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

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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

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral Weight Loss Intervention for Young Adults Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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
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.
Behavioral: Behavioral Weight Loss Intervention for Young Adults



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: 3 Months ]

Other Outcome Measures:
  1. 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.

  2. Waist Circumference [ Time Frame: 3 Months ]
  3. Body Composition [ Time Frame: 3 Months ]
  4. Blood Pressure [ Time Frame: 3 Months ]
  5. Dietary Behaviors [ Time Frame: 3 Months ]
  6. Physical Activity [ Time Frame: 3 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889082


Locations
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United States, Virginia
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jessica G LaRose, PhD Virginia Commonwealthy University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01889082    
Other Study ID Numbers: HM14857
5K23DK083440-06 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Virginia Commonwealth University:
Obesity
weight loss
young adults
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes