Health BehaviorNCT01699958
A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
A study testing Problem-solving intervention in people with Health Behavior, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Problem-solving intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of purging within the prior 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
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.
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Problem-solving intervention
- Keywords
- Problem solving therapy, Behavior change
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-solving interventionBehavioural
Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
| Study group | Role | What they receive |
|---|---|---|
| Problem-solving intervention | Experimental | 2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets. Receives: Behavioral: Problem-solving intervention |
| Control: Standard Care | No intervention | Control arm participants will receive standard of care from their primary care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Secondary outcomes (3)
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.
Measured: Change from baseline to 1-2 months
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.
Measured: Change from baseline to 1-2 months
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.
Measured: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Leslie Gee, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699958
- Sponsor's protocol ID
- StanfordIRB-20922
- Other IDs
- T32MH019938
- Status last verified
- Oct 2012
- First submitted
- 28 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01699958
- Acronym / sponsor ID
- StanfordIRB-20922
- Conditions
- Health Behavior
- Keywords
- Problem solving therapy, Behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem-solving intervention | Experimental | Behavioral: Problem-solving intervention2 individual sessions teaching problem-solving skills with the use of videos, handouts, and worksheets. |
| Control: Standard Care | No intervention | –Control arm participants will receive standard of care from their primary care provider. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- History of purging within the prior 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-solving interventionParticipants will receive 2 individual sessions teaching and reviewing problem-solving skills. | Behavioural | Problem-solving intervention |
Primary outcome
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
3 secondary outcomes
Change in problem-solving skills
Time frame: Change from baseline to 1-2 months
Change in confidence to maintain or improve healthy eating habits
Time frame: Change from baseline to 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Gee, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-solving intervention in people with Health Behavior, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.