Back to resultsPACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
Primary Purpose
Overweight, Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory + Behavioral Weight Loss
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention, Behavioral Treatment
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Memory + Behavioral Weight Loss (M+BWL)
Arm Description
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.
Outcomes
Primary Outcome Measures
body mass index as measured by height and weight
kg/m^2
Secondary Outcome Measures
Full Information
NCT ID
NCT03914508
First Posted
April 11, 2019
Last Updated
August 24, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT03914508
Brief Title
PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
Official Title
An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.
Detailed Description
The investigators have developed a new model for the treatment of obesity, which emphasizes the role of memory on food consumption in an overweight population.The pilot study will be an open label trial of a memory+behavioral weight loss (M+BWL) group treatment. The treatment will be administered in 14 group sessions over 16 weeks. The investigators will recruit adults with overweight and obesity and will assess them at baseline (prior to treatment), during treatment, post-treatment (immediately following treatment), and follow-up (3 months after treatment). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Overeating, Body Mass Index, Weight, Treatment, Cravings, Intervention, Behavioral Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Memory + Behavioral Weight Loss (M+BWL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Memory + Behavioral Weight Loss
Other Intervention Name(s)
M+BWL
Intervention Description
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.
Primary Outcome Measure Information:
Title
body mass index as measured by height and weight
Description
kg/m^2
Time Frame
Change from baseline at an average of 4 months and 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, Ph.D.
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Healthy Eating and Activity Research (CHEAR)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23446890
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.
Results Reference
background
Learn more about this trial
PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
We'll reach out to this number within 24 hrs