SmokingHFDCNCT01969760
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
A study testing Healthy Families DC Program in people with Smoking and Overweight, run by Cassandra Stanton, PhD at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Overweight, Obesity
- What is being tested?
- Healthy Families DC Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to May 2014
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students aged 12-16 years
- Attending regular education classes at three urban DC public middle schools. -Students must currently reside with at least one parent or guardian who wishes to also participate in this study.
- Students and at least one guardian must be fluent in English
Who cannot join
- Adolescents, who are outside the study age range
- Patients/parents unable to speak/read English
- Are wards of the state
- Not attending regular education classes at the public middle schools -Furthermore, adolescents and guardians not assenting/consenting to be in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
The purpose of this study is to examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families.
Read the detailed description
Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity, high risk behaviors such as tobacco and substance use and resulting cardiovascular and chronic disease. In this study we modified a tobacco and substance use risk prevention program to develop a tailored intervention (Healthy Families DC) that also included promotion of physical activity (PA) for DC middle-school students referred by school staff as over-weight and at risk for problem behaviors. The program included an initial family assessment, a family feedback session with family PA goal setting and 6 phone/text based booster sessions. A pilot study with 18 families, comprised of at least one caregiver and target child, was conducted to examine feasibility, acceptability, and trends in preliminary outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco use), health goal setting, and changes in family functioning (e.g., youth positive behaviors, parenting).
- Conditions
- Smoking, Overweight, Obesity
- Being tested
- Healthy Families DC Program
- Medical subject headings
- Smoking, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Families DC ProgramBehavioural
A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control | No intervention | Wait-list control. No intervention delivered until post follow-up assessment. Upon completion of the follow-up, the family was offered the full intervention. |
| Healthy Families DC Program | Experimental | Healthy Families DC Program Receives: Behavioral: Healthy Families DC Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
Measured: 8-weeks
Secondary outcomes (1)
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cassandra Stanton, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cassandra Stanton, PhD, Georgetown University
- Investigators
- Cassandra A Stanton, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969760
- Sponsor's protocol ID
- 2013-0614
- Acronym
- HFDC
- Status last verified
- Jan 2015
- First submitted
- 22 Oct 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
- ClinicalTrials.gov ID
- NCT01969760
- Acronym / sponsor ID
- HFDC / 2013-0614
- Conditions
- Smoking, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cassandra Stanton, PhDUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Oct 2013 (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 examine the feasibility and acceptability of a family-based program to improve physical activity and tobacco outcomes in a small pilot of middle school students and their families.
Detailed description
Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity, high risk behaviors such as tobacco and substance use and resulting cardiovascular and chronic disease. In this study we modified a tobacco and substance use risk prevention program to develop a tailored intervention (Healthy Families DC) that also included promotion of physical activity (PA) for DC middle-school students referred by school staff as over-weight and at risk for problem behaviors. The program included an initial family assessment, a family feedback session with family PA goal setting and 6 phone/text based booster sessions. A pilot study with 18 families, comprised of at least one caregiver and target child, was conducted to examine feasibility, acceptability, and trends in preliminary outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco use), health goal setting, and changes in family functioning (e.g., youth positive behaviors, parenting).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list control | No intervention | –Wait-list control. No intervention delivered until post follow-up assessment. Upon completion of the follow-up, the family was offered the full intervention. |
| Healthy Families DC Program | Experimental | Behavioral: Healthy Families DC ProgramHealthy Families DC Program |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students aged 12-16 years
- Attending regular education classes at three urban DC public middle schools. -Students must currently reside with at least one parent or guardian who wishes to also participate in this study.
- Students and at least one guardian must be fluent in English
Key exclusion criteria (4 listed)
- Adolescents, who are outside the study age range
- Patients/parents unable to speak/read English
- Are wards of the state
- Not attending regular education classes at the public middle schools -Furthermore, adolescents and guardians not assenting/consenting to be in the study will be excluded.
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 |
|---|---|---|
| Healthy Families DC ProgramA tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity | Behavioural | Healthy Families DC Program |
Primary outcome
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline
Time frame: 8-weeks
1 secondary outcome
Smoking Susceptibility Scale changes from baseline to 8-weeks post-baseline
Time frame: 8 weeks
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 28 Jan 2015.
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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.
Cassandra A Stanton, PhD principal investigator
Georgetown 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 Healthy Families DC Program in people with Smoking and Overweight, run by Cassandra Stanton, PhD 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 4 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 28 Jan 2015. 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?
Actigraphy-based changes in physical activity from baseline to 8-weeks post-baseline (time frame: 8-weeks). 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 28 Jan 2015.