorder.
Exclusion Criteria:
* Current medical condition necessitating more intensive care to manage symptoms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Parent based prevention
Parent-Based Prevention (PBP; Sadeh-Sharvit & Lock, 2018) is a manualized preventive intervention, focused on increasing parental awareness and competence to facilitate healthy eating habits, body image, and self-regulation in children whose parent has an eating disorder history.
PBP is comprised of three phases that focus on unique goals.
The strategies in each session include psycho-education, behavioral experiment planning, and skill practicing to augment parents' insight into how the context of the parental cognitions and behaviors may impact child outcomes, with the goal of creating a longstanding effect.
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Parent-based prevention is a 12 session program for parents with eating disorders and their partners.
Most sessions occur on a weekly basis, most of the sessions involve both partners.
Other Names:
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NO_INTERVENTION: Usual care
Families randomized to usual care will be permitted to utilize any medical, psychological, or nutritional services they desire for the waitlist period of 16 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruiting parents with a lifetime diagnosis of an eating disorder: Number of eligible participants that agree to participate in the study
Time Frame: Up to 48 months
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Number of eligible participants that agree to participate in the study
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Up to 48 months
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Acceptability of the intervention: Client Satisfaction Questionnaire score
Time Frame: Week 12
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Mean Client Satisfaction Questionnaire score at end of treatment.
Scores range on a Likert-like scale of 1-5, with higher scores indicative of greater satisfaction.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental feeding practices
Time Frame: Baseline and Week 12
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Change scores of the Child Feeding Questionnaire from baseline to end of treatment.
Scores range on a Likert-like scale of 1-5, with higher scores indicative of the parent endorsing more frequent behaviors on the dimension measured.
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Baseline and Week 12
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Child eating behaviors
Time Frame: Baseline and Week 12
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Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment.
Scores range on a Likert-like scale of 1-4, with higher scores indicative of greater endorsement of the behavior measured.
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Baseline and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shiri Sadeh-Sharvit, PhD, S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 24, 2014
Primary Completion (ACTUAL)
December 31, 2017
Study Completion (ACTUAL)
December 31, 2017
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (ACTUAL)
February 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 25, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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