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

Health Behavior Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699958
• Other study ID #: StanfordIRB-20922
• Secondary ID: T32MH019938
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: October 1, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Problem-solving intervention
Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility to conduct a brief problem-solving intervention in a busy academic outpatient setting.	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	From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months	No
Secondary	Change in problem-solving skills	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	No
Secondary	Change in confidence to maintain or improve healthy eating habits	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	No
Secondary	Sufficient recruitment and retention rates	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	No