Clinical trial NCT04247113: Parent-Based Intervention Following a Weight Loss Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obesity, Childhood
Keywords: bariatric surgery
Parent-based prevention
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post design
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruiting parents who have undergone a bariatric surgery
timeFrame: Up to 18 months
measure: Acceptability of the intervention
timeFrame: Week 8
Secondary outcomes:
measure: Parental feeding practices
timeFrame: Baseline and Week 8
measure: Child eating behaviors
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Debra L Safer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Shiri Sadeh-Sharvit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: James Lock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: