ObesitySTELLARNCT05687604
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
A study testing multiple behavior change therapy in people with Obesity and Smoking Cessation, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Smoking Cessation, Physical Inactivity
- What is being tested?
- multiple behavior change therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Northwestern Medicine patient
- Over 18 years old
- Meet at least 1 of the following 3 criteria:
- Engage in <150 min/week of physical activity
- BMI of ≥25
- Report that they currently smoke or smoked within the last year
Show all 10Show fewer
- Diagnosed with any cancer (except non-melanoma skin)
- Ability to attend telehealth visits either via landline, cell phone, smartphone, tablet, laptop, or desktop computer
- 3 months post curative intent treatment if BMI of ≥25 or engage in <150 min/week of physical activity
- Post curative intent treatment if they currently smoke or smoked within the last year
Who cannot join
- Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention.
- Limited level of oral and written English or Spanish
- Cognitively impaired adults
- Prisoners
- Participants will be excluded from the physical activity and weight loss interventions (but not the smoking cessation component) for:
- Absolute contraindications to exercise (i.e., acute myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension), metastatic disease or planned elective surgery
- Pregnant or plans to become pregnant.
- Individuals engaging in the physical activity or weight loss interventions must pass pre- physical activity participation screening or obtain medical clearance
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
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
Bonnie Sring, Ph.D., 312-908-2293, bspring@northwestern.edu
Bonnie Spring, PhD, ABPP
About this study
The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors.
The main question[s] STELLAR aims to answer are:
Read more
- How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment.
- Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
- Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication.
Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and/or 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.
Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only.
Read the detailed description
The goal of this clinical trial is to decrease adverse outcomes and improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients.
The main question[s] STELLAR aims to answer are:
- How best to combine three existing effective cancer risk behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment program within the existing NMHC environment.
- Evaluate the reach of the FACILITATED program. We will look at the number, proportion, and representativeness of individuals who are willing to participate in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
- Evaluate the effects of the FACILITATED program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, healthcare utilization, patient-provider communication, cost and health outcomes (symptoms and quality of life).
Participants will be recruited through several channels (MyNM, direct outreach from research staff, EDW). Interested patients will then be randomly assigned to the STELLAR program arm, or Enhanced Usual Care. Participants in the STELLAR program will be enrolled for a year into the program. Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and/or 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the FACILITATED group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.
Researchers will compare the FACILITATED intervention group to the SELF GUIDED group to see if the FACILITATED intervention group is able to reach more participants that Self Guided only.
- Conditions
- Obesity, Smoking Cessation, Physical Inactivity
- Being tested
- multiple behavior change therapy
- Medical subject headings
- Obesity, Smoking Cessation, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple behavior change therapyBehavioural
goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 16 telehealth sessions with study staff across the 12 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| FACILITATED Program | Active comparator | STELLAR arm participants will receive goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 12 telehealth sessions with study staff across 6 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and/or 9 months. Receives: Behavioral: multiple behavior change therapy |
| SELF GUIDED Program | No intervention | Patients in the EUC group will receive informational packets about their risk behaviors - obesity, physical inactivity, and/or smoking. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Effectiveness will be primarily evaluated through effects on behavioral change, which will serve as the primary outcomes: For 7-day point-prevalence smoking abstinence at 6 months (self-report of any smoking even a puff in the 7 days before the 6- month follow-up visit). For continuous outcomes (e.g., weight loss) we will use linear regression models adjusting for baseline values. For moderate to vigorous physical activity, the outcome will be transformed (e.g., logarithmically) to stabilize the variance and to satisfy the normality assumption. Secondary analyses for each outcome will adjust for the number or combination of risk factors.
Measured: 6 Months
Secondary outcomes (9)
Reach
- We will evaluate the Reach of the risk behavior screening system by assessing the number of cancer survivors exposed to EHR screening and the proportion and representativeness of those who enroll in the study and are randomized. B) We will also evaluate the Reach of the STELLAR intervention by assessing the proportion and representativeness (in terms of disease characteristics, socioeconomic status, telehealth access, technology literacy, race/ethnicity, and insurance status) of those randomized to active intervention who attend at least one treatment session.
Measured: Baseline
Smoking
Assessed using Timeline Followback interview, participants who report any smoking, even a puff, in the 7 days prior to the visit will be classified as a person that currently smokes
Measured: baseline, 3, 6 and/or 9 months
Body Weight
patient reported body weight in lbs.
Measured: baseline, 3, 6 and 9/or months
Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity
Patient-reported weekly amount of moderate intensity physical activity in days and minutes will be assessed at each time point. Participants will be asked in the last 7 days, how many days they engaged in moderate intensity activity. Then on the days they were active, about how many minutes they were active (Less than 30 Minutes; 30 minutes to less than 1 hour; 1 hour to less than 1.5 hours; 1.5 hours to less than 2 hours; 2 hours to less than 2.5 hours; Over 2.5 hours)
Measured: baseline, 3, 6 and/or 9 months
Total Healthcare Cost and Amount of Patient Care Utilization
The following data will be extracted from the medical record: unplanned, all-cause hospital admissions; potentially avoidable, all-cause emergency department use; 7-day hospital readmissions; and use of triage clinic. Since not all patients receive all their care within the NMHC system, they will also be asked to self-report these data.
Measured: baseline, 3, 6 and/or 9 months
Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey)
Relevant subscales from AHRQ's Consumer Assessment of Healthcare Providers \& Systems (CAHPS) Cancer Care Survey will be used: The specific subscales include:
- How Well the Cancer Care Team Communicates with Patients. This subscale asks the participant about provider communication on a 4-point scale from "never" to "always" in terms of how well the provider explained things in an easy-to-understand way, listened carefully to patient, showed respect to patient, and spent enough time with patient.
- Availability of Interpreters. This subscale asks yes/no if the patient ever needed an interpreter for visits, and if yes, how often they received one on a 4-point scale from "never" to "always"
- Overall Rating of Cancer Team and Cancer Care. This is a single question asking patients to rate their provider on a 1-10 scale with 1 being the worst provider possible and 10 being the best provider possible
Measured: baseline, 3, 6 and/or 9 months
Rating of Patient-Provider Communication and Shared Decision-Making as Measured by The Interpersonal Process of Care (IPC32)
The Interpersonal Process of Care (IPC32), will assess the patient's thoughts on physician-patient interpersonal interactions. The IPC evaluates:
- The patients' assessment of their physician's communication quality by asking how often physicians perform certain activities (e.g. eliciting concerns, explanations) on a scale from 1 = never to 5 = always.
- The patient's assessment of how often their provider includes them in decisions about their own health (shared-decision making) on a scale from 1 = never to 5 = always.
- The patient's assessment of their provider's interpersonal style based on how often the provider displayed certain behaviors (e.g. compassion, respect) on a scale from 1 = never to 5 = always.
Measured: baseline, 3, 6 and/or 9 months
Rating of Symptoms and Functioning as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile assesses fatigue, depression, anxiety, ability to participate in social roles and activities, sleep disturbance, physical function, and pain interference/intensity on a 1-5 rating scale with 1 being the worst rating and 5 being the best.
Measured: baseline, 3, 6 and/or 9 months
Rating of Quality of Life Using the Health Related Quality of Life Short Form (HRQOL SF-12)
Quality of Life will be assessed using the Health Related Quality of Life Short Form (HRQOL SF-12). The tool measures two independent dimensions of HRQOL: physical (physical functioning, role functioning, bodily pain, and general health) and emotional (vitality, social functioning, role functioning and mental health) as well as an aggregate score. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: baseline, 3, 6 and/or 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start24 Sep 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized control trial with 2 parallel intervention arms. One arm will be the active treatment group, and the other an enhanced usual-care control group. Assessors will be blinded to study condition, and intervention will be behavioral.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Hitsman, Northwestern University
- Investigators
- Brian Hitsman, PhD, Principal investigator, Northwestern UniversitySofia Garcia, PhD, Principal investigator, Northwestern UniversitySiobhan Phillips, PhD, Principal investigator, Northwestern UniversityBonnie Spring, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687604
- Sponsor's protocol ID
- P50CA271353
- Acronym
- STELLAR
- Status last verified
- May 2026
- First submitted
- 5 Dec 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data will be made available via a study website. Additionally, the website will contain our intervention manual and materials, templates of all study documents including the protocol, consent form, questionnaires, etc.
Publications
Spring B, Garcia SF, Daly E, Jacobs M, Jayeoba M, Jordan N, Kircher S, Kocherginsky M, Mazzetta R, Pollack T, Scanlan L, Scherr C, Hitsman B, Phillips SM. Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):83-91. doi: 10.1093/jncimonographs/lgae020.
PubMed 38924795Rendle KA, Tan ASL, Spring B, Bange EM, Lipitz-Snyderman A, Morris MJ, Makarov DV, Daly R, Garcia SF, Hitsman B, Ogedegbe O, Phillips S, Sherman SE, Stetson PD, Vachani A, Wainwright JV, Zullig LL, Bekelman JE. A Framework for Integrating Telehealth Equitably across the cancer care continuum. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):92-99. doi: 10.1093/jncimonographs/lgae021.
PubMed 38924790
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
- ClinicalTrials.gov ID
- NCT05687604
- Acronym / sponsor ID
- STELLAR / P50CA271353
- Conditions
- Obesity, Smoking Cessation, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Jan 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 improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors.
The main question[s] STELLAR aims to answer are:
- How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment.
- Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
- Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication.
Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and/or 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.
Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only.
Detailed description
The goal of this clinical trial is to decrease adverse outcomes and improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients.
The main question[s] STELLAR aims to answer are:
- How best to combine three existing effective cancer risk behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment program within the existing NMHC environment.
