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
About this trial
This is an interventional treatment trial for Overweight and Obesity
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
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
NCT ID
NCT03446729
First Posted
February 8, 2018
Last Updated
February 20, 2018
Sponsor
University of California, San Diego
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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