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

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT03914508

Collaborator

(none)

100

Enrollment

Location

Arm

46.1

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jun 28, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.