Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment

Obesity Clinical Trial

— SPARKRVA  

Official title:

Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889082
• Other study ID #: HM14857
• Secondary ID: 5K23DK083440-06
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: December 16, 2014
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Behavioral Weight Loss Intervention for Young Adults

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Medicine	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction and Acceptability	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.	3 Months	No
Other	Waist Circumference		3 Months	No
Other	Body Composition		3 Months	No
Other	Blood Pressure		3 Months	No
Other	Dietary Behaviors		3 Months	No
Other	Physical Activity		3 Months	No
Primary	Adherence and Retention	Primary Aims Include: 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.; 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.; To determine whether engagement and retention is improved in the web-based BWL program by the addition of optional in-person sessions.	12 Weeks	No
Secondary	Weight Loss		3 Months	No