Solutions for Hunger and Regulating Eating (SHARE)

University of California San Diego

Status

Active, not recruiting

Conditions

Overweight and Obesity

Treatments

Behavioral: Nutrition Education, Stress Management and Social Support

Behavioral: Behavioral Weight Loss

Behavioral: Regulation of Cues Enhanced

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05004883

201362

Details and patient eligibility

About

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.

Full 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).

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 3 patient groups

Regulation of Cues Enhanced Treatment

Experimental group

Description:

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning, and it will be combined with aspects of BWL to capitalize on the strengths of both treatments.

Treatment:

Behavioral: Regulation of Cues Enhanced

Behavioral Weight Loss

Active Comparator group

Description:

The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Treatment:

Behavioral: Behavioral Weight Loss

Nutrition, Stress Management, and Social Support

Active Comparator group

Description:

Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.