ObesitySPARKRVANCT01889082
Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
A study testing Behavioral Weight Loss Intervention for Young Adults in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
A randomized pilot study will be conducted, the goal of which is to determine which format represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss Intervention for Young Adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
- Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
- Report a history of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
- Are currently participating in a weight loss program and/or taking weight loss medication.
Show all 12Show fewer
- Lost > 5% of body weight during the past 6 months or history of bariatric surgery.
- Participation in any other research study that may interfere with this study.
- Intend to move outside of the surrounding area within the time frame of the investigation or will be out of town / unavailable for three or more weeks during the initial intervention period.
- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
- Failure to complete screening appointments.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
About this study
A randomized pilot study will be conducted, the goal of which is to determine which format represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. Specifically, participants will be randomized to one of three arms; all arms will receive a 12-week behavioral weight loss intervention, including identical dietary, physical activity, and weight loss prescriptions.
Read the detailed description
A randomized pilot study will be conducted, the goal of which is to determine which format represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. Specifically, participants will be randomized to one of three arms; all arms will receive a 12-week behavioral weight loss intervention, including identical dietary, physical activity, and weight loss prescriptions. Behavioral goals / prescriptions will be the same, and basic content delivered will also be the same; only the format by which the intervention is delivered will differ among the treatment arms. A total of 45-55 participants, 18-25 years of age, with a BMI between 25 and 45 kg/m2 will be randomized to one of three groups: 1) Face-to-face brief behavioral weight loss (FBWL), 2) Web-based brief behavioral weight loss (WBWL), or 3) Web-based brief behavioral weight loss PLUS optional group sessions (WBWL Plus). Assessments will take place at 0 (baseline), 3 (post-treatment), and 6 months (follow-up).
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss Intervention for Young Adults
- Keywords
- Obesity, weight loss, young adults
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss Intervention for Young AdultsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Face to Face Behavioral Weight Loss | Active comparator | 12-week treatment program consisting of weekly, in-person group meetings and brief, bi-weekly individual check-ins Receives: Behavioral: Behavioral Weight Loss Intervention for Young Adults |
| Web Based Behavioral Weight Loss | Active comparator | 12-week treatment program consisting of an initial in-person group session (weight loss 101 and intro to website), followed by weekly web-based program and e-coaching Receives: Behavioral: Behavioral Weight Loss Intervention for Young Adults |
| Web Based Behavioral Weight Loss Plus Optional Group Sessions | Active comparator | 12-week treatment program consisting of an initial in-person group session (weight loss 101 and intro to website), followed by weekly web-based program and e-coaching. Participants in this arm will also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training). *New material / content is not provided in these optional sessions, rather they are meant to serve as a place to practice applying the core content from the lessons. Receives: Behavioral: Behavioral Weight Loss Intervention for Young Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence and Retention
Primary Aims Include:
- To determine whether it is feasible to engage and retain 18-25 year olds in a clinic-based, face-to-face BWL program, as evidenced by achieving >80% attendance at sessions and >80% retention at post-treatment assessment visits.
- To determine whether it is feasible to engage and retain 18-25 year-olds in a web-based BWL program, as evidenced by achieving >80% completion of reporting activities and >80% retention at post-treatment assessment visits.
- To determine whether engagement and retention is improved in the web-based BWL program by the addition of optional in-person sessions.
Measured: 12 Weeks
Secondary outcomes (1)
Weight Loss
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica G LaRose, PhD, Principal investigator, Virginia Commonwealthy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889082
- Sponsor's protocol ID
- HM14857
- Other IDs
- 5K23DK083440-06
- Acronym
- SPARKRVA
- Status last verified
- Dec 2014
- First submitted
- 11 Mar 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
LaRose JG, Tate DF, Lanoye A, Fava JL, Jelalian E, Blumenthal M, Caccavale LJ, Wing RR. Adapting evidence-based behavioral weight loss programs for emerging adults: A pilot randomized controlled trial. J Health Psychol. 2019 Jun;24(7):870-887. doi: 10.1177/1359105316688951. Epub 2017 Jan 29.
