We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487121
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Gareth R. Dutton PhD, University of Alabama at Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: variable interval schedule Behavioral: self-directed treatment Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
Study Start Date : April 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. body weight (kg) [ Time Frame: 12 months ]
    change in body weight (kg) between randomization and month-12 follow-up


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Gareth R. Dutton PhD, Associate Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02487121    
Other Study ID Numbers: K23DK081607 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Gareth R. Dutton PhD, University of Alabama at Birmingham:
weight loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight