- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699958
A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
October 1, 2012 updated by: Stanford University
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will refine, evaluate the feasibility, and estimate the effect of a brief problem-solving intervention to promote healthy eating and activity habits in adolescents.
Intervention participants will receive 2 sessions of individual behavioral counseling on problem-solving skills utilizing educational videos, handouts, and worksheets.
Intervention participants will be asked to generate unique health goals and practice utilizing problem-solving skills to achieve these goals.Control participants will receive standard of care.
Outcomes will explore the ability to shorten the intervention, integrate the intervention into busy outpatient clinics, and estimate the effect of the intervention on confidence to maintain or improve healthy habits and to improve problem-solving skills.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 13-18 years old
- Able to read and speak English
- Patient of the Lucile Packard Children's Hospital teen clinic, weight clinic, or mobile teen van
Exclusion Criteria:
- History of purging within the prior 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Problem-solving intervention
2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets.
|
Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
|
No Intervention: Control: Standard Care
Control arm participants will receive standard of care from their primary care provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility to conduct a brief problem-solving intervention in a busy academic outpatient setting.
Time Frame: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
|
Feasibility will be measured in the following ways:
|
From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in problem-solving skills
Time Frame: Change from baseline to 1-2 months
|
Participants will complete survey questions modified from the Social Problem-Solving Inventory for Adolescents (SPSI-A) both pre-intervention and post-intervention.
These questions provide an assessment of problem-solving skills and are scored on a Likert scale of 1-5 with 5=more positive/constructive problem-solving skills.
Change in overall mean score from pre- to post- intervention will be compared within intervention and control groups and between groups.
Duration of time between pre- and post- intervention will average 1-2 months.
|
Change from baseline to 1-2 months
|
Change in confidence to maintain or improve healthy eating habits
Time Frame: Change from baseline to 1-2 months
|
Participants will complete pre- and post- intervention questions on confidence to maintain or improve healthy eating habits.
An example question: "How confident are you that you could change or maintain your eating patterns to limit soda to <1 can/day."
Questions will be scored on a Likert scale of 1-6 with 6=very confident.
Change in overall mean score from pre- to post- intervention will be compared within intervention and control groups and between groups.
Duration of time between pre- and post- intervention will average about 1-2 months.
|
Change from baseline to 1-2 months
|
Sufficient recruitment and retention rates
Time Frame: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
|
Detailed records of patients approached, consented, randomized, and completing the study will be maintained.
These records will be reviewed at the conclusion of the study to gauge patient interest in participating in a problem-solving intervention in the outpatient setting.
|
From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Leslie Gee, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
September 28, 2012
First Submitted That Met QC Criteria
October 1, 2012
First Posted (Estimate)
October 4, 2012
Study Record Updates
Last Update Posted (Estimate)
October 4, 2012
Last Update Submitted That Met QC Criteria
October 1, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- StanfordIRB-20922
- T32MH019938 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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