PubMed 28810394
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT01889082
- Acronym / sponsor ID
- SPARKRVA / HM14857
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jun 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.
A randomized pilot study will be conducted, the goal of which is to determine which format represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. Specifically, participants will be randomized to one of three arms; all arms will receive a 12-week behavioral weight loss intervention, including identical dietary, physical activity, and weight loss prescriptions.
Detailed description
A randomized pilot study will be conducted, the goal of which is to determine which format represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. Specifically, participants will be randomized to one of three arms; all arms will receive a 12-week behavioral weight loss intervention, including identical dietary, physical activity, and weight loss prescriptions. Behavioral goals / prescriptions will be the same, and basic content delivered will also be the same; only the format by which the intervention is delivered will differ among the treatment arms. A total of 45-55 participants, 18-25 years of age, with a BMI between 25 and 45 kg/m2 will be randomized to one of three groups: 1) Face-to-face brief behavioral weight loss (FBWL), 2) Web-based brief behavioral weight loss (WBWL), or 3) Web-based brief behavioral weight loss PLUS optional group sessions (WBWL Plus). Assessments will take place at 0 (baseline), 3 (post-treatment), and 6 months (follow-up).
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 Behavioral Weight Loss | Active comparator | Behavioral: Behavioral Weight Loss Intervention for Young Adults12-week treatment program consisting of weekly, in-person group meetings and brief, bi-weekly individual check-ins |
| Web Based Behavioral Weight Loss | Active comparator | Behavioral: Behavioral Weight Loss Intervention for Young Adults12-week treatment program consisting of an initial in-person group session (weight loss 101 and intro to website), followed by weekly web-based program and e-coaching |
| Web Based Behavioral Weight Loss Plus Optional Group Sessions | Active comparator | Behavioral: Behavioral Weight Loss Intervention for Young Adults12-week treatment program consisting of an initial in-person group session (weight loss 101 and intro to website), followed by weekly web-based program and e-coaching. Participants in this arm will also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training). *New material / content is not provided in these optional sessions, rather they are meant to serve as a place to practice applying the core content from the lessons. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
- Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
- Report a history of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 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 |
|---|---|---|
| Behavioral Weight Loss Intervention for Young Adults | Behavioural | Face to Face Behavioral Weight Loss, Web Based Behavioral Weight Loss, Web Based Behavioral Weight Loss Plus Optional Group Sessions |
Primary outcome
Adherence and Retention
Time frame: 12 Weeks
Primary Aims Include: 1. To determine whether it is feasible to engage and retain 18-25 year olds in a clinic-based, face-to-face BWL program, as evidenced by achieving >80% attendance at sessions and >80% retention at post-treatment assessment visits. 2. To determine whether it is feasible to engage and retain 18-25 year-olds in a web-based BWL program, as evidenced by achieving >80% completion of reporting activities and >80% retention at post-treatment assessment visits. 3. To determine whether engagement and retention is improved in the web-based BWL program by the addition of optional in-person sessions.
1 secondary outcome
Weight Loss
Time frame: 3 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 18 Dec 2014.
- Derived from this study: PubMed 28810394LaRose JG, Tate DF, Lanoye A, Fava JL, Jelalian E, Blumenthal M, Caccavale LJ, Wing RR. Adapting evidence-based behavioral weight loss programs for emerging adults: A pilot randomized controlled trial. J Health Psychol. 2019 Jun;24(7):870-887. doi: 10.1177/1359105316688951. Epub 2017 Jan 29.
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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.
Jessica G LaRose, PhD principal investigator
Virginia Commonwealthy 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 Behavioral Weight Loss Intervention for Young Adults in people with Obesity, run by Virginia Commonwealth 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 0 inclusion and 12 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 18 Dec 2014. 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?
Adherence and Retention (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889082, which also lists 1 linked publication.
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 18 Dec 2014.