Internet Obesity Treatment Enhanced With Motivational Interviewing (iReach2)

This study has been completed.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
JHarvey-Berino, University of Vermont
ClinicalTrials.gov Identifier:
NCT01232699
First received: November 1, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Internet-based weight control programs have been shown effective in producing weight loss, but in-person delivery of behavioral weight control produces significantly greater weight loss than on-line delivery of the same program. Motivational Interviewing has been shown to increase weight loss when delivered as an adjunct to in-person weight loss programs but has not been examined in conjunction with web-based obesity treatment. Therefore, the overall goal of this project is to determine if the addition of on-line Motivational Interviewing to a web-based group behavioral obesity treatment program will augment weight loss outcomes.


Condition Intervention Phase
Obesity
Behavioral: Internet Obesity Treatment
Behavioral: Internet Obesity Treatment with MI
Behavioral: Contingent MI
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet Obesity Treatment Enhanced With Motivational Interviewing

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale.

  • Change in Body Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Body Weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: 0 ] [ Designated as safety issue: No ]
    Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale. Height will be taken at baseline using a wall-mounted stadiometer and BMI will be calculated as weight (kg)/height(m2)


Secondary Outcome Measures:
  • Adherence to Treatment Components [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Items will include attendance at chat group meetings and completion of online food diaries and exercise records.

  • Adherence to Treatment Components [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adherence to Treatment Components [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Motivation Measures [ Time Frame: 0 ] [ Designated as safety issue: No ]
    We will assess participant motivation for participating in a weight reduction program and adhering to the program.

  • Motivation Measures [ Time Frame: 6 ] [ Designated as safety issue: No ]
  • Motivation Measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Motivation Measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 495
Study Start Date: December 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Internet Obesity Treatment
Participants will attend weekly class sessions on line and track food and exercise in an on-line journal.
Behavioral: Internet Obesity Treatment
Participants will engage in self monitoring, will receive skills training to help cope with environmental triggers, and will receive nutrition advice.
Other Name: iREACH2
Experimental: Internet Obesity Treatment with MI
Participants will attend weekly classes on line, record food and exercise in an on-line journal, and will have no more than 6 individual motivational interviewing sessions.
Behavioral: Internet Obesity Treatment with MI
In addition to weekly group meetings, self-monitoring through recording calorie and fat intake daily as well as exercise, participants will meet one-on-one with an MI counselor on-line in order to augment an individual's motivation to change behavior.
Other Name: iREACH2
Experimental: Contingent MI
Intervention is the same as for the MI arm, however participants will only receive MI if meeting certain treatment participation conditions.
Behavioral: Contingent MI
Participants will attend weekly behavioral internet meetings. They may or may not receive Motivational Interviewing depending on their class attendance.
Other Name: iReach2

Detailed Description:

This randomized controlled trial is designed to determine whether weight losses in a group behavioral weight loss intervention conducted over the Internet are increased with the inclusion of individual, online MI sessions. All participants will receive the same online 6-month group-based behavioral weight loss program followed by 12 months of weight maintenance. Overweight and obese adults at two study sties (N=426) will be randomized to (1) Internet intervention; or 2) Internet intervention with individual MI sessions occurring at three month intervals on a fixed schedule (Internet+MI-Fixed). Assessments will be conducted every six months and will include measures of body weight and height, diet and exercise behaviors, Quality of Life, adherence measures (eg., attendance, compliance with self-monitoring), social influence components, motivation, treatment satisfaction, demographic data and descriptive information regarding use of website components. A third arm was added for the final 3 intervention cohorts. All participants received the program as described above with the addition of motivational interviewing contingent on participants' attendance in classes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be over 18
  • must have a BMI between 18 and 50
  • must live within 60 minutes driving distance of University of Arkansas, Little Rock, AR, or University of Vermont, Burlington, Vermont
  • must be able to walk for exercise

Exclusion Criteria:

  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: NCT01232699

Locations
United States, Arkansas
University of Arkansas for the Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Vermont
Behavioral Weight Management Program/Univ of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
University of Arkansas
Investigators
Principal Investigator: Jean R Harvey Berino, PhD. University of Vermont
Principal Investigator: Delia Smith-West, PhD. UAMS
  More Information

No publications provided

Responsible Party: JHarvey-Berino, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT01232699     History of Changes
Other Study ID Numbers: 10-124
Study First Received: November 1, 2010
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
obesity
weight loss
internet treatment
motivational interviewing

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

ClinicalTrials.gov processed this record on September 18, 2014