PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults
1 other identifier
interventional
49
1 country
1
Brief Summary
The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
June 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2023
CompletedDecember 5, 2023
December 1, 2023
4.3 years
April 11, 2019
December 1, 2023
Conditions
Keywords
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)
EXPERIMENTALThe 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.
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.
Eligibility Criteria
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
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerri Boutelle, Ph.D.
UCSD
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