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OpenTrials
Completed

NCT Number: NCT04247113

Parent-Based Intervention Following a Weight Loss Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The biological parent of a child between 1-10 years of age.
  • Has undergone a weight loss surgery.

Exclusion criteria

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

Treatment and study plan

Parent-based prevention following bariatric surgery

Behavioral

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.

Primary outcomes

  1. 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

  2. Acceptability of the intervention

    Time frame: Week 8

    Client Satisfaction Questionnaire score at end of treatment

Secondary outcomes

  1. Parental feeding practices

    Time frame: Baseline and Week 8

    Change scores of the Child Feeding Questionnaire from baseline to end of treatment

  2. Child eating behaviors

    Time frame: Baseline and Week 8

    Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Assessing the Feasibility and Acceptability of a Parent-Based Intervention to Reduce the Risk of Obesity in Children of Weight Loss Surgery Patients

Acronym: PBP-B

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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