A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
A Pilot Study of the "Healthy Living Study," a Randomized Controlled Trial of a Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents.
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect of the "healthy Living Study," a brief outpatient problem-solving intervention to promote healthy eating and activity habits in adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedOctober 4, 2012
October 1, 2012
8 months
September 28, 2012
October 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility to conduct a brief problem-solving intervention in a busy academic outpatient setting.
Feasibility will be measured in the following ways: 1. Refinement of the intervention by the end of the study to a reasonable length to compliment average patient clinic visits with a goal of 30 minutes or less 2. Minimal disruption of clinic flow measured through clinic provider and staff satisfaction surveys and qualitative comments during the course of the intervention
From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Secondary Outcomes (3)
Change in problem-solving skills
Change from baseline to 1-2 months
Change in confidence to maintain or improve healthy eating habits
Change from baseline to 1-2 months
Sufficient recruitment and retention rates
From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Study Arms (2)
Problem-solving intervention
EXPERIMENTAL2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets.
Control: Standard Care
NO INTERVENTIONControl arm participants will receive standard of care from their primary care provider.
Interventions
Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
Eligibility Criteria
You may qualify if:
- years old
- Able to read and speak English
- Patient of the Lucile Packard Children's Hospital teen clinic, weight clinic, or mobile teen van
You may not qualify if:
- History of purging within the prior 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Stanford University School of Medicine
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Gee, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 4, 2012
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10