Clinical trial NCT01889082: Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Official title: Recruiting and Retaining Young Adults in Behavioral Weight Loss Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
weight loss
young adults
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-06-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

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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.

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Primary outcomes:
measure: Adherence and Retention
timeFrame: 12 Weeks
Secondary outcomes:
measure: Weight Loss
timeFrame: 3 Months
Other outcomes:
measure: Satisfaction and Acceptability
timeFrame: 3 Months
measure: Waist Circumference
timeFrame: 3 Months
measure: Body Composition
timeFrame: 3 Months
measure: Blood Pressure
timeFrame: 3 Months
measure: Dietary Behaviors
timeFrame: 3 Months
measure: Physical Activity
timeFrame: 3 Months
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
Study officials:
affiliation: Virginia Commonwealthy University
name: Jessica G LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.