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Comprehensive Weight Loss Program for Obesity (SHARE Trial)

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
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
No Placebo-Only Group

SHARE Trial 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.

SHARE Trial 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

SHARE 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
1,358 Previous Clinical Trials
1,585,829 Total Patients Enrolled
69 Trials studying Obesity
20,367 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,330 Previous Clinical Trials
4,318,125 Total Patients Enrolled
440 Trials studying Obesity
593,386 Patients Enrolled for Obesity
University of California, San DiegoLead Sponsor
1,111 Previous Clinical Trials
1,855,362 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals aged 65 or above allowed to join this investigation?

"This medical study is inviting individuals aged 18 and over, but under 65 to join."

Answered by AI

Is there an opportunity for me to participate in this scientific trial?

"This clinical trial seeks 300 individuals aged between 18 and 65 who have been diagnosed with obesity. In order to qualify, the BMI of candidates must range from 25kg/m^2 to 45 kg/m^2; participants should be capable of attending both in-person or virtual assessment visits as well as treatment sessions via password protected Zoom meetings; they also need a smartphone for Ecological Momentary Assessments and offer data through questionnaires."

Answered by AI

Is there a call for volunteers at this moment for the clinical trial?

"Affirmative. According to clinicaltrials.gov, this research project is searching for participants at present. It was originally listed on September 1st 2021 and the latest edition came out August 16th 2022 - 300 people are required from a single location."

Answered by AI

What is the total count of individuals currently involved in this research study?

"Accurately, research hosted on clinicaltrials.gov illustrates that this medical trial is still recruiting - following its initial release on September 1st 2021 and most recent update dated August 16th 2022. This study necessitates the inclusion of 300 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
UCSD Center for Healthy Eating and Activity Research (CHEAR)
~147 spots leftby Aug 2026