Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01889082
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence and Retention	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

Name	Time	Method
Weight Loss	3 Months

Trial Locations

Locations (1)

Virginia Commonwealth University School of Medicine; 🇺🇸 Richmond, Virginia, United States