Clinical trial NCT05004883: Solutions for Hunger and Regulating Eating
Official title: Targeting Food Cue Responsiveness for Weight Loss
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: Food Responsiveness
Satiety Responsiveness
Weight Loss
Overeating
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.

Detailed description: The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare BWL, ROC with some aspects of BWL (ROC+) and an active comparator (AC). All treatment groups will be 1.5 hours (including weigh-ins) and will be provided in groups of 15-20 participants weekly for 4 months and twice a month for 2 months (total treatment duration = 6 months, 20 meetings). The investigators will recruit adults with overweight or obesity who are high in Food Responsiveness (FR) and will assess them at baseline, post-treatment (month 6), mid-follow-up (month 12) and follow-up (month 18).

Eligibility criteria: Inclusion Criteria:

* high Food Responsiveness
* BMI between 25kg/m\^2 and 45kg/m\^2
* able to read English at a 5th grade reading level
* willing and able to participate in assessment visits and treatment sessions, whether held in-person or via password protected Zoom meetings
* able to provide data through questionnaires
* has a smart phone through which they can complete Ecological Momentary Assessments

Exclusion Criteria:

* major medical conditions such as diabetes or recent history of coronary heart disease; symptoms of angina, stroke, osteoarthritis, osteoporosis, orthopedic problems that would limit activity during the following 18 months; or any other serious medical condition that would make physical activity unsafe
* bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, acute suicidal ideation, moderate or severe alcohol or substance use disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization in the past year)
* medical or psychological problems that could make adherence with the study protocol difficult or dangerous
* pregnant, lactating, or planning to become pregnant in the next 18 months
* participating in other weight control programs and/or taking medication for weight loss
* previous bariatric surgery
* moving out of the San Diego area for the duration of their study enrollment (18 months)

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary outcomes:
measure: Change in Food Responsiveness As Measured by the FR Scale of the AEBQ
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
measure: Change in Satiety Responsiveness As Measured by the SR Scale of the AEBQ
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
measure: Change in Inhibition As Measured by the Stop Signal Task
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
measure: Change in Restriction As Measured by the TFEQ
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
measure: Change in Caloric Intake As Measured by the DHQ III
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
measure: Change in Eating Cognitions As Measured by the FCQ-T-reduced
timeFrame: Change from baseline at an average of 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: University of California, San Diego
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: