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

Overweight and Obesity Clinical Trial

— TRAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446729
• Other study ID #: 131518
• Status: Completed
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 20, 2018
• Start date: January 2, 2014
• Est. completion date: December 3, 2015

Study information

• Verified date: February 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 3, 2015
• Est. primary completion date: December 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Restraint	Restraint subscale from the Three Factor Eating Questionnaire	Change from baseline at an average of 12 weeks and 24 weeks
Primary	Attendance	The number of treatment visits attended	Post-Treatment (12 weeks following baseline)
Primary	Attrition	The percentage of participant attrition from each treatment arm	Change from baseline at an average of 12 weeks
Primary	Self-Monitoring Adherence	The number of days that participants self-monitor	Post-Treatment (12 weeks following baseline)
Primary	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
Primary	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	Working Memory	Digit Span: scaled total forward and backward score	Change from baseline at an average of 12 weeks and 24 weeks
Secondary	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.	Change from baseline at an average of 12 weeks and 24 weeks