Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
TRAC
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2015
CompletedFirst Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedFebruary 27, 2018
February 1, 2018
1.9 years
February 8, 2018
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
Attendance
The number of treatment visits attended
Post-Treatment (12 weeks following baseline)
Attrition
The percentage of participant attrition from each treatment arm
Change from baseline at an average of 12 weeks
Self-Monitoring Adherence
The number of days that participants self-monitor
Post-Treatment (12 weeks following baseline)
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
Measured at an average of 12 weeks following baseline
Weight Change
Weight and height will be combined to report BMI in kg/m\^2
Change from baseline at an average of 12 weeks and 24 weeks
Secondary Outcomes (2)
Working Memory
Change from baseline at an average of 12 weeks and 24 weeks
Food specific memory
Change from baseline at an average of 12 weeks and 24 weeks
Other Outcomes (1)
Restraint
Change from baseline at an average of 12 weeks and 24 weeks
Study Arms (2)
Memory Self Monitoring (MSM)
EXPERIMENTALIntervention: 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.
Caloric Self Monitoring (CSM)
ACTIVE COMPARATORIntervention: 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23446890BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerri Boutelle, PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Pediatrics and Psychiatry
Study Record Dates
First Submitted
February 8, 2018
First Posted
February 27, 2018
Study Start
January 2, 2014
Primary Completion
December 3, 2015
Study Completion
December 3, 2015
Last Updated
February 27, 2018
Record last verified: 2018-02