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

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Coronary heart disease, Bulimia, others

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

Compensation: Varies

Number of Visits: 26

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to assist individuals who struggle with overeating and need to lose weight. It compares three treatments: a combination of nutrition education, stress management, and social support; a program focused on understanding and controlling eating cues (Regulation of Cues Enhanced); and a behavioral weight loss plan with diet and exercise advice (Behavioral Weight Loss Therapy). Ideal participants often feel the urge to eat, have a BMI between 25 and 45, and do not have conditions like diabetes that would make physical activity unsafe. The trial aims to identify the most effective approach to managing weight for those highly responsive to food cues. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new, effective weight management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medication for weight loss.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Weight Loss (BWL) programs are generally safe and easy to follow. These programs focus on changing eating habits, increasing physical activity, and offering dietary advice. Studies have found that they can help people lose weight steadily without dangerous side effects.

The Regulation of Cues (ROC) program increases awareness of hunger and fullness, aiming to reduce overeating by improving reactions to food signals. Research suggests this method is safe and can effectively manage weight without major negative effects.

The Nutrition, Stress Management, and Social Support program focuses on improving eating habits, managing stress, and providing social support. Learning about nutrition and stress management is usually safe and encourages healthy lifestyle changes.

Overall, these treatments have been studied for their safety and are considered low-risk. Participants generally handle them well, with no major safety concerns reported in existing studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to weight loss, combining Behavioral Weight Loss (BWL), Regulation of Cues (ROC), and Nutrition Education with Stress Management and Social Support. Unlike standard treatments that often focus on diet and exercise alone, this trial includes mindfulness practices and psychoeducation to enhance coping skills and self-monitoring. The integration of these elements aims to address the psychological and social factors influencing obesity, potentially leading to more sustainable weight loss outcomes. By capitalizing on the strengths of multiple strategies, this trial could offer a more holistic and effective solution for managing obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that Behavioral Weight Loss (BWL) programs, one of the treatment arms in this trial, can help individuals lose 8-10% of their weight in the first six months. These programs succeed by focusing on changing habits related to diet, exercise, and lifestyle. Another arm in this trial, the Regulation of Cues (ROC) Enhanced Treatment, combines ROC with aspects of BWL. Studies have found that adding the ROC program to BWL benefits those who struggle to control their response to food. This combination aids in managing reactions to food signals, making weight control easier. Evidence from trials suggests that ROC-enhanced methods can surpass standard treatments by reducing binge eating and improving weight management. ^{1 6 7 8 9}

Who Is on the Research Team?

Kerri Boutelle, Ph.D.

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9938299/

Intensive behavioral Therapy for weight loss in patients with ... Both IBT patients and matched non-IBT patients in the T2DM cohort had decreased mean weight (primary outcome) (−1.56 lbs, 95 %CI: −1.88, −1.24 vs −1.70 lbs, 95 ...

2. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/intensive-behavioral-therapy-for-obesity

Intensive Behavioral Therapy for Obesity Most people find that intensive behavioral therapy can be part of a successful weight-loss plan. This therapy doesn't use any risky weight-loss techniques. ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3233993/

Behavioral Treatment of Obesity - PMC This paper provides an overview of the structure and principles of behavioral weight loss treatment. The short- and long-term effectiveness of this approach is ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702878

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523295386

Behavioral treatment of obesity Studies suggest that behavioral treatment produces weight loss of 8–10% during the first 6 mo of treatment. Structured approaches such as meal replacements and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6800068/

Intensive Behavioral Therapy for Obesity Combined with ... INTRODUCTION. Two non-surgical interventions reliably induce a loss of 5–10% of initial body weight in persons with overweight or obesity (1).

7. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Intensive%20Behavioral%20Therapy%20for%20Obesity&NCAId=253

Decision Memo - Intensive Behavioral Therapy for Obesity The authors reported: “Behaviorally based treatment resulted in 3-kg (6.6-lb) greater weight loss in intervention than control participants ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00746265

NCT00746265 | Behavioral Treatment for Weight Loss This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical ...

9. aafp.org aafp.org/pubs/afp/issues/2019/0415/od1.html

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss interventions in adults with obesity can lead to clinically significant improvements in ...