An interventional study of Internet Obesity Treatment and Internet Obesity Treatment with MI in Obesity, sponsored by University of Vermont. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
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. 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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 495 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Exclusion Criteria:
Participants will attend weekly class sessions on line and track food and exercise in an on-line journal.
Behavioral: Internet Obesity Treatment
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
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 engage in self monitoring, will receive skills training to help cope with environmental triggers, and will receive nutrition advice.
Also known as: iREACH2
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.
Also known as: iREACH2
Participants will attend weekly behavioral internet meetings. They may or may not receive Motivational Interviewing depending on their class attendance.
Also known as: iReach2
Change in Body Weight
Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale.
Time frame: 6 months
Change in Body Weight
Time frame: 12 months
Change in Body Weight
Time frame: 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)
Time frame: 0
Adherence to Treatment Components
Items will include attendance at chat group meetings and completion of online food diaries and exercise records.
Time frame: 6 months
Adherence to Treatment Components
Time frame: 12 months
Adherence to Treatment Components
Time frame: 18 months
Motivation Measures
We will assess participant motivation for participating in a weight reduction program and adhering to the program.
Time frame: 0
Motivation Measures
Time frame: 6
Motivation Measures
Time frame: 12 months
Motivation Measures
Time frame: 18 months
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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University of Vermont