Motivational Interviewing for Weight Loss With Young Adults (LiveWellRVA)

Using Motivational Interviewing to Improve Weight Loss Outcomes With Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Motivation Enhanced BWL; Behavioral: Brief Behavioral Weight Loss (BWL)

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Motivation Enhanced BWL; 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 BWL; 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 (BWL); 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: Brief Behavioral Weight Loss (BWL); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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.	12 weeks
Adherence	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	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.	12 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jessica G LaRose, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 6, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; young adults; weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: HM14613; R03DK095959 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO