Clinical trial NCT03914508: PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
Official title: An Open Label Pilot Study of Tracking and Behavior Change for Weight Loss in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Overeating
Body Mass Index
Weight
Treatment
Cravings
Intervention
Behavioral Treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: body mass index as measured by height and weight
timeFrame: Change from baseline at an average of 4 months and 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.