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PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking

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ClinicalTrials.gov Identifier: NCT03914508
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

Study Description
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Brief Summary:
The pilot study will be a one group treatment program and will be utilized to refine the M+BWL program.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Memory + Behavioral Weight Loss Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Memory + Behavioral Weight Loss (M+BWL)
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
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.
Other Name: M+BWL


Outcome Measures
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Primary Outcome Measures :
  1. body mass index as measured by height and weight [ Time Frame: Change from baseline at an average of 4 months and 7 months ]
    kg/m^2


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant must be overweight (BMI between 25-45)
  2. Participant must be between the ages of 18-65
  3. Participant can read at a minimum of an 5th grade level in English
  4. Participant is willing to participate and to commit to 16 weeks of treatment and attendance at assessments
  5. Participants must consent to audio-taping of assessment interviews and treatment group sessions.
  6. 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:

  1. 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.
  2. Participants will not be moving out of the San Diego area for the duration of their study enrollment (7 months).
  3. Participants will not be pregnant, planning to get pregnant during the 7-month study period or lactating.
  4. Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance.
  5. 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.
  6. Participants cannot have a history of bariatric surgery
  7. Participants cannot currently be enrolled in an organized weight control program.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914508


Contacts
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Contact: Beatriz Gasparetto, BS 858-534-8088 bgasparetto@ucsd.edu
Contact: Kerri Boutelle, Ph.D. 858-534-8037 kboutelle@ucsd.edu

Locations
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United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR) Recruiting
La Jolla, California, United States, 92093
Contact: Kerri Boutelle, PhD       kboutelle@ucsd.edu   
Principal Investigator: Kerri Boutelle, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Kerri Boutelle, Ph.D. UCSD
More Information
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Publications:

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Responsible Party: Kerri Boutelle, Prinicipal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03914508    
Other Study ID Numbers: 181514
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kerri Boutelle, University of California, San Diego:
Overweight
Obesity
Overeating
Body Mass Index
Weight
 Treatment
Cravings
Intervention
Behavioral Treatment
Additional relevant MeSH terms:
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Overweight
Body Weight