MI for Weight Loss With Young Adults (Live Well RVA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01899625
First received: July 6, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Behavioral Weight Loss Intervention for Young Adults
Behavioral: Motivation Enhanced Behavioral Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Motivational Interviewing to Improve Weight Loss Outcomes With Young Adults

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Primary Aims Include:

    Primary Aim 1: To determine the feasibility of an MI-based approach to weight loss in young adults. Specifically, to demonstrate that we can: 1) recruit 18-25 year olds into the proposed program, 2) keep them engaged, as evidenced by achieving >80% attendance and >80% completion of tracking / reporting activities, and 3) retain them for assessments, as evidence by achieving >80% retention at 12 and 24 week visits.


  • Adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Primary Aim 2: To explore whether the MIBWL arm produces better adherence (see Aim 1, item 2), retention, autonomous motivation, and satisfaction, all of which may be related to better weight losses in the long-term.


Secondary Outcome Measures:
  • Weight Loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To explore whether the MIBWL arm is a viable approach to weight loss in this age group. Specifically, within group, we will examine mean weight change and proportion of participants achieving a clinically significant weight loss (>5%). Although not powered to detect differences, we will also explore differences in mean weight change between the MIBWL and BBWL groups.


Estimated Enrollment: 45
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Motivation Enhanced Behavioral Weight Loss
12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals.
Behavioral: Motivation Enhanced Behavioral Weight Loss
12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals.
Active Comparator: Brief Behavioral Weight Loss
12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week.
Behavioral: Behavioral Weight Loss Intervention for Young Adults
12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week.

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, 3, and 6 months, followed by exit interviews to help refine the protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899625

Contacts
Contact: Megan M Blumenthal, B.S. 804-827-2250 blumenthalmm@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Jessca G LaRose, PhD    804-628-7521    jlarose@vcu.edu   
Principal Investigator: Jessica G LaRose, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Jessica G LaRose, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01899625     History of Changes
Other Study ID Numbers: HM14613, R03DK095959
Study First Received: July 6, 2013
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Virginia Commonwealth University:
Obesity
weight loss
young adults

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 31, 2014