PACIFIC-FIT: Providing Adults Collabora… | Clinical Trial

Key information

Conditions

Overweight Body Weight Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Memory + Behavioral Weight Loss

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.

Other names: M+BWL

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Apr 16, 2019
Registry last updated: Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed