Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
SPARKRVA
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 18, 2014
December 1, 2014
1.7 years
March 11, 2013
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence and Retention
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.
12 Weeks
Secondary Outcomes (1)
Weight Loss
3 Months
Other Outcomes (6)
Satisfaction and Acceptability
3 Months
Waist Circumference
3 Months
Body Composition
3 Months
- +3 more other outcomes
Study Arms (3)
Face to Face Behavioral Weight Loss
ACTIVE COMPARATOR12-week treatment program consisting of weekly, in-person group meetings and brief, bi-weekly individual check-ins
Web Based Behavioral Weight Loss
ACTIVE COMPARATOR12-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 COMPARATOR12-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.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 28810394DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica G LaRose, PhD
Virginia Commonwealthy University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
June 28, 2013
Study Start
January 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 18, 2014
Record last verified: 2014-12