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

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Memory + Behavioral Weight Loss

• Registration Number: NCT03914508
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-06-28
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Memory + Behavioral Weight Loss (M+BWL)	Memory + Behavioral Weight Loss	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.

Primary Outcome Measures

Name	Time	Method
body mass index as measured by height and weight	Change from baseline at an average of 4 months and 7 months	kg/m\^2

Trial Locations

Locations (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR); 🇺🇸 La Jolla, California, United States