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SMART Weight Loss Management (SMART)

Primary Purpose

Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Step 1 Treatment: APP

Step 1 Treatment: APP + Coaching

Step 2 Treatment Strategy: Modest Step-up

Step 2 Treatment Strategy: Vigorous Step-up

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Obesity, Weight Loss, Diet, Physical Activity, Mobile Health

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Step 1: Optimal First Line Treatment

Step 2: Optimal Strategy to Address Nonresponse

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in weight at 6 months

Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02997943

First Posted

December 5, 2016

Last Updated

May 17, 2021

Sponsor

Northwestern University

Collaborators

University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT02997943

Brief Title

SMART Weight Loss Management

Acronym

SMART

Official Title

SMART Weight Loss Management

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

June 19, 2017 (Actual)

Primary Completion Date

September 17, 2020 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss

Keywords

Obesity, Weight Loss, Diet, Physical Activity, Mobile Health

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Step 1: Optimal First Line Treatment

Arm Type

Experimental

Arm Description

Arm Title

Step 2: Optimal Strategy to Address Nonresponse

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Step 1 Treatment: APP

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Step 1 Treatment: APP + Coaching

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Step 2 Treatment Strategy: Modest Step-up

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Step 2 Treatment Strategy: Vigorous Step-up

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in weight at 6 months

Description

Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale

Time Frame

baseline, 6 months

Other Pre-specified Outcome Measures:

Title

Change in weight at 12 months

Description

Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale

Time Frame

baseline, 12 months

Title

Cost effectiveness

Description

Cost/pound lost of each study sequence embedded within the SMART design.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bonnie Spring, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Inbal Nahum-Shani, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31129369

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.

Results Reference

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PubMed Identifier

27663578

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.

Results Reference

background

PubMed Identifier

27973672

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. No abstract available.

Results Reference

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PubMed Identifier

31436465

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.

Results Reference

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PubMed Identifier

29604043

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.

Results Reference

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PubMed Identifier

29552270

Citation

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.

Results Reference

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PubMed Identifier

29362728

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.

Results Reference

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PubMed Identifier

29551330

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.

Results Reference

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PubMed Identifier

30777156

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.

Results Reference

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PubMed Identifier

28029718

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.

Results Reference

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PubMed Identifier

26638988

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.

Results Reference

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PubMed Identifier

31973666

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. 2021 Dec;15(4):508-539. doi: 10.1080/17437199.2020.1721310. Epub 2020 Feb 17.

Results Reference

background

PubMed Identifier

26243172

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.

Results Reference

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SMART Weight Loss Management

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