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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Behavioral Weight Loss Intervention for Young Adults

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01889082

HM14857

5K23DK083440-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups

Face to Face Behavioral Weight Loss

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral Weight Loss Intervention for Young Adults

Web Based Behavioral Weight Loss

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioral Weight Loss Intervention for Young Adults

Web Based Behavioral Weight Loss Plus Optional Group Sessions

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss Intervention for Young Adults