NCT01232699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

3.3 years

First QC Date

November 1, 2010

Last Update Submit

December 20, 2018

Conditions

Keywords

obesityweight lossinternet treatmentmotivational interviewing

Outcome Measures

Primary Outcomes (4)

  • Change in Body Weight

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

    6 months

  • Change in Body Weight

    12 months

  • Change in Body Weight

    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)

    0

Secondary Outcomes (7)

  • Adherence to Treatment Components

    6 months

  • Adherence to Treatment Components

    12 months

  • Adherence to Treatment Components

    18 months

  • Motivation Measures

    0

  • Motivation Measures

    6

  • +2 more secondary outcomes

Study Arms (3)

Internet Obesity Treatment

ACTIVE COMPARATOR

Participants will attend weekly class sessions on line and track food and exercise in an on-line journal.

Behavioral: Internet Obesity Treatment

Internet Obesity Treatment with MI

EXPERIMENTAL

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

Contingent MI

EXPERIMENTAL

Intervention is the same as for the MI arm, however participants will only receive MI if meeting certain treatment participation conditions.

Behavioral: Contingent MI

Interventions

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
Internet Obesity Treatment

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
Internet Obesity Treatment with MI
Contingent MIBEHAVIORAL

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

Also known as: iReach2
Contingent MI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for the Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Behavioral Weight Management Program/Univ of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jean R Harvey Berino, PhD.

    University of Vermont

    PRINCIPAL INVESTIGATOR
  • Delia Smith-West, PhD.

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations