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Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment (SPARKRVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889082
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Weight Loss [ Time Frame: 3 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 21, 2013)
  • Satisfaction and Acceptability [ Time Frame: 3 Months ]
    We will assess satisfaction, perceived quality of the interventions, perceived relevance for young adults. Satisfaction will be measured on a likert scale. Acceptability will be measured by engagment.
  • Waist Circumference [ Time Frame: 3 Months ]
  • Body Composition [ Time Frame: 3 Months ]
  • Blood Pressure [ Time Frame: 3 Months ]
  • Dietary Behaviors [ Time Frame: 3 Months ]
  • Physical Activity [ Time Frame: 3 Months ]
Original Other Pre-specified Outcome Measures
 (submitted: June 27, 2013)
  • Satisfaction and Acceptability [ Time Frame: 3 Months ]
    We will assess satisfaction, perceived quality of the interventions, perceived relevance for young adults.
  • Waist Circumference [ Time Frame: 3 Months ]
  • Body Composition [ Time Frame: 3 Months ]
  • Blood Pressure [ Time Frame: 3 Months ]
  • Dietary Behaviors [ Time Frame: 3 Months ]
  • Physical Activity [ Time Frame: 3 Months ]
 
Descriptive Information
Brief Title  ICMJE Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Official Title  ICMJE Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Behavioral Weight Loss Intervention for Young Adults
Study Arms  ICMJE
  • Active Comparator: Face to Face Behavioral Weight Loss
    12-week treatment program consisting of weekly, in-person group meetings and brief, bi-weekly individual check-ins
    Intervention: Behavioral: Behavioral Weight Loss Intervention for Young Adults
  • Active Comparator: Web Based Behavioral Weight Loss
    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
    Intervention: Behavioral: Behavioral Weight Loss Intervention for Young Adults
  • Active Comparator: Web Based Behavioral Weight Loss Plus Optional Group Sessions
    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.
    Intervention: Behavioral: Behavioral Weight Loss Intervention for Young Adults
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
45
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Between 18-25 years of age. Body Mass Index (BMI) between 25 and 45 kg/m2. Men and women will be recruited. All race and ethnic groups will be recruited.

-

Exclusion Criteria:

  1. Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
  2. 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.
  3. 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).
  4. 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.
  5. Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
  6. Are currently participating in a weight loss program and/or taking weight loss medication.
  7. Lost > 5% of body weight during the past 6 months or history of bariatric surgery.
  8. Participation in any other research study that may interfere with this study.
  9. 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.
  10. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
  11. Failure to complete screening appointments.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889082
Other Study ID Numbers  ICMJE HM14857
5K23DK083440-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Jessica G LaRose, PhD Virginia Commonwealthy University
PRS Account Virginia Commonwealth University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP