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

February 20, 2018 updated by: Kerri Boutelle, University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Memory Self Monitoring (MSM)
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.
Behavioral: Guided Self-Help Behavioral Weight Loss
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.
Other Names:
  • gshBWL
ACTIVE_COMPARATOR: Caloric Self Monitoring (CSM)
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.
Behavioral: Guided Self-Help Behavioral Weight Loss
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.
Other Names:
  • gshBWL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: Post-Treatment (12 weeks following baseline)
The number of treatment visits attended
Post-Treatment (12 weeks following baseline)
Attrition
Time Frame: Change from baseline at an average of 12 weeks
The percentage of participant attrition from each treatment arm
Change from baseline at an average of 12 weeks
Self-Monitoring Adherence
Time Frame: Post-Treatment (12 weeks following baseline)
The number of days that participants self-monitor
Post-Treatment (12 weeks following baseline)
Acceptability
Time Frame: Measured at an average of 12 weeks following baseline
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
Time Frame: Change from baseline at an average of 12 weeks and 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Memory
Time Frame: Change from baseline at an average of 12 weeks and 24 weeks
Digit Span: scaled total forward and backward score
Change from baseline at an average of 12 weeks and 24 weeks
Food specific memory
Time Frame: Change from baseline at an average of 12 weeks and 24 weeks
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.
Change from baseline at an average of 12 weeks and 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restraint
Time Frame: Change from baseline at an average of 12 weeks and 24 weeks
Restraint subscale from the Three Factor Eating Questionnaire
Change from baseline at an average of 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2014

Primary Completion (ACTUAL)

December 3, 2015

Study Completion (ACTUAL)

December 3, 2015

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (ACTUAL)

February 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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