Overweight and ObesityTRACNCT03446729
Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
A study testing Guided Self-Help Behavioral Weight Loss in people with Overweight and Obesity, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Guided Self-Help Behavioral Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2014to 3 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Guided Self-Help Behavioral Weight Loss
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Help Behavioral Weight LossBehavioural
Also called gshBWL
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.
| Study group | Role | What they receive |
|---|---|---|
| Memory Self Monitoring (MSM) | Experimental | 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. Receives: Behavioral: Guided Self-Help Behavioral Weight Loss |
| Caloric Self Monitoring (CSM) | Active comparator | 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. Receives: Behavioral: Guided Self-Help Behavioral Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
The number of treatment visits attended
Measured: Post-Treatment (12 weeks following baseline)
Attrition
The percentage of participant attrition from each treatment arm
Measured: Change from baseline at an average of 12 weeks
Self-Monitoring Adherence
The number of days that participants self-monitor
Measured: 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: Measured at an average of 12 weeks following baseline
Weight Change
Weight and height will be combined to report BMI in kg/m^2
Measured: Change from baseline at an average of 12 weeks and 24 weeks
Secondary outcomes (2)
Working Memory
Digit Span: scaled total forward and backward score
Measured: Change from baseline at an average of 12 weeks and 24 weeks
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.
Measured: Change from baseline at an average of 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start2 Jan 2014
- Primary completion3 Dec 2015
- Study completion3 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446729
- Sponsor's protocol ID
- 131518
- Acronym
- TRAC
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23446890
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
- ClinicalTrials.gov ID
- NCT03446729
- Acronym / sponsor ID
- TRAC / 131518
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 3 Dec 2015 (actual)
- Study completion
- 3 Dec 2015 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory Self Monitoring (MSM) | Experimental | Behavioral: Guided Self-Help Behavioral Weight LossIntervention: 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 comparator | Behavioral: Guided Self-Help Behavioral Weight LossIntervention: 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Help Behavioral Weight LossAlso: gshBWLGuided 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. | Behavioural | Caloric Self Monitoring (CSM), Memory Self Monitoring (MSM) |
Primary outcome
Attendance
Time frame: Post-Treatment (12 weeks following baseline)
The number of treatment visits attended
Attrition
Time frame: Change from baseline at an average of 12 weeks
The percentage of participant attrition from each treatment arm
Self-Monitoring Adherence
Time frame: Post-Treatment (12 weeks following baseline)
The number of days that participants self-monitor
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
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
2 secondary outcomes
Working Memory
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Background: PubMed 23446890Robinson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Boutelle, PhD principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help Behavioral Weight Loss in people with Overweight and Obesity, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: Post-Treatment (12 weeks following baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.