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Comprehensive Weight Loss Program for Obesity (SHARE Trial)

N/A
Recruiting
Led By Kerri Boutelle, Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Previous bariatric surgery
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
Awards & highlights

Summary

This trial will compare the weight-loss effects of ROC+ to those of an active comparator and behavioral weight loss for people who are highly responsive to food.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this trial focuses on behavioral interventions rather than medications or invasive procedures, side effects may include psychological discomfort from lifestyle changes. Physical activity components might cause mild musculoskeletal strain in some participants.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had weight loss surgery in the past.
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I do not have major health issues that would make physical activity unsafe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Mass Index
Secondary outcome measures
Change in Caloric Intake As Measured by the DHQ III
Change in Eating Cognitions As Measured by the FCQ-T-reduced
Change in Food Responsiveness As Measured by the FR Scale of the AEBQ
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Regulation of Cues Enhanced TreatmentExperimental Treatment1 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 SupportActive Control1 Intervention
Nutrition Education, Stress Management and Social Support will be covered. Mindfulness will be practiced in every session.
Group III: Behavioral Weight LossActive Control1 Intervention
The BWL program will include dietary recommendations, physical activity recommendations, and behavioral change recommendations.

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER
1,395 Previous Clinical Trials
1,553,025 Total Patients Enrolled
70 Trials studying Obesity
20,749 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,802 Total Patients Enrolled
454 Trials studying Obesity
588,965 Patients Enrolled for Obesity
University of California, San DiegoLead Sponsor
1,135 Previous Clinical Trials
1,550,944 Total Patients Enrolled
53 Trials studying Obesity
7,482 Patients Enrolled for Obesity

Media Library

Behavioral Weight Loss Clinical Trial Eligibility Overview. Trial Name: NCT05004883 — N/A
Obesity Research Study Groups: Nutrition, Stress Management, and Social Support, Regulation of Cues Enhanced Treatment, Behavioral Weight Loss
Obesity Clinical Trial 2023: Behavioral Weight Loss Highlights & Side Effects. Trial Name: NCT05004883 — N/A
Behavioral Weight Loss 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004883 — N/A
~122 spots leftby Aug 2026
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