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Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching (TRAC)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided Self-Help Behavioral Weight Loss
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participant must be overweight (BMI between 25-40)
  2. Participant must be between the ages of 18-55
  3. Participant can read at a minimum of an 5th grade level in English
  4. Participant is willing to participate and to commit to 12 weeks of treatment and attendance at assessments

Exclusion Criteria:

  1. Participant is unable to exercise (ex., due to physical or medical reasons)
  2. Major psychiatric disorder diagnoses, including an eating disorder
  3. Diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet is needed
  4. Participant who takes medications that would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Memory Self Monitoring (MSM)

    Caloric Self Monitoring (CSM)

    Arm Description

    Intervention: Guided self-help Behavioral Weight Loss. The MSM group is assigned to self-monitor in "habit books" what they consume in their previous meal immediately prior to each meal, similar to other studies exploring the effect of episodic meal memory on food intake.

    Intervention: Guided self-help Behavioral Weight Loss. The CSM group is assigned to self-monitor what food they consume, and the associated caloric content after each meal in their "habit books" in line with traditional BWL self-monitoring.

    Outcomes

    Primary Outcome Measures

    Attendance
    The number of treatment visits attended
    Attrition
    The percentage of participant attrition from each treatment arm
    Self-Monitoring Adherence
    The number of days that participants self-monitor
    Acceptability
    Average of likert ratings of self-monitoring method, was it "easier," "more helpful," or "more convenient" than any methods participants may have used to self-monitor in the past
    Weight Change
    Weight and height will be combined to report BMI in kg/m^2

    Secondary Outcome Measures

    Working Memory
    Digit Span: scaled total forward and backward score
    Food specific memory
    A food version of the California Verbal Learning Test. Sum of words recalled across the five recall trials of list A (high calorie food, low calorie food, neutral words) as a measure of global index of verbal learning ability.

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    February 20, 2018
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03446729
    Brief Title
    Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
    Acronym
    TRAC
    Official Title
    Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2014 (Actual)
    Primary Completion Date
    December 3, 2015 (Actual)
    Study Completion Date
    December 3, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this application is to pilot test and evaluate the acceptability and efficacy of a program to facilitate weight loss by enhancing memory for a recently consumed meal.
    Detailed Description
    Once enrolled, all participants will receive behavioral weight loss treatment. Treatment will be 12 weeks in duration and will consist of 7 sessions. The content of sessions will provide the main elements described in behavioral therapy programs for obesity, based on empirical literature. Participants will be provided handouts, and the handout content will be based on our clinic treatment manual and published behavior therapy protocols. The program will be administered in individual 30-60-min sessions with a behavioral coach meeting every other week. This program emphasizes self-monitoring of food intake. It also emphasizes gradual weight loss, increasing physical activity, and improving diet through permanent lifestyle changes. Program topics include: self-monitoring of eating behavior, physical activity, changing the home environment and nutrition education. All treatment sessions will be conducted by licensed clinical health psychologists or psychology doctoral level students with experience in leading weight loss interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Memory Self Monitoring (MSM)
    Arm Type
    Experimental
    Arm Description
    Intervention: Guided self-help Behavioral Weight Loss. The MSM group is assigned to self-monitor in "habit books" what they consume in their previous meal immediately prior to each meal, similar to other studies exploring the effect of episodic meal memory on food intake.
    Arm Title
    Caloric Self Monitoring (CSM)
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Guided self-help Behavioral Weight Loss. The CSM group is assigned to self-monitor what food they consume, and the associated caloric content after each meal in their "habit books" in line with traditional BWL self-monitoring.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Guided Self-Help Behavioral Weight Loss
    Other Intervention Name(s)
    gshBWL
    Intervention Description
    Guided self-help Behavioral Weight Loss including 7 visits over 12 weeks. The treatment content includes self-monitoring, healthy eating, stimulus control, increasing physical activity, reducing sedentary activity, planning ahead for high-risk situations, and relapse prevention. The 7 visits are conducted with a behavioral coach to give participants educational materials and to promote accountability. The behavioral coach's role in the gshBWL program is to measure participant weight, collect self-monitoring booklets, clarify materials, and problem-solve barriers to adherence.
    Primary Outcome Measure Information:
    Title
    Attendance
    Description
    The number of treatment visits attended
    Time Frame
    Post-Treatment (12 weeks following baseline)
    Title
    Attrition
    Description
    The percentage of participant attrition from each treatment arm
    Time Frame
    Change from baseline at an average of 12 weeks
    Title
    Self-Monitoring Adherence
    Description
    The number of days that participants self-monitor
    Time Frame
    Post-Treatment (12 weeks following baseline)
    Title
    Acceptability
    Description
    Average of likert ratings of self-monitoring method, was it "easier," "more helpful," or "more convenient" than any methods participants may have used to self-monitor in the past
    Time Frame
    Measured at an average of 12 weeks following baseline
    Title
    Weight Change
    Description
    Weight and height will be combined to report BMI in kg/m^2
    Time Frame
    Change from baseline at an average of 12 weeks and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Working Memory
    Description
    Digit Span: scaled total forward and backward score
    Time Frame
    Change from baseline at an average of 12 weeks and 24 weeks
    Title
    Food specific memory
    Description
    A food version of the California Verbal Learning Test. Sum of words recalled across the five recall trials of list A (high calorie food, low calorie food, neutral words) as a measure of global index of verbal learning ability.
    Time Frame
    Change from baseline at an average of 12 weeks and 24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Restraint
    Description
    Restraint subscale from the Three Factor Eating Questionnaire
    Time Frame
    Change from baseline at an average of 12 weeks and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participant must be overweight (BMI between 25-40) Participant must be between the ages of 18-55 Participant can read at a minimum of an 5th grade level in English Participant is willing to participate and to commit to 12 weeks of treatment and attendance at assessments Exclusion Criteria: Participant is unable to exercise (ex., due to physical or medical reasons) Major psychiatric disorder diagnoses, including an eating disorder Diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet is needed Participant who takes medications that would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerri Boutelle, PhD
    Organizational Affiliation
    University of California, San Diego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23446890
    Citation
    Robinson E, Aveyard P, Daley A, Jolly K, Lewis A, Lycett D, Higgs S. Eating attentively: a systematic review and meta-analysis of the effect of food intake memory and awareness on eating. Am J Clin Nutr. 2013 Apr;97(4):728-42. doi: 10.3945/ajcn.112.045245. Epub 2013 Feb 27.
    Results Reference
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    Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching

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