NCT03914508

Brief Summary

The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

4.3 years

First QC Date

April 11, 2019

Last Update Submit

December 1, 2023

Conditions

Keywords

OverweightObesityOvereatingBody Mass IndexWeightTreatmentCravingsInterventionBehavioral Treatment

Outcome Measures

Primary Outcomes (1)

  • body mass index as measured by height and weight

    kg/m\^2

    Change from baseline at an average of 4 months and 7 months

Study Arms (1)

Memory + Behavioral Weight Loss (M+BWL)

EXPERIMENTAL

The M+BWL program will integrate memory interventions to the BWL program. The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Behavioral: Memory + Behavioral Weight Loss

Interventions

BWL and memory enhancement (M+BWL) will be integrated to capitalize on the strengths of both treatments. All participants will be taught general behavioral weight loss skills including to decrease caloric intake and increase physical activity, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss. The proposed M+BWL program provides memory interventions based on the literature, including eating attentively, memory of previous meal, memory skills for planning, effects of diet on memory and the relationship between memory and satiety. The M+BWL program will also utilize experiential learning during the group program such as practicing memory enhanced skills during eating.

Also known as: M+BWL
Memory + Behavioral Weight Loss (M+BWL)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be overweight (BMI between 25-45)
  • Participant must be between the ages of 18-65
  • Participant can read at a minimum of an 5th grade level in English
  • Participant is willing to participate and to commit to 16 weeks of treatment and attendance at assessments
  • Participants must consent to audio-taping of assessment interviews and treatment group sessions.
  • Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe.

You may not qualify if:

  • Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires.
  • Participants will not be moving out of the San Diego area for the duration of their study enrollment (7 months).
  • Participants will not be pregnant, planning to get pregnant during the 7-month study period or lactating.
  • Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
  • Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous, or would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status will not be included.
  • Participants cannot have a history of bariatric surgery
  • Participants cannot currently be enrolled in an organized weight control program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

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

OverweightObesityHyperphagiaBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Kerri Boutelle, Ph.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

June 28, 2019

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations