Comprehensive Weight Loss Program for Obesity

(SHARE Trial)

Overseen By Kerri Boutelle, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 6 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kerri Boutelle, Ph.D.

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for individuals with obesity, specifically those who have a BMI between 25 and 45 kg/m^2 and are highly responsive to food. Participants must be able to attend sessions in-person or online, complete questionnaires, read English at a 5th grade level, and use a smartphone for assessments. Exclusions include eating disorders like bulimia or anorexia, severe mental health issues, substance abuse problems, pregnancy plans within the next 18 months, previous bariatric surgery or major medical conditions.

Inclusion Criteria

High Food Responsiveness

Able to read English at a 5th grade reading level

Able to provide data through questionnaires

Exclusion Criteria

Moving out of the San Diego area for the duration of their study enrollment (18 months)

I am not part of any weight control programs or taking weight loss medication.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ROC+, an active comparator, or Behavioral Weight Loss (BWL) in weekly sessions for 4 months and twice a month for 2 months

6 months

20 visits (in-person)

Follow-up

Participants are monitored for changes in caloric intake, satiety responsiveness, BMI, and other measures

12 months

Assessments at 6, 12, and 18 months

Treatment Details

Interventions

• Behavioral Weight Loss
• Nutrition Education
• Regulation of Cues Enhanced
• Stress Management and Social Support

Trial Overview The study tests ROC+ (a program combining nutrition education with stress management and social support) against an active comparator (AC) and standard Behavioral Weight Loss (BWL). It aims to see which is more effective for people who respond strongly to food cues. The interventions involve educational sessions on healthy eating habits as well as strategies to manage stress and social situations related to eating.

Participant Groups

Group I: Regulation of Cues Enhanced Treatment Experimental Treatment 1 Intervention

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.

Group II: Nutrition, Stress Management, and Social Support Active Control 1 Intervention

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

Group III: Behavioral Weight Loss Active Control 1 Intervention

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

Behavioral Weight Loss is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Weight Loss Therapy for:

• Obesity
• Weight Loss Maintenance
• Type 2 Diabetes Prevention

Approved in European Union as Intensive Behavioral Therapy for Obesity for:

• Obesity
• Weight Loss Maintenance
• Type 2 Diabetes Prevention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+