A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
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|ClinicalTrials.gov Identifier: NCT01699958|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior||Behavioral: Problem-solving intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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.
- 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
- 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.
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
|United States, California|
|Stanford University School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Leslie Gee, MD||Stanford University|