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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK108678 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step 1 Treatment: APP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight at 6 months | Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale | baseline, 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in weight at 12 months | Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale | baseline, 12 months |
| Cost effectiveness | Cost/pound lost of each study sequence embedded within the SMART design. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Spring, PhD | Northwestern University | Principal Investigator |
| Inbal Nahum-Shani, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31129369 | Background | 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. | |
| 27663578 | Background | Nahum-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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2024 | |
| Unrelease | Nov 18, 2024 | |
| Release | Nov 18, 2024 | |
| Reset | Dec 11, 2024 | |
| Release | May 5, 2025 | |
| Reset | May 20, 2025 | |
| Release | Jun 3, 2025 | |
| Reset | Jun 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2024 | Nov 18, 2024 | |||
| Nov 18, 2024 |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Step 1 Treatment: APP + Coaching | Behavioral | 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. |
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| Step 2 Treatment Strategy: Modest Step-up | Behavioral | 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. |
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| Step 2 Treatment Strategy: Vigorous Step-up | Behavioral | 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). |
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| 12 months |
| 27973672 | Background | Spring 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. |
| 31436465 | Background | Spring 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. |
| 29604043 | Background | Walton 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. |
| 29552270 | Background | Almirall 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. |
| 29362728 | Background | Wagner 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. |
| 29551330 | Background | Welch 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. |
| 30777156 | Background | Booth 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. |
| 28029718 | Background | Nahum-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. |
| 26638988 | Background | Lu 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. |
| 31973666 | Background | Spring 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. |
| 26243172 | Background | Ertefaie 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. |
| 38744428 | Derived | Spring 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. |
| 38375882 | Derived | Metzendorf 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. |
| Dec 11, 2024 |
| May 5, 2025 | May 20, 2025 |
| Jun 3, 2025 | Jun 18, 2025 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |