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Clinical Trials/NCT04247113
NCT04247113CompletedNot Applicable

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

Stanford University2 sites in 1 country10 target enrollmentStarted: February 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Feasibility of recruiting parents who have undergone a bariatric surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Parental feeding practices(Baseline and Week 8)
  • Child eating behaviors(Baseline and Week 8)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James Dale Lock

Professor of Psychiatry and Behavioral Sciences

Stanford University

Study Sites (2)

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