Weight LossSMARTNCT02997943
SMART Weight Loss Management
A study testing Step 1 Treatment: APP, Step 1 Treatment: APP + Coaching and Step 2 Treatment Strategy: Modest Step-up in people with Weight Loss, run by Northwestern University at 1 site in United States.
Trial summary
The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Step 1 Treatment: APP, Step 1 Treatment: APP + Coaching and Step 2 Treatment Strategy: Modest Step-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 through 60 years old
- BMI between 27 - 45 kg/m2
- < 350 lbs
- Weight stable (no loss or gain >25 lbs. for the past 6 months)
- Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change
- Own a Smartphone and be willing to install the SMART App
- Reside in the Chicago area for the duration of their participation (12 months)
Who cannot join
- Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease)
- Pregnancy, lactation, or intended pregnancy
- Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
- Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity
- Use of pacemaker or other electrical implanted device
- History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
- May not live with a current or past SMART study participant
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.
Read the detailed description
The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity. During the 12-week active intervention phase, participants will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the addition of an additional mHealth component plus a traditional weight loss intervention component. Treatment responders will continue with the same first-line treatment. Treatment response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will be re-randomized at that time.
- Conditions
- Weight Loss
- Being tested
- Step 1 Treatment: APP, Step 1 Treatment: APP + Coaching, Step 2 Treatment Strategy: Modest Step-up, Step 2 Treatment Strategy: Vigorous Step-up
- Keywords
- Obesity, Weight Loss, Diet, Physical Activity, Mobile Health
- Medical subject headings
- Weight Loss, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1 Treatment: APPBehavioural
Participants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application.
Step 1 Treatment: APP + CoachingBehavioural
Participants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application.
Step 2 Treatment Strategy: Modest Step-upBehavioural
In addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks.
Step 2 Treatment Strategy: Vigorous Step-upBehavioural
In addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements).
| Study group | Role | What they receive |
|---|---|---|
| Step 1: Optimal First Line Treatment | Experimental | Participants will first be randomized to an optimal first line treatment in order to compare APP vs. APP + coaching. Participants assigned to Step 1 treatment "APP" will receive a study-specific smartphone application. Participants assigned to Step 1 treatment "APP + coaching" will receive a study-specific smartphone application plus 12 weekly telephone coaching sessions. Receives: Behavioral: Step 1 Treatment: APP; Behavioral: Step 1 Treatment: APP + Coaching |
| Step 2: Optimal Strategy to Address Nonresponse | Experimental | Beginning at week 2, participants who are identified as treatment non-responders will be re-randomized in order to compare two strategies to address non-response: a modest step-up or vigorous step-up treatment augmentation tactic. Step 2 treatment strategy: modest step-up will include provision of an additional mHealth intervention component (push notifications). Step 2 treatment strategy vigorous step-up will include provision of an additional mHealth intervention component (push notifications), plus a traditional weight loss intervention component (coaching, meal replacements). Participants will continue to receive their first line treatment. Receives: Behavioral: Step 2 Treatment Strategy: Modest Step-up; Behavioral: Step 2 Treatment Strategy: Vigorous Step-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight at 6 months
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start19 Jun 2017
- Primary completion17 Sep 2020
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Northwestern UniversityInbal Nahum-Shani, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997943
- Sponsor's protocol ID
- NIH NIDDK R01DK108678
- Other IDs
- R01DK108678
- Acronym
- SMART
- Status last verified
- May 2021
- First submitted
- 5 Dec 2016
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23.
PubMed 31129369Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
PubMed 27663578Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available.
PubMed 27973672Spring B, Stump T, Penedo F, Pfammatter AF, Robinson JK. Toward a health-promoting system for cancer survivors: Patient and provider multiple behavior change. Health Psychol. 2019 Sep;38(9):840-850. doi: 10.1037/hea0000760.
PubMed 31436465Walton A, Nahum-Shani I, Crosby L, Klasnja P, Murphy S. Optimizing Digital Integrated Care via Micro-Randomized Trials. Clin Pharmacol Ther. 2018 Jul;104(1):53-58. doi: 10.1002/cpt.1079. Epub 2018 Apr 19.
