Motivational Interviewing for Weight Loss With Young Adults

NCT01899625 | Completed

• 2 other identifiers: HM14613R03DK095959
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; weight loss; young adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Weight Loss

  12 weeks

Study Arms (2)

Motivation Enhanced BWL

ACTIVE COMPARATOR

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

Brief Behavioral Weight Loss (BWL)

ACTIVE COMPARATOR

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)

Interventions

Brief Behavioral Weight Loss (BWL) BEHAVIORAL

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.

Brief Behavioral Weight Loss (BWL)

Motivation Enhanced BWL BEHAVIORAL

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.

Motivation Enhanced BWL

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
• 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.
• 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).
• 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.
• Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
• Are currently participating in a weight loss program and/or taking weight loss medication.
• Lost \> 5% of body weight during the past 6 months or history of bariatric surgery.
• Participation in any other research study that may interfere with this study.
• 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.
• Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
• Failure to complete screening appointments. -

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jessica G LaRose, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2013
• First Posted: July 15, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)