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ObesityiReach2NCT01232699

Internet Obesity Treatment Enhanced With Motivational Interviewing

A study testing Internet Obesity Treatment, Internet Obesity Treatment with MI and Contingent MI in people with Obesity, run by University of Vermont at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Internet Obesity Treatment, Internet Obesity Treatment with MI and Contingent MI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
495 participants
Where
2 sitesUnited States
Study dates
Dec 2010to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Behavioral Weight Management Program/Univ of Vermont

    Burlington, Vermont, 05405

  • University of Arkansas for the Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
Internet Obesity Treatment, Internet Obesity Treatment with MI, Contingent MI
Keywords
obesity, weight loss, internet treatment, motivational interviewing
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet Obesity TreatmentBehavioural

    Also called iREACH2

    Participants will engage in self monitoring, will receive skills training to help cope with environmental triggers, and will receive nutrition advice.

  • Internet Obesity Treatment with MIBehavioural

    Also called 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.

  • Contingent MIBehavioural

    Also called iReach2

    Participants will attend weekly behavioral internet meetings. They may or may not receive Motivational Interviewing depending on their class attendance.

Study groups in NCT01232699
Study groupRoleWhat they receive
Internet Obesity TreatmentActive comparatorParticipants will attend weekly class sessions on line and track food and exercise in an on-line journal.
Receives: Behavioral: Internet Obesity Treatment
Internet Obesity Treatment with MIExperimentalParticipants 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.
Receives: Behavioral: Internet Obesity Treatment with MI
Contingent MIExperimentalIntervention is the same as for the MI arm, however participants will only receive MI if meeting certain treatment participation conditions.
Receives: Behavioral: Contingent MI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Weight

    Weights will be taken in street clothes without shoes using a hospital quality digital floor model scale.

    Measured: 6 months

  2. Change in Body Weight

    Measured: 12 months

  3. Change in Body Weight

    Measured: 18 months

  4. 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)

    Measured: 0

Secondary outcomes (7)

  1. Adherence to Treatment Components

    Items will include attendance at chat group meetings and completion of online food diaries and exercise records.

    Measured: 6 months

  2. Adherence to Treatment Components

    Measured: 12 months

  3. Adherence to Treatment Components

    Measured: 18 months

  4. Motivation Measures

    We will assess participant motivation for participating in a weight reduction program and adhering to the program.

    Measured: 0

  5. Motivation Measures

    Measured: 6

  6. Motivation Measures

    Measured: 12 months

  7. Motivation Measures

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232699
Sponsor's protocol ID
10-124
Acronym
iReach2
Status last verified
Dec 2018
First submitted
1 Nov 2010
Last updated
24 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Harvey J, Krukowski R, Priest J, West D. Log Often, Lose More: Electronic Dietary Self-Monitoring for Weight Loss. Obesity (Silver Spring). 2019 Mar;27(3):380-384. doi: 10.1002/oby.22382.

    PubMed 30801989

  • West DS, Harvey JR, Krukowski RA, Prewitt TE, Priest J, Ashikaga T. Do individual, online motivational interviewing chat sessions enhance weight loss in a group-based, online weight control program? Obesity (Silver Spring). 2016 Nov;24(11):2334-2340. doi: 10.1002/oby.21645. Epub 2016 Sep 12.

    PubMed 27616628

  • Krukowski RA, DiLillo V, Ingle K, Harvey JR, West DS. Design and Methods of a Synchronous Online Motivational Interviewing Intervention for Weight Management. JMIR Res Protoc. 2016 Apr 19;5(2):e69. doi: 10.2196/resprot.5382.

    PubMed 27095604

Questions about this trial

What is this clinical trial studying?

A study testing Internet Obesity Treatment, Internet Obesity Treatment with MI and Contingent MI in people with Obesity, run by University of Vermont at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01232699, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.

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