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CompletedNCT04254068PBPUpdated May 27, 2020

Parent-Based Prevention (PBP) for Parents With Eating Disorders

An interventional study of Parent-based prevention in Eating Disorders and Eating Behavior, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Jan 2014, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Eating Disorders
  • Eating Behavior

Keywords

  • Secondary prevention
  • Parent-based prevention
03

In context

Feeding and Eating Disorders

740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.

This study's enrollment of 24 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A biological parent of a child between 1-5 years of age.
  • A lifetime diagnosis of an eating disorder.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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.

    Behavioral: Parent-based prevention

  • 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.

Interventions

  • BehavioralParent-based prevention

    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.

    Also known as: PBP

06

What researchers measure

Primary outcomes

  1. Feasibility of recruiting parents with a lifetime diagnosis of an eating disorder: Number of eligible participants that agree to participate in the study

    Number of eligible participants that agree to participate in the study

    Time frame: Up to 48 months

  2. Acceptability of the intervention: Client Satisfaction Questionnaire score

    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.

    Time frame: Week 12

Secondary outcomes

  1. Parental feeding practices

    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.

    Time frame: Baseline and Week 12

  2. Child eating behaviors

    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.

    Time frame: Baseline and Week 12

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Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04254068
Lead sponsor
Stanford University
Responsible party
James Dale Lock (Professor of Psychiatry and Behavioral Sciences, Stanford University) — Principal investigator
First posted
Feb 5, 2020
Start date
Jan 24, 2014
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
May 27, 2020

Study contacts

Shiri Sadeh-Sharvit, PhD
principal investigator · s

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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