Eating DisordersPBPNCT04254068
Parent-Based Prevention (PBP) for Parents With Eating Disorders
A study testing Parent-based prevention in people with Eating Disorders and Eating Behavior, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Eating Behavior
- What is being tested?
- Parent-based prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A biological parent of a child between 1-5 years of age.
- A lifetime diagnosis of an eating disorder.
Who cannot join
- Current medical condition necessitating more intensive care to manage symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Eating Disorders, Eating Behavior
- Being tested
- Parent-based prevention
- Keywords
- Secondary prevention, Parent-based prevention
- Medical subject headings
- Feeding and Eating Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-based preventionBehavioural
Also called PBP
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent based prevention | Experimental | 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. Receives: Behavioral: Parent-based prevention |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 48 months
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.
Measured: Week 12
Secondary outcomes (2)
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start24 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized case series trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
- Investigators
- Shiri Sadeh-Sharvit, PhD, Principal investigator, s
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254068
- Sponsor's protocol ID
- 29032
- Acronym
- PBP
- Status last verified
- May 2020
- First submitted
- 31 Jan 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Feeding and Eating Disorders in Children of Parents With Eating Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04254068
- Acronym / sponsor ID
- PBP / 29032
- Conditions
- Eating Disorders, Eating Behavior
- Keywords
- Secondary prevention, Parent-based prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized case series trial
| Arm | Type | Receives |
|---|---|---|
| Parent based prevention | Experimental | Behavioral: Parent-based preventionParent-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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A biological parent of a child between 1-5 years of age.
- A lifetime diagnosis of an eating disorder.
Key exclusion criteria (1 listed)
- Current medical condition necessitating more intensive care to manage symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-based preventionAlso: PBPParent-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. | Behavioural | Parent based prevention |
Primary outcome
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
Number of eligible participants that agree to participate in the study
Acceptability of the intervention: Client Satisfaction Questionnaire score
Time frame: Week 12
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.
2 secondary outcomes
Parental feeding practices
Time frame: Baseline and Week 12
Child eating behaviors
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
Related trials for Eating Disorders
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiri Sadeh-Sharvit, PhD principal investigator
s
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-based prevention in people with Eating Disorders and Eating Behavior, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.