Clinical trial NCT01899625: Motivational Interviewing for Weight Loss With Young Adults
Official title: Using Motivational Interviewing to Improve Weight Loss Outcomes With Young Adults
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: 2013-07-15
Enrollment: 51
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: This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.

Detailed description: This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Participants will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. Session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.

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.

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. -

Primary outcomes:
measure: Feasibility
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight Loss
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jessica G LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References: