NCT03446729

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 8, 2018

Last Update Submit

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)

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.

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.

Behavioral: Guided Self-Help Behavioral Weight Loss

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.

Also known as: gshBWL
Caloric Self Monitoring (CSM)Memory Self Monitoring (MSM)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kerri Boutelle, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

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