Clinical trial NCT03446729: Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
Official title: Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance
timeFrame: Post-Treatment (12 weeks following baseline)
measure: Attrition
timeFrame: Change from baseline at an average of 12 weeks
measure: Self-Monitoring Adherence
timeFrame: Post-Treatment (12 weeks following baseline)
measure: Acceptability
timeFrame: Measured at an average of 12 weeks following baseline
measure: Weight Change
timeFrame: Change from baseline at an average of 12 weeks and 24 weeks
Secondary outcomes:
measure: Working Memory
timeFrame: Change from baseline at an average of 12 weeks and 24 weeks
measure: Food specific memory
timeFrame: Change from baseline at an average of 12 weeks and 24 weeks
Other outcomes:
measure: Restraint
timeFrame: Change from baseline at an average of 12 weeks and 24 weeks
Locations:
Study officials:
affiliation: University of California, San Diego
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.