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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01699958
First received: September 28, 2012
Last updated: October 1, 2012
Last verified: October 2012
  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: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699958

Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Leslie Gee, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01699958     History of Changes
Other Study ID Numbers: StanfordIRB-20922, T32MH019938
Study First Received: September 28, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Problem solving therapy
Behavior change

ClinicalTrials.gov processed this record on April 17, 2014