ObesityNCT05799846
Cognitive Strategies for Weight Loss
A study testing Standard Behavioral Weight Loss Intervention, PREVENT Behavioral Weight Loss Intervention and PROMOTE Behavioral Weight Loss Intervention in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Behavioral Weight Loss Intervention, PREVENT Behavioral Weight Loss Intervention and PROMOTE Behavioral Weight Loss Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.
Who cannot join
- Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.
- Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
Kathryn E Demos McDermott, PhD, 4017938939, kathryn_demos@brown.edu
About this study
Official title: Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are:
- Which of the three Internet-delivered weight loss programs results in the greatest weight loss?
- How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms?
- What individual characteristics predict success in each arm?
- What are the underlying mechanisms of each approach?
- Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns).
Read more
Participants will:
- signed informed consent
- complete a baseline assessment
- be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE
- complete a training workshop to learn arm-specific cognitive strategies
- complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons
- complete an assessment at 3 months (during treatment)
- complete a refresher workshop on arm-specific cognitive strategies at 3 months
- complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment
- Conditions
- Obesity
- Being tested
- Standard Behavioral Weight Loss Intervention, PREVENT Behavioral Weight Loss Intervention, PROMOTE Behavioral Weight Loss Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral Weight Loss InterventionBehavioural
12-month online behavioral weight loss intervention
PREVENT Behavioral Weight Loss InterventionBehavioural
12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity
PROMOTE Behavioral Weight Loss InterventionBehavioural
12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight
| Study group | Role | What they receive |
|---|---|---|
| STANDARD Behavioral | Active comparator | 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. Receives: Behavioral: Standard Behavioral Weight Loss Intervention |
| PREVENT | Experimental | 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. Receives: Behavioral: PREVENT Behavioral Weight Loss Intervention |
| PROMOTE | Experimental | 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. Receives: Behavioral: PROMOTE Behavioral Weight Loss Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Change at 3 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Measured: 3 months after randomization
Percent Weight Change at 6 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Measured: 6 months after randomization
Percent Weight Change at 12 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Measured: 12 months after randomization
Percent Weight Change Post-Treatment
Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)
Measured: 18 months after randomization
Secondary outcomes (4)
Change in Actigraph-measured Physical Activity (PA)
To address Secondary Aim 1, physical activity (PA) will be objectively-measured for 1 week at baseline, 3m, 12m, and 18m using ActigraphGT9X Link. Participants will be instructed to wear the accelerometer on their waist during all waking hours, exclusive of bathing and swimming, for 7 consecutive days. This monitor uses a validated triaxial accelerometer and proprietary data filtering technology to estimate free-living PA and sedentary behaviors. Accelerometer data will be processed and analyzed using Actigraph's ActiLife software. Data will be considered valid if the monitor was worn for more than 10 hours on more than 4 days (including one or more weekend day). Intensity will be assessed as average counts per minute (cpm) and previously validated cut points (Freedson et al., 1998) will be used to identify bout-related moderate-to-vigorous intensity PA (greater than or equal to 1952 cpm accumulated in bouts greater than or equal to 10 min) and sedentary time (less than 100 cpm).
Measured: 12 months after randomization
Change in Dietary Recall
Diet will be measured through 3, non-consecutive 24-hour diet recalls at baseline, 3m, 12m, and 18m. Recalls will be collected on two weekdays and one weekend at each time point with the first recall collected during the in-person assessment and the subsequent two recalls collected via phone. A trained interviewer will collect recalls using Nutrition Data Systems for Research (NDSR 2018; Nutrition Coordinating Center, University of Minnesota). NDSR uses a multipass method which provides participants multiple opportunities to recall each consumed food/beverage and reduces reporting biases. Given issues with use of dietary recalls to determine absolute energy intake, NDSR output will be used to examine changes in energy density and diet quality, as measured by the Healthy Eating Index, 2015 (HEI-2015). Component scores will highlight changes in intake of fruits and vegetables, whole grains, and lean proteins as well as calories from alcohol, added sugars and energy-dense snacks.
Measured: 12 months after randomization
Intervention Adherence - lessons viewed
Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of intervention videos viewed.
Measured: 12 months after randomization
Intervention Adherence - self-monitoring
Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of self-monitoring entries during the weight loss program.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Mar 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brown University, University of Minnesota
- Responsible party
- Principal investigator, Kathryn E. Demos, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799846
- Sponsor's protocol ID
- 1809657-4
- Other IDs
- R01DK128412
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response
- ClinicalTrials.gov ID
- NCT05799846
- Acronym / sponsor ID
- 1809657-4
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Brown University, University of Minnesota
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are:
- Which of the three Internet-delivered weight loss programs results in the greatest weight loss?
- How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms?
- What individual characteristics predict success in each arm?
- What are the underlying mechanisms of each approach?
- Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns).
Participants will:
- signed informed consent
- complete a baseline assessment
- be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE
- complete a training workshop to learn arm-specific cognitive strategies
- complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons
- complete an assessment at 3 months (during treatment)
- complete a refresher workshop on arm-specific cognitive strategies at 3 months
- complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STANDARD Behavioral | Active comparator | Behavioral: Standard Behavioral Weight Loss InterventionThis 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. |
| PREVENT | Experimental | Behavioral: PREVENT Behavioral Weight Loss InterventionThis 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. |
| PROMOTE | Experimental | Behavioral: PROMOTE Behavioral Weight Loss InterventionThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.
Key exclusion criteria (2 listed)
- Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.
- Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Behavioral Weight Loss Intervention12-month online behavioral weight loss intervention | Behavioural | STANDARD Behavioral |
| PREVENT Behavioral Weight Loss Intervention12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity | Behavioural | PREVENT |
| PROMOTE Behavioral Weight Loss Intervention12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight | Behavioural | PROMOTE |
Primary outcome
Percent Weight Change at 3 months
Time frame: 3 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Percent Weight Change at 6 months
Time frame: 6 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Percent Weight Change at 12 months
Time frame: 12 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Percent Weight Change Post-Treatment
Time frame: 18 months after randomization
Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)
4 secondary outcomes
Change in Actigraph-measured Physical Activity (PA)
Time frame: 12 months after randomization
Change in Dietary Recall
Time frame: 12 months after randomization
Intervention Adherence - lessons viewed
Time frame: 12 months after randomization
Intervention Adherence - self-monitoring
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Weight Loss Intervention, PREVENT Behavioral Weight Loss Intervention and PROMOTE Behavioral Weight Loss Intervention in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Change at 3 months (time frame: 3 months after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.