Internet Obesity Treatment Enhanced With Motivational Interviewing (iReach2)

December 20, 2018 updated by: Jean R. Harvey, PhD, RD, University of Vermont
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

495

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for the Medical Sciences
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Behavioral Weight Management Program/Univ of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • iReach2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: 6 months
Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale.
6 months
Change in Body Weight
Time Frame: 12 months
12 months
Change in Body Weight
Time Frame: 18 months
18 months
Change in body weight
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

Outcome Measure
Measure Description
Time Frame
Adherence to Treatment Components
Time Frame: 6 months
Items will include attendance at chat group meetings and completion of online food diaries and exercise records.
6 months
Adherence to Treatment Components
Time Frame: 12 months
12 months
Adherence to Treatment Components
Time Frame: 18 months
18 months
Motivation Measures
We will assess participant motivation for participating in a weight reduction program and adhering to the program.
Motivation Measures
Time Frame: 6
6
Motivation Measures
Time Frame: 12 months
12 months
Motivation Measures
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

University of Arkansas

Investigators

  • Principal Investigator: Jean R Harvey Berino, PhD., University of Vermont
  • Principal Investigator: Delia Smith-West, PhD., UAMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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