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Completed

NCT Number: NCT01699958

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.

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Key information

Conditions

Health Behavior Behavior

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem-solving intervention

Behavioral

Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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