Improving Weight Loss Maintenance Through Alternative Schedules of Treatment (ImWeL)

June 29, 2015 updated by: Gareth R. Dutton PhD, University of Alabama at Birmingham
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 21 years-old
  • body mass index (BMI) = 28.0 - 45.0 kg/m2
  • willing to provide informed consent and accept randomization

Exclusion Criteria:

  • BMI >45 kg/m2
  • Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
  • Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: variable interval schedule
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
Behavioral: variable interval schedule
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
ACTIVE_COMPARATOR: self-directed treatment
provision of treatment materials with instruction to work through materials at participant's own pace
Behavioral: self-directed treatment
provision of treatment materials with instruction to work through materials at participant's own pace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight (kg)
Time Frame: 12 months
change in body weight (kg) between randomization and month-12 follow-up
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (ESTIMATE)

July 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DK081607 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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