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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04254068
Other study ID # 29032
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2014
Est. completion date December 31, 2017

Study information

Verified date May 2020
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Parent-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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 48 months
Primary 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. Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
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