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

NCT ID: NCT03914508

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2023-10-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Overweight Obesity

Keywords

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Overweight Obesity Overeating Body Mass Index Weight Treatment Cravings Intervention Behavioral Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Memory + Behavioral Weight Loss

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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M+BWL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Kerri Boutelle

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerri Boutelle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23446890 (View on PubMed)

Other Identifiers

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181514

Identifier Type: -

Identifier Source: org_study_id