<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699958</url>
  </required_header>
  <id_info>
    <org_study_id>StanfordIRB-20922</org_study_id>
    <secondary_id>T32MH019938</secondary_id>
    <nct_id>NCT01699958</nct_id>
  </id_info>
  <brief_title>A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents</brief_title>
  <official_title>A Pilot Study of the &quot;Healthy Living Study,&quot; a Randomized Controlled Trial of a Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect&#xD;
      of the &quot;healthy Living Study,&quot; a brief outpatient problem-solving intervention to promote&#xD;
      healthy eating and activity habits in adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will refine, evaluate the feasibility, and estimate the effect of a brief&#xD;
      problem-solving intervention to promote healthy eating and activity habits in adolescents.&#xD;
      Intervention participants will receive 2 sessions of individual behavioral counseling on&#xD;
      problem-solving skills utilizing educational videos, handouts, and worksheets. Intervention&#xD;
      participants will be asked to generate unique health goals and practice utilizing&#xD;
      problem-solving skills to achieve these goals.Control participants will receive standard of&#xD;
      care. Outcomes will explore the ability to shorten the intervention, integrate the&#xD;
      intervention into busy outpatient clinics, and estimate the effect of the intervention on&#xD;
      confidence to maintain or improve healthy habits and to improve problem-solving skills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility to conduct a brief problem-solving intervention in a busy academic outpatient setting.</measure>
    <time_frame>From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months</time_frame>
    <description>Feasibility will be measured in the following ways:&#xD;
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&#xD;
Minimal disruption of clinic flow measured through clinic provider and staff satisfaction surveys and qualitative comments during the course of the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in problem-solving skills</measure>
    <time_frame>Change from baseline to 1-2 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in confidence to maintain or improve healthy eating habits</measure>
    <time_frame>Change from baseline to 1-2 months</time_frame>
    <description>Participants will complete pre- and post- intervention questions on confidence to maintain or improve healthy eating habits. An example question: &quot;How confident are you that you could change or maintain your eating patterns to limit soda to &lt;1 can/day.&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sufficient recruitment and retention rates</measure>
    <time_frame>From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Problem-solving intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control arm participants will receive standard of care from their primary care provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-solving intervention</intervention_name>
    <description>Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.</description>
    <arm_group_label>Problem-solving intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-18 years old&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Patient of the Lucile Packard Children's Hospital teen clinic, weight clinic, or&#xD;
             mobile teen van&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of purging within the prior 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leslie Gee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Problem solving therapy</keyword>
  <keyword>Behavior change</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699958
org study id: StanfordIRB-20922
secondary id: T32MH019938
nct id: NCT01699958
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
description: Feasibility will be measured in the following ways:
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
Minimal disruption of clinic flow measured through clinic provider and staff satisfaction surveys and qualitative comments during the course of the intervention
measure: Change in problem-solving skills
time frame: Change from baseline to 1-2 months
description: 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.
measure: Change in confidence to maintain or improve healthy eating habits
time frame: Change from baseline to 1-2 months
description: 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.
measure: 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
description: 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.
arm group label: Problem-solving intervention
arm group type: Experimental
description: 2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets.
arm group label: Control: Standard Care
arm group type: No Intervention
description: Control arm participants will receive standard of care from their primary care provider.
intervention type: Behavioral
intervention name: Problem-solving intervention
description: Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
arm group label: Problem-solving intervention
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leslie Gee, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor