ObesityREBOOTNCT05326477
Predictors of Behavioral Obesity Treatment Outcomes
A study testing Behavioral weight loss treatment in people with Obesity, run by Rush University Medical Center at 1 site in United States.
Trial summary
Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral weight loss treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2023to 30 Jun 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Obesity (body mass index ≥30 kg/m2)
- Meets criteria for either the lower SES or higher SES cohort
Who cannot join
- Not fluent in English
- Change in income or financial assets exceeding ±75% of federal poverty guideline within the past 12 months, or expected in the next 6 months, if this change would result in reclassification on SES.
- Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
- Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
- Body mass index ≥60 kg/m2, due to increased injury risk with exercise
- History of bariatric surgery, or current engagement in another weight loss therapy
- Lack of reliable access to cell or landline phone
- Medical contraindications to treatment, including osteoporosis, cognitive impairment (Montreal Cognitive Assessment ≤25), active substance abuse based on the World Health Organization's ASSIST screener, lack of physician clearance for participation, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.)
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
Rush University Medical Center
Chicago, Illinois, 60612
Michele Li, MS, RD, 312-942-8260
Bradley M Appelhans, PhD
About this study
Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable environments -- account for disparities in weight loss outcomes.
Read the detailed description
Individuals of lower socioeconomic status (SES) lose only half as much weight in behavioral weight loss interventions as those of higher SES. This is a clinically meaningful difference in outcomes that has been consistently documented. The overarching aim of this project is to identify the mechanisms that account for SES-related disparities in behavioral weight loss outcomes, which would enable the development of more effective obesity treatment approaches for lower SES populations. One potential mechanism is present bias, which is a tendency to focus on one's immediate needs that may result from exposure to harsh and unpredictable environments. Present bias is a compelling candidate as a mechanism of SES-related disparities in weight loss outcomes because it is much more pronounced in lower SES populations, and it has been linked to obesity risk, maladaptive eating behaviors, and poor diet quality. A second set of potential mechanisms includes adverse daily experiences such as stress, cognitive demands, and exposure to tempting foods. Stress and cognitive demands are more prevalent or severe in the lives of lower SES populations, and can disrupt the executive functions that are important for adhering to weight control behaviors during obesity treatment.
This project will allocate equal numbers of subjects of lower and higher SES to a standard-of-care weight loss intervention. Importantly, the SES groups will be balanced with respect to ethnic/racial minority status. Weight loss outcomes and adherence to three key weight control behaviors (dietary lapses, dietary self-monitoring, and physical activity) will be rigorously measured across six months of follow up. Individual differences in present bias will be thoroughly assessed at baseline. Ecological momentary assessment will be used to capture exposure to adverse daily experiences, as well as momentary changes in present bias. Aim 1 is to test whether present bias accounts for SES-related disparities in behavioral weight loss outcomes and adherence to key weight control behaviors. Aims 2a and 2b will characterize the role of adverse daily experiences in SES-related disparities in weight loss outcomes and adherence to weight control behaviors, both overall and among present-biased individuals in particular. Aim 3 is to explore the contribution of race to SES-related disparities in weight loss outcomes, which has been challenging to elucidate in prior studies due to significant confounding of race and SES at the societal level. The results of this study could lead to a new understanding of how socioeconomic disadvantage impacts adherence to behavioral treatment for obesity, and suggest entirely new treatment approaches focused on mitigating present bias or delivering tailored intervention content during "moments of risk" for lapses in adherence.
- Conditions
- Obesity
- Being tested
- Behavioral weight loss treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss treatmentBehavioural
The weight loss intervention consists of the first 6 months of the Centers for Disease Control and Prevention's Prevent T2 program.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care behavioral weight loss treatment | Other | 6-months of group-based behavioral weight loss treatment following the Centers for Disease Control and Prevention Prevent T2 curriculum. Receives: Behavioral: Behavioral weight loss treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change, reported as a percentage of baseline weight
Measured: Months 2, 4, and 6
Secondary outcomes (3)
Adherence to dietary self-monitoring
Adherence to daily dietary self-monitoring will be scored as a binary variable (adherent vs. non-adherent) based on whether a subject recorded ≥50% of prescribed daily calorie intake goal on a given day. For example, an individual with a goal of 1350 kcal/d would be considered adherent on days in which at least 675 kcal was recorded.
Measured: Months 2, 4, and 6
Adherence to physical activity recommendations
Physical activity and sedentary time will be measured objectively through a 7-day accelerometry protocol using ActiGraph wGT3X-BT (Pensacola, FL) accelerometers. Physical activity intensity will be scored based on established cutpoints, and minutes of moderate-vigorous physical activity (counted in bouts of ≥10 mins) will be calculated on each day of the assessment period.
Measured: Months 2, 4, and 6
Frequency of dietary lapses
The occurrence of dietary lapses will be measured using ecological momentary assessment. Based on prior work, lapses are defined as "eating or drinking likely to cause weight gain, and/or put weight loss/maintenance at risk." If a lapse is endorsed at a given ambulatory assessment, subjects will classify them into one of four non-exclusive subtypes: (1) eating large portions, (2) eating at unplanned times, (3) eating foods inconsistent with weight control, or (4) eating when not hungry.
Measured: Months 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start26 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (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.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326477
- Sponsor's protocol ID
- 20042007
- Acronym
- REBOOT
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will develop an accessible archive of study data. After the study investigators have had a reasonable period of time to prepare manuscripts, study data sets will be stripped of all personal health information (PHI) to allow sharing of data without compromising subject confidentiality, privacy, and safety. All identification covered under HIPAA will be removed. A data sharing agreement will be required that will describe the conditions and restrictions of data use by external investigators; limited data access will be made available only to those users who successfully complete a rigorous approval process by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Behavioral Obesity Treatment Outcomes
- ClinicalTrials.gov ID
- NCT05326477
- Acronym / sponsor ID
- REBOOT / 20042007
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Apr 2022 (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.
Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable environments -- account for disparities in weight loss outcomes.
Detailed description
Individuals of lower socioeconomic status (SES) lose only half as much weight in behavioral weight loss interventions as those of higher SES. This is a clinically meaningful difference in outcomes that has been consistently documented. The overarching aim of this project is to identify the mechanisms that account for SES-related disparities in behavioral weight loss outcomes, which would enable the development of more effective obesity treatment approaches for lower SES populations. One potential mechanism is present bias, which is a tendency to focus on one's immediate needs that may result from exposure to harsh and unpredictable environments. Present bias is a compelling candidate as a mechanism of SES-related disparities in weight loss outcomes because it is much more pronounced in lower SES populations, and it has been linked to obesity risk, maladaptive eating behaviors, and poor diet quality. A second set of potential mechanisms includes adverse daily experiences such as stress, cognitive demands, and exposure to tempting foods. Stress and cognitive demands are more prevalent or severe in the lives of lower SES populations, and can disrupt the executive functions that are important for adhering to weight control behaviors during obesity treatment.
This project will allocate equal numbers of subjects of lower and higher SES to a standard-of-care weight loss intervention. Importantly, the SES groups will be balanced with respect to ethnic/racial minority status. Weight loss outcomes and adherence to three key weight control behaviors (dietary lapses, dietary self-monitoring, and physical activity) will be rigorously measured across six months of follow up. Individual differences in present bias will be thoroughly assessed at baseline. Ecological momentary assessment will be used to capture exposure to adverse daily experiences, as well as momentary changes in present bias. Aim 1 is to test whether present bias accounts for SES-related disparities in behavioral weight loss outcomes and adherence to key weight control behaviors. Aims 2a and 2b will characterize the role of adverse daily experiences in SES-related disparities in weight loss outcomes and adherence to weight control behaviors, both overall and among present-biased individuals in particular. Aim 3 is to explore the contribution of race to SES-related disparities in weight loss outcomes, which has been challenging to elucidate in prior studies due to significant confounding of race and SES at the societal level. The results of this study could lead to a new understanding of how socioeconomic disadvantage impacts adherence to behavioral treatment for obesity, and suggest entirely new treatment approaches focused on mitigating present bias or delivering tailored intervention content during "moments of risk" for lapses in adherence.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care behavioral weight loss treatment | Other | Behavioral: Behavioral weight loss treatment6-months of group-based behavioral weight loss treatment following the Centers for Disease Control and Prevention Prevent T2 curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Obesity (body mass index ≥30 kg/m2)
- Meets criteria for either the lower SES or higher SES cohort
Key exclusion criteria (8 listed)
- Not fluent in English
- Change in income or financial assets exceeding ±75% of federal poverty guideline within the past 12 months, or expected in the next 6 months, if this change would result in reclassification on SES.
- Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
- Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
- Body mass index ≥60 kg/m2, due to increased injury risk with exercise
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 |
|---|---|---|
| Behavioral weight loss treatmentThe weight loss intervention consists of the first 6 months of the Centers for Disease Control and Prevention's Prevent T2 program. | Behavioural | Standard-of-care behavioral weight loss treatment |
Primary outcome
Weight change
Time frame: Months 2, 4, and 6
Weight change, reported as a percentage of baseline weight
3 secondary outcomes
Adherence to dietary self-monitoring
Time frame: Months 2, 4, and 6
Adherence to physical activity recommendations
Time frame: Months 2, 4, and 6
Frequency of dietary lapses
Time frame: Months 2, 4, and 6
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 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. The investigators will develop an accessible archive of study data. After the study investigators have had a reasonable period of time to prepare manuscripts, study data sets will be stripped of all personal health information (PHI) to allow sharing of data without compromising subject confidentiality, privacy, and safety. All identification covered under HIPAA will be removed. A data sharing agreement will be required that will describe the conditions and restrictions of data use by external investigators; limited data access will be made available only to those users who successfully complete a rigorous approval process by the investigators.
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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 Behavioral weight loss treatment in people with Obesity, run by Rush University Medical Center 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 3 inclusion and 8 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 11 Mar 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?
Contact Bradley M Appelhans, PHD (312-942-3477, brad_appelhans@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Months 2, 4, and 6). 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 11 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.