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A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699958
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stanford University
  Purpose
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.

Condition Intervention
Health Behavior Behavioral: Problem-solving intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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:

    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


Secondary Outcome Measures:
  • 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 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.

  • 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.


Enrollment: 50
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Problem-solving intervention
2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets.
Behavioral: Problem-solving intervention
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699958


Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Leslie Gee, MD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01699958     History of Changes
Other Study ID Numbers: StanfordIRB-20922
T32MH019938 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2012
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Stanford University:
Problem solving therapy
Behavior change