ObesitySPARKNCT01578512
SPARK a Healthy and Fit Lifestyle
A study testing Face-to-Face, Web-based and Single session in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obesity
- What is being tested?
- Face-to-Face, Web-based and Single session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-25 years old
- body mass index 25-45
- willing to be randomly assigned to any of the 3 arms
- available during the time frame of the study
- willing to complete assessment visits at 0, 2, 4 and 6 months
Who cannot join
- Age or BMI outside of eligible range
- Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
- Pregnant or nursing within 6 months
- recent weight loss >10% of body weight
- History of eating disorder
- Substance abuse or dependence
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center, the Miriam Hospital
Providence, Rhode Island, 02903
Jessica LaRose, PhD, 401-793-8283
Jessica G LaRose, PhD
About this study
The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.
- Conditions
- Obesity
- Being tested
- Face-to-Face, Web-based, Single session
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-FaceBehavioural
Face-to-Face behavioral weight loss
Web-basedBehavioural
Web-based behavioral weight loss
Single sessionBehavioural
The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face | Experimental | 8 sessions of weekly group behavioral weight loss treatment Receives: Behavioral: Face-to-Face |
| Web-based | Experimental | Participants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress. Receives: Behavioral: Web-based |
| Single Session | Active comparator | Single session behavioral weight loss Receives: Behavioral: Single session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 2 months (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578512
- Sponsor's protocol ID
- DK083440
- Acronym
- SPARK
- Status last verified
- Mar 2012
- First submitted
- 12 Apr 2012
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARK a Healthy and Fit Lifestyle
- ClinicalTrials.gov ID
- NCT01578512
- Acronym / sponsor ID
- SPARK / DK083440
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 17 Apr 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 determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face | Experimental | Behavioral: Face-to-Face8 sessions of weekly group behavioral weight loss treatment |
| Web-based | Experimental | Behavioral: Web-basedParticipants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress. |
| Single Session | Active comparator | Behavioral: Single sessionSingle session behavioral weight loss |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-25 years old
- body mass index 25-45
- willing to be randomly assigned to any of the 3 arms
- available during the time frame of the study
- willing to complete assessment visits at 0, 2, 4 and 6 months
Key exclusion criteria (6 listed)
- Age or BMI outside of eligible range
- Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
- Pregnant or nursing within 6 months
- recent weight loss >10% of body weight
- History of eating disorder
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 |
|---|---|---|
| Face-to-FaceFace-to-Face behavioral weight loss | Behavioural | Face-to-Face |
| Web-basedWeb-based behavioral weight loss | Behavioural | Web-based |
| Single sessionThe core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session. | Behavioural | Single Session |
Primary outcome
Weight
Time frame: 2 months (post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face, Web-based and Single session in people with Obesity, run by The Miriam Hospital 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica LaRose, PhD (401-793-8283, jessica_gokee_larose@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 2 months (post-treatment)). 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 17 Apr 2012.