- Evaluate the reach of the FACILITATED program. We will look at the number, proportion, and representativeness of individuals who are willing to participate in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
- Evaluate the effects of the FACILITATED program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, healthcare utilization, patient-provider communication, cost and health outcomes (symptoms and quality of life).
Participants will be recruited through several channels (MyNM, direct outreach from research staff, EDW). Interested patients will then be randomly assigned to the STELLAR program arm, or Enhanced Usual Care. Participants in the STELLAR program will be enrolled for a year into the program. Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and/or 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the FACILITATED group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.
Researchers will compare the FACILITATED intervention group to the SELF GUIDED group to see if the FACILITATED intervention group is able to reach more participants that Self Guided only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized control trial with 2 parallel intervention arms. One arm will be the active treatment group, and the other an enhanced usual-care control group. Assessors will be blinded to study condition, and intervention will be behavioral.
| Arm | Type | Receives |
|---|---|---|
| FACILITATED Program | Active comparator | Behavioral: multiple behavior change therapySTELLAR arm participants will receive goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 12 telehealth sessions with study staff across 6 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and/or 9 months. |
| SELF GUIDED Program | No intervention | –Patients in the EUC group will receive informational packets about their risk behaviors - obesity, physical inactivity, and/or smoking. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 9 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Northwestern Medicine patient
- Over 18 years old
- Meet at least 1 of the following 3 criteria:
- Engage in <150 min/week of physical activity
- BMI of ≥25
Key exclusion criteria (8 listed)
- Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention.
- Limited level of oral and written English or Spanish
- Cognitively impaired adults
- Prisoners
- Participants will be excluded from the physical activity and weight loss interventions (but not the smoking cessation component) for:
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 |
|---|---|---|
| multiple behavior change therapygoals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 16 telehealth sessions with study staff across the 12 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 12 months. | Behavioural | FACILITATED Program |
Primary outcome
Effectiveness
Time frame: 6 Months
Effectiveness will be primarily evaluated through effects on behavioral change, which will serve as the primary outcomes: For 7-day point-prevalence smoking abstinence at 6 months (self-report of any smoking even a puff in the 7 days before the 6- month follow-up visit). For continuous outcomes (e.g., weight loss) we will use linear regression models adjusting for baseline values. For moderate to vigorous physical activity, the outcome will be transformed (e.g., logarithmically) to stabilize the variance and to satisfy the normality assumption. Secondary analyses for each outcome will adjust for the number or combination of risk factors.
9 secondary outcomes
Reach
Time frame: Baseline
Smoking
Time frame: baseline, 3, 6 and/or 9 months
Body Weight
Time frame: baseline, 3, 6 and 9/or months
Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity
Time frame: baseline, 3, 6 and/or 9 months
Total Healthcare Cost and Amount of Patient Care Utilization
Time frame: baseline, 3, 6 and/or 9 months
Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey)
Time frame: baseline, 3, 6 and/or 9 months
Rating of Patient-Provider Communication and Shared Decision-Making as Measured by The Interpersonal Process of Care (IPC32)
Time frame: baseline, 3, 6 and/or 9 months
Rating of Symptoms and Functioning as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile
Time frame: baseline, 3, 6 and/or 9 months
Rating of Quality of Life Using the Health Related Quality of Life Short Form (HRQOL SF-12)
Time frame: baseline, 3, 6 and/or 9 months
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 6 Nov 2026.
- Background: PubMed 38924795Spring B, Garcia SF, Daly E, Jacobs M, Jayeoba M, Jordan N, Kircher S, Kocherginsky M, Mazzetta R, Pollack T, Scanlan L, Scherr C, Hitsman B, Phillips SM. Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):83-91. doi: 10.1093/jncimonographs/lgae020.
- Background: PubMed 38924790Rendle KA, Tan ASL, Spring B, Bange EM, Lipitz-Snyderman A, Morris MJ, Makarov DV, Daly R, Garcia SF, Hitsman B, Ogedegbe O, Phillips S, Sherman SE, Stetson PD, Vachani A, Wainwright JV, Zullig LL, Bekelman JE. A Framework for Integrating Telehealth Equitably across the cancer care continuum. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):92-99. doi: 10.1093/jncimonographs/lgae021.
- Individual participant dataSharing planned: Yes. Deidentified study data will be made available via a study website. Additionally, the website will contain our intervention manual and materials, templates of all study documents including the protocol, consent form, questionnaires, etc.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Brian Hitsman, PhD principal investigator
Northwestern University
Sofia Garcia, PhD principal investigator
Northwestern University
Siobhan Phillips, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiple behavior change therapy in people with Obesity and Smoking Cessation, run by Northwestern University 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 10 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 6 Nov 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 Rana Mazzetta, LMSW (312-503-6595, rana.khalifeh@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05687604, which also lists 2 linked publications.
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 6 Nov 2026.