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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 3 months after randomization
Awards & highlights
Study Summary
This trial will compare weight change in adults with obesity who participate in 3 different internet-delivered weight loss programs to learn which is most effective. It will also study associated key behaviors and individual predictors of success.
Who is the study for?
This trial is for adults aged 18-70 with obesity (BMI of 25-45) who have regular internet access. It's not for those in other weight loss programs, pregnant or nursing individuals, people planning to move away, or those with certain medical conditions without doctor approval.Check my eligibility
What is being tested?
The study compares three online weight loss programs: STANDARD Behavioral Weight Loss Intervention and two others focusing on different cognitive strategies (PREVENT and PROMOTE). Participants will follow a year-long program with assessments at various stages.See study design
What are the potential side effects?
Potential adverse outcomes may include depression, increased body image concerns, or weight stigmatization. However, these are not direct side effects of the interventions but possible psychological impacts from participating in the weight loss programs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Weight Change Post-Treatment
Percent Weight Change at 12 months
Percent Weight Change at 3 months
+1 moreSecondary outcome measures
Change in Actigraph-measured Physical Activity (PA)
Change in Dietary Recall
Intervention Adherence - lessons viewed
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PROMOTEExperimental Treatment1 Intervention
This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and activity daily via a study website. Additionally, PROMOTE uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term benefits of healthy choices. Participants will receive cognitive training in PROMOTE prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and activity behaviors. These lessons and individualized feedback to participants are framed according to PROMOTE (i.e., focusing on achieving long-term benefits of healthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month), and feedback.
Group II: PREVENTExperimental Treatment1 Intervention
This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Additionally, PREVENT uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term negative consequences of unhealthy choices. Participants will receive training in PREVENT strategies prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants are framed according to PREVENT (i.e., focusing on avoiding long-term consequences of unhealthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training session at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.
Group III: STANDARD BehavioralActive Control1 Intervention
This is a 12-month Internet-delivered behavioral weight loss (iBWL) program that has been used in numerous studies and is currently considered our 'standard' treatment. Participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Participants will have a training session prior to beginning iBWL to learn about the website and their specific weight-related goals. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants incorporate key BWL strategies. Participants will then have a 'refresher' training session at 3 months to discuss standard behavioral weight loss strategies and help control for contact across arms. For the remainder of the program (months 4-12) participants will have monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.
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Who is running the clinical trial?
Brown UniversityOTHER
456 Previous Clinical Trials
557,994 Total Patients Enrolled
19 Trials studying Obesity
9,625 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,714 Total Patients Enrolled
446 Trials studying Obesity
588,578 Patients Enrolled for Obesity
The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,115 Total Patients Enrolled
75 Trials studying Obesity
14,780 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition where losing weight could harm me.I am between 18 and 70 years old.I am currently on medication to help me lose weight.I have a history of heart disease, diabetes, cancer, or experience dizziness and mobility issues.I do not have conditions like schizophrenia or bipolar disorder.Your Body Mass Index is between 25 and 45 kg/m2.I have had or plan to have weight-loss surgery within 18 months.
Research Study Groups:
This trial has the following groups:- Group 1: PROMOTE
- Group 2: PREVENT
- Group 3: STANDARD Behavioral
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.
Is the enrollment age for this trial inclusive of those aged above 50?
"As per the rules for inclusion, participants must be no younger than 18 and not surpass 70 years of age."
Answered by AI
Is it possible for me to participate in this clinical experiment?
"This investigation requires 360 participants who are overweight and between 18-70 years old."
Answered by AI
Are there openings for participants to join this trial?
"Affirmative, the clinicaltrials.gov website shows that this trial is actively recruiting participants. This medical investigation was initially listed on March 1st 2023 and its most recent update occurred on March 22nd of the same year. In total, 360 patients are needed from a single site to complete the study's objectives."
Answered by AI
What is the uppermost capacity of participants in this medical experiment?
"Confirmed. According to the information accessible on clinicaltrials.gov, this medical experiment started recruiting candidates in March 2021 and was last updated at the end of that month. 360 people need to take part in it across a single location."
Answered by AI
What aims does this medical research endeavor to accomplish?
"This experiment's primary outcome, to be appraised over a 3 month period post-randomization, is Percent Weight Change at 6 months. Supplementary assessments include an examination of dietary adjustment via three 24 hour diet recalls; these will be collected in person and then by phone. Data from Nutrition Data Systems for Research (NDSR 2018) will provide investigators with the capacity to gauge changes relative to energy density and overall nutrition quality as measured by Healthy Eating Index 2015 scores. Interventional adherence can also be monitored through website video viewing analytics and self-monitoring entries during the weight loss regimen."
Answered by AI
Who else is applying?
What site did they apply to?
Weight Control & Diabetes Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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