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Internet Obesity Treatment Enhanced With Motivational Interviewing

This study is ongoing, but not recruiting participants.
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: September 17, 2012
Last verified: September 2012
History of Changes

November 1, 2010
September 17, 2012
December 2010
September 2015   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01232699 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Internet Obesity Treatment Enhanced With Motivational Interviewing
Internet Obesity Treatment Enhanced With Motivational Interviewing

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.

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.
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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
  • 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
  • Active Comparator: Internet Obesity Treatment
    Participants will attend weekly class sessions on line and track food and exercise in an on-line journal.
    Intervention: Behavioral: Internet Obesity Treatment
  • 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.
    Intervention: Behavioral: Internet Obesity Treatment with MI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
426
December 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01232699
10-124
Yes
JHarvey-Berino, University of Vermont
University of Vermont
University of Arkansas
Principal Investigator: Jean R Harvey Berino, PhD. University of Vermont
Principal Investigator: Delia Smith-West, PhD. UAMS
University of Vermont
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP