ObesityPBP-BNCT04247113
Parent-Based Intervention Following a Weight Loss Surgery
A study testing Parent-based prevention following bariatric surgery in people with Obesity and Obesity, Childhood, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Childhood
- What is being tested?
- Parent-based prevention following bariatric surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Dec 2018
- 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
- The biological parent of a child between 1-10 years of age.
- Has undergone a weight loss surgery.
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: Assessing the Feasibility and Acceptability of a Parent-Based Intervention to Reduce the Risk of Obesity in Children of Weight Loss Surgery Patients
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.
Read the detailed description
Morbid obesity is both highly heritable and affected by environmental factors. The child of a parent undergoing a weight-loss surgery (PWLS) is at especially high risk of obesity. The most effective approach to reducing the risk of childhood obesity is a parent-based program. However, adherence remains a challenge, largely due to lack of tailored interventions. Typical interventions are not individualized to target the unique characteristics of the family nor timed to be delivered when the family is geared for change. Parent-Based Prevention following a bariatric surgery (PBP-B) is a novel targeted intervention that focuses on parental behaviors important for developing healthy eating and lifestyle behaviors in young children. PBP-B personalizes treatment goals through a focused parent-based approach that includes a family meal. Additionally, PBP-B is timed to capitalize on the Halo Effect period, in which the BMIs of the family members of the person undergoing weight loss surgery reduce spontaneously, yet only temporarily.
This study will investigate whether PBP-B is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of obesity (e.g., parental feeding practices, child eating behaviors, child physical activity levels, and child sleep hours). Ten adults who had weight loss surgery and are the parents of one or more children aged 1-10 will receive PBP-B (with their partners, unless they are single parents). This study will collect important pilot data that will inform the design of future adequately powered studies to test ways to reduce the likelihood of adult obesity in children of a parent who had weight loss surgery.
- Conditions
- Obesity, Obesity, Childhood
- Being tested
- Parent-based prevention following bariatric surgery
- Keywords
- bariatric surgery, Parent-based prevention
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-based prevention following bariatric surgeryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Parent-based prevention following bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting parents who have undergone a bariatric surgery
Number of eligible participants that agree to participate in the study
Measured: Up to 18 months
Acceptability of the intervention
Client Satisfaction Questionnaire score at end of treatment
Measured: Week 8
Secondary outcomes (2)
Parental feeding practices
Change scores of the Child Feeding Questionnaire from baseline to end of treatment
Measured: Baseline and Week 8
Child eating behaviors
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Feb 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post design
- Masking
- None (open label)
- Enrolment
- 10 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
- Debra L Safer, MD, Principal investigator, Stanford UniversityShiri Sadeh-Sharvit, PhD, Principal investigator, Stanford UniversityJames Lock, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247113
- Sponsor's protocol ID
- 36281
- Acronym
- PBP-B
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 29 Jan 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 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Acceptability of a Parent-Based Intervention to Reduce the Risk of Obesity in Children of Weight Loss Surgery Patients
- ClinicalTrials.gov ID
- NCT04247113
- Acronym / sponsor ID
- PBP-B / 36281
- Conditions
- Obesity, Obesity, Childhood
- Keywords
- bariatric surgery, Parent-based prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Jan 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.
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.
Detailed description
Morbid obesity is both highly heritable and affected by environmental factors. The child of a parent undergoing a weight-loss surgery (PWLS) is at especially high risk of obesity. The most effective approach to reducing the risk of childhood obesity is a parent-based program. However, adherence remains a challenge, largely due to lack of tailored interventions. Typical interventions are not individualized to target the unique characteristics of the family nor timed to be delivered when the family is geared for change. Parent-Based Prevention following a bariatric surgery (PBP-B) is a novel targeted intervention that focuses on parental behaviors important for developing healthy eating and lifestyle behaviors in young children. PBP-B personalizes treatment goals through a focused parent-based approach that includes a family meal. Additionally, PBP-B is timed to capitalize on the Halo Effect period, in which the BMIs of the family members of the person undergoing weight loss surgery reduce spontaneously, yet only temporarily.
This study will investigate whether PBP-B is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of obesity (e.g., parental feeding practices, child eating behaviors, child physical activity levels, and child sleep hours). Ten adults who had weight loss surgery and are the parents of one or more children aged 1-10 will receive PBP-B (with their partners, unless they are single parents). This study will collect important pilot data that will inform the design of future adequately powered studies to test ways to reduce the likelihood of adult obesity in children of a parent who had weight loss surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post design
| Arm | Type | Receives |
|---|---|---|
| PBP-B | Experimental | Behavioral: Parent-based prevention following bariatric surgeryParent-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The biological parent of a child between 1-10 years of age.
- Has undergone a weight loss surgery.
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 prevention following bariatric surgeryPBP-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. | Behavioural | PBP-B |
Primary outcome
Feasibility of recruiting parents who have undergone a bariatric surgery
Time frame: Up to 18 months
Number of eligible participants that agree to participate in the study
Acceptability of the intervention
Time frame: Week 8
Client Satisfaction Questionnaire score at end of treatment
2 secondary outcomes
Parental feeding practices
Time frame: Baseline and Week 8
Child eating behaviors
Time frame: Baseline and Week 8
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 29 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Debra L Safer, MD principal investigator
Stanford University
Shiri Sadeh-Sharvit, PhD principal investigator
Stanford University
James Lock, MD, PhD principal investigator
Stanford University
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 following bariatric surgery in people with Obesity and Obesity, Childhood, 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 29 Jan 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 who have undergone a bariatric surgery (time frame: Up to 18 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 29 Jan 2020.