PubMed 29604043Almirall D, Kasari C, McCaffrey DF, Nahum-Shani I. Developing Optimized Adaptive Interventions in Education. J Res Educ Eff. 2018;11(1):27-34. doi: 10.1080/19345747.2017.1407136. Epub 2017 Nov 29.
PubMed 29552270Wagner B 3rd, Liu E, Shaw SD, Iakovlev G, Zhou L, Harrington C, Abowd G, Yoon C, Kumar S, Murphy S, Spring B, Nahum-Shani I. ewrapper: Operationalizing engagement strategies in mHealth. Proc ACM Int Conf Ubiquitous Comput. 2017 Sep;2017:790-798. doi: 10.1145/3123024.3125612.
PubMed 29362728Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15.
PubMed 29551330Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
PubMed 30777156Nahum-Shani I, Ertefaie A, Lu XL, Lynch KG, McKay JR, Oslin DW, Almirall D. A SMART data analysis method for constructing adaptive treatment strategies for substance use disorders. Addiction. 2017 May;112(5):901-909. doi: 10.1111/add.13743. Epub 2017 Feb 18.
PubMed 28029718Lu X, Nahum-Shani I, Kasari C, Lynch KG, Oslin DW, Pelham WE, Fabiano G, Almirall D. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med. 2016 May 10;35(10):1595-615. doi: 10.1002/sim.6819. Epub 2015 Dec 6.
PubMed 26638988Spring B, Champion KE, Acabchuk R, Hennessy EA. Self-regulatory behaviour change techniques in interventions to promote healthy eating, physical activity, or weight loss: a meta-review. Health Psychol Rev. 2021 Dec;15(4):508-539. doi: 10.1080/17437199.2020.1721310. Epub 2020 Feb 17.
PubMed 31973666Ertefaie A, Wu T, Lynch KG, Nahum-Shani I. Identifying a set that contains the best dynamic treatment regimes. Biostatistics. 2016 Jan;17(1):135-48. doi: 10.1093/biostatistics/kxv025. Epub 2015 Aug 3.
PubMed 26243172Spring B, Pfammatter AF, Scanlan L, Daly E, Reading J, Battalio S, McFadden HG, Hedeker D, Siddique J, Nahum-Shani I. An Adaptive Behavioral Intervention for Weight Loss Management: A Randomized Clinical Trial. JAMA. 2024 Jul 2;332(1):21-30. doi: 10.1001/jama.2024.0821.
PubMed 38744428Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Weight Loss Management
- ClinicalTrials.gov ID
- NCT02997943
- Acronym / sponsor ID
- SMART / NIH NIDDK R01DK108678
- Conditions
- Weight Loss
- Keywords
- Obesity, Weight Loss, Diet, Physical Activity, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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 overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.
Detailed description
The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity. During the 12-week active intervention phase, participants will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the addition of an additional mHealth component plus a traditional weight loss intervention component. Treatment responders will continue with the same first-line treatment. Treatment response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will be re-randomized at that time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step 1: Optimal First Line Treatment | Experimental | Behavioral: Step 1 Treatment: APP, Behavioral: Step 1 Treatment: APP + CoachingParticipants will first be randomized to an optimal first line treatment in order to compare APP vs. APP + coaching. Participants assigned to Step 1 treatment "APP" will receive a study-specific smartphone application. Participants assigned to Step 1 treatment "APP + coaching" will receive a study-specific smartphone application plus 12 weekly telephone coaching sessions. |
| Step 2: Optimal Strategy to Address Nonresponse | Experimental | Behavioral: Step 2 Treatment Strategy: Modest Step-up, Behavioral: Step 2 Treatment Strategy: Vigorous Step-upBeginning at week 2, participants who are identified as treatment non-responders will be re-randomized in order to compare two strategies to address non-response: a modest step-up or vigorous step-up treatment augmentation tactic. Step 2 treatment strategy: modest step-up will include provision of an additional mHealth intervention component (push notifications). Step 2 treatment strategy vigorous step-up will include provision of an additional mHealth intervention component (push notifications), plus a traditional weight loss intervention component (coaching, meal replacements). Participants will continue to receive their first line treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 through 60 years old
- BMI between 27 - 45 kg/m2
- < 350 lbs
- Weight stable (no loss or gain >25 lbs. for the past 6 months)
- Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change
Key exclusion criteria (7 listed)
- Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease)
- Pregnancy, lactation, or intended pregnancy
- Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
- Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity
- Use of pacemaker or other electrical implanted device
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 |
|---|---|---|
| Step 1 Treatment: APPParticipants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application. | Behavioural | Step 1: Optimal First Line Treatment |
| Step 1 Treatment: APP + CoachingParticipants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application. | Behavioural | Step 1: Optimal First Line Treatment |
| Step 2 Treatment Strategy: Modest Step-upIn addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks. | Behavioural | Step 2: Optimal Strategy to Address Nonresponse |
| Step 2 Treatment Strategy: Vigorous Step-upIn addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements). | Behavioural | Step 2: Optimal Strategy to Address Nonresponse |
Primary outcome
Change in weight at 6 months
Time frame: baseline, 6 months
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 31129369Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23.
