- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04247113
Parent-Based Intervention Following a Weight Loss Surgery (PBP-B)
Assessing the Feasibility and Acceptability of a Parent-Based Intervention to Reduce the Risk of Obesity in Children of Weight Loss Surgery Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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California
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Stanford, California, Förenta staterna, 94305
- Stanford University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: PBP-B
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
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of recruiting parents who have undergone a bariatric surgery
Tidsram: Up to 18 months
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Number of eligible participants that agree to participate in the study
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Up to 18 months
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Acceptability of the intervention
Tidsram: Week 8
|
Client Satisfaction Questionnaire score at end of treatment
|
Week 8
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Parental feeding practices
Tidsram: Baseline and Week 8
|
Change scores of the Child Feeding Questionnaire from baseline to end of treatment
|
Baseline and Week 8
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Child eating behaviors
Tidsram: Baseline and Week 8
|
Change scores of the Children's Eating Behavior Questionnaire from baseline to end of treatment
|
Baseline and Week 8
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Debra L Safer, MD, Stanford University
- Huvudutredare: Shiri Sadeh-Sharvit, PhD, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 36281
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på Fetma
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SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark