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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
variable interval schedule
self-directed treatment
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    variable interval schedule

    self-directed treatment

    Arm Description

    12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period

    provision of treatment materials with instruction to work through materials at participant's own pace

    Outcomes

    Primary Outcome Measures

    body weight (kg)
    change in body weight (kg) between randomization and month-12 follow-up

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2015
    Last Updated
    June 29, 2015
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487121
    Brief Title
    Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
    Acronym
    ImWeL
    Official Title
    Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    weight loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    variable interval schedule
    Arm Type
    Experimental
    Arm Description
    12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
    Arm Title
    self-directed treatment
    Arm Type
    Active Comparator
    Arm Description
    provision of treatment materials with instruction to work through materials at participant's own pace
    Intervention Type
    Behavioral
    Intervention Name(s)
    variable interval schedule
    Intervention Description
    12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
    Intervention Type
    Behavioral
    Intervention Name(s)
    self-directed treatment
    Intervention Description
    provision of treatment materials with instruction to work through materials at participant's own pace
    Primary Outcome Measure Information:
    Title
    body weight (kg)
    Description
    change in body weight (kg) between randomization and month-12 follow-up
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35725143
    Citation
    Schneider-Worthington CR, Kinsey AW, Tan F, Zhang S, Borgatti AC, Davis AL, Dutton GR. Pretreatment and During-Treatment Weight Trajectories in Black and White Women. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S67-S74. doi: 10.1016/j.amepre.2022.01.031.
    Results Reference
    derived
    PubMed Identifier
    28806992
    Citation
    Dutton GR, Gowey MA, Tan F, Zhou D, Ard J, Perri MG, Lewis CE. Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Int J Behav Nutr Phys Act. 2017 Aug 15;14(1):107. doi: 10.1186/s12966-017-0564-1.
    Results Reference
    derived

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