Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment

NCT ID: NCT01889082

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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

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Obesity

Keywords

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Obesity weight loss young adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Face to Face Behavioral Weight Loss

12-week treatment program consisting of weekly, in-person group meetings and brief, bi-weekly individual check-ins

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss Intervention for Young Adults

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss Intervention for Young Adults

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss Intervention for Young Adults

Intervention Type BEHAVIORAL

Interventions

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Behavioral Weight Loss Intervention for Young Adults

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

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.

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica G LaRose, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealthy University

Locations

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Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28810394 (View on PubMed)

Other Identifiers

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5K23DK083440-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM14857

Identifier Type: -

Identifier Source: org_study_id