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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
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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at an average of 6 months, 9 months, 12 months, 15 months, and 18 months
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
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 moreSHARE 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
1,378 Previous Clinical Trials
1,588,209 Total Patients Enrolled
70 Trials studying Obesity
20,749 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,886 Total Patients Enrolled
447 Trials studying Obesity
588,938 Patients Enrolled for Obesity
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,335 Total Patients Enrolled
53 Trials studying Obesity
7,482 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to read English at a 5th grade reading level.I am not part of any weight control programs or taking weight loss medication.I can attend all required visits or Zoom meetings for the study.My BMI is between 25 and 45.(EMA)
The person has a smart phone that they can use to complete Ecological Momentary Assessments (EMA).I have had weight loss surgery in the past.I do not have major health issues that would make physical activity unsafe.You have a strong response to food.I can attend all required visits and sessions, either in-person or online.You are able to provide data through questionnaires.
Research Study Groups:
This trial has the following groups:- Group 1: Nutrition, Stress Management, and Social Support
- Group 2: Regulation of Cues Enhanced Treatment
- Group 3: Behavioral Weight Loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
California
Texas
Georgia
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)
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