- Background: PubMed 27663578Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
- Background: PubMed 27973672Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available.
- Background: PubMed 31436465Spring B, Stump T, Penedo F, Pfammatter AF, Robinson JK. Toward a health-promoting system for cancer survivors: Patient and provider multiple behavior change. Health Psychol. 2019 Sep;38(9):840-850. doi: 10.1037/hea0000760.
- Background: PubMed 29604043Walton A, Nahum-Shani I, Crosby L, Klasnja P, Murphy S. Optimizing Digital Integrated Care via Micro-Randomized Trials. Clin Pharmacol Ther. 2018 Jul;104(1):53-58. doi: 10.1002/cpt.1079. Epub 2018 Apr 19.
- Background: PubMed 29552270Almirall D, Kasari C, McCaffrey DF, Nahum-Shani I. Developing Optimized Adaptive Interventions in Education. J Res Educ Eff. 2018;11(1):27-34. doi: 10.1080/19345747.2017.1407136. Epub 2017 Nov 29.
- Background: PubMed 29362728Wagner B 3rd, Liu E, Shaw SD, Iakovlev G, Zhou L, Harrington C, Abowd G, Yoon C, Kumar S, Murphy S, Spring B, Nahum-Shani I. ewrapper: Operationalizing engagement strategies in mHealth. Proc ACM Int Conf Ubiquitous Comput. 2017 Sep;2017:790-798. doi: 10.1145/3123024.3125612.
- Background: PubMed 29551330Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15.
- Background: PubMed 30777156Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
- Background: PubMed 28029718Nahum-Shani I, Ertefaie A, Lu XL, Lynch KG, McKay JR, Oslin DW, Almirall D. A SMART data analysis method for constructing adaptive treatment strategies for substance use disorders. Addiction. 2017 May;112(5):901-909. doi: 10.1111/add.13743. Epub 2017 Feb 18.
- Background: PubMed 26638988Lu X, Nahum-Shani I, Kasari C, Lynch KG, Oslin DW, Pelham WE, Fabiano G, Almirall D. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med. 2016 May 10;35(10):1595-615. doi: 10.1002/sim.6819. Epub 2015 Dec 6.
- Background: PubMed 31973666Spring B, Champion KE, Acabchuk R, Hennessy EA. Self-regulatory behaviour change techniques in interventions to promote healthy eating, physical activity, or weight loss: a meta-review. Health Psychol Rev. 2021 Dec;15(4):508-539. doi: 10.1080/17437199.2020.1721310. Epub 2020 Feb 17.
- Individual participant dataSharing planned: No
Related trials for Weight Loss
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Active, not recruiting
A Multidisciplinary Weight Loss Program at AUB-MC
Obesity, Weight Loss
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
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. This study is not recruiting at the moment.
Bonnie Spring, PhD principal investigator
Northwestern University
Inbal Nahum-Shani, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step 1 Treatment: APP, Step 1 Treatment: APP + Coaching and Step 2 Treatment Strategy: Modest Step-up in people with Weight Loss, 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 18 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight at 6 months (time frame: baseline, 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 NCT02997943, which also lists 15 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 18 May 2021.