SMART Weight Loss Management

Weight Loss Clinical Trial

— SMART  

Official title:

SMART Weight Loss Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997943
• Other study ID #: NIH NIDDK R01DK108678
• Secondary ID: R01DK108678
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: March 18, 2021

Study information

• Verified date: May 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 18, 2021
• Est. primary completion date: September 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• Step 1 Treatment: APP
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 + Coaching
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-up
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-up
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).

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2020 Feb 17:1-32. doi: 10.1080/17437199.2020.1721310. [Epub ahead of print] — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Cost effectiveness	Cost/pound lost of each study sequence embedded within the SMART design.	12 months
Primary	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