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

December 1, 2023 updated by: Kerri Boutelle, University of California, San Diego

An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • M+BWL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at an average of 4 months and 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Kerri Boutelle, Ph.D., UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181514

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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