iReach2: Internet Obesity Treatment Enhanced With Motivational Interviewing

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT01232699

Collaborator

University of Arkansas (Other)

495

Enrollment

Locations

Arms

Duration (Months)

247.5

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Internet Obesity Treatment Behavioral: Internet Obesity Treatment with MI Behavioral: Contingent MI	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

495 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Internet Obesity Treatment Enhanced With Motivational Interviewing

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Body Weight [6 months]
Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale.
Change in Body Weight [12 months]
Change in Body Weight [18 months]
Change in body weight [0]
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 [6 months]
Items will include attendance at chat group meetings and completion of online food diaries and exercise records.
Adherence to Treatment Components [12 months]
Adherence to Treatment Components [18 months]
Motivation Measures [0]
We will assess participant motivation for participating in a weight reduction program and adhering to the program.
Motivation Measures [6]
Motivation Measures [12 months]
Motivation Measures [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for the Medical Sciences	Little Rock	Arkansas	United States	72205
2	Behavioral Weight Management Program/Univ of Vermont	Burlington	Vermont	United States	05405