Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

NCT01814072 | Completed Phase 2 Results DMC

• 2 other identifiers: NIH NIDDK R01DK097364-01R01DK097364-01
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

• Weight Change (kg) From Baseline to Month 6, Main Effect of Time

  Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

  From Baseline to Month 6

• Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction

  Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

  From Baseline to Month 6

Secondary Outcomes (1)

• Intervention for <$500

  6 months

Other Outcomes (6)

• Treatment Adherence

  6 months

• Self-monitoring Adherence

  6 months

• Self-efficacy

  6 months

Study Arms (32)

Condition 1

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician

Condition 2

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 3

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Buddy Training

Condition 4

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements

Condition 5

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Buddy Training

Condition 6

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements

Condition 7

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages

Condition 8

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 9

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician

Condition 10

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 11

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Buddy Training

Condition 12

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements

Condition 13

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Buddy Training

Condition 14

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements

Condition 15

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages

Condition 16

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 17

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions

Behavioral: 12 Telephone Coaching Sessions

Condition 18

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 19

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Buddy Training

Condition 20

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements

Condition 21

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training

Condition 22

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements

Behavioral: Report to Primary Care Physician

Condition 23

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages

Condition 24

EXPERIMENTAL

1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 25

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone coaching sessions

Behavioral: 24 Telephone Coaching Sessions

Condition 26

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Condition 27

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Buddy Training

Condition 28

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements

Condition 29

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training

Condition 30

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements

Condition 31

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages

Condition 32

EXPERIMENTAL

1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

Interventions

12 Telephone Coaching Sessions BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Condition 1; Condition 17; Condition 18; Condition 19; Condition 2; Condition 20; Condition 23; Condition 24; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

24 Telephone Coaching Sessions BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 25; Condition 26; Condition 27; Condition 28; Condition 29; Condition 30; Condition 31; Condition 32; Condition 9

Report to Primary Care Physician BEHAVIORAL

Participants will have a report detailing their weight loss progress sent to their primary care physician

Condition 1; Condition 10; Condition 11; Condition 12; Condition 2; Condition 21; Condition 22; Condition 23; Condition 24; Condition 29; Condition 3; Condition 30; Condition 31; Condition 32; Condition 4; Condition 9

Text Messages BEHAVIORAL

Participants will receive regular text messages

Condition 11; Condition 12; Condition 15; Condition 16; Condition 19; Condition 20; Condition 23; Condition 24; Condition 27; Condition 28; Condition 3; Condition 31; Condition 32; Condition 4; Condition 7; Condition 8

Recommendations to use meal replacements BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 10; Condition 12; Condition 14; Condition 16; Condition 18; Condition 2; Condition 20; Condition 24; Condition 26; Condition 28; Condition 30; Condition 32; Condition 4; Condition 6; Condition 8

Buddy Training BEHAVIORAL

Participants will have a buddy that will be trained via webinars to be a supportive buddy

Condition 10; Condition 11; Condition 13; Condition 16; Condition 18; Condition 19; Condition 2; Condition 21; Condition 24; Condition 26; Condition 27; Condition 29; Condition 3; Condition 32; Condition 5; Condition 8

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• and 60 years old
• BMI 25-40 kg/m2
• Weight stable (no loss or gain \>25 lbs for the past 6 months)
• Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
• Own a Smartphone and be willing to install the Opt-IN app
• Able to use the app to record dietary intake and weight onto the Smartphone
• "Buddy" participants must:
• years of age or older
• Have access to a computer and internet
• Be willing to undergo "Buddy Training" and participate in 4 webinars
• Be willing to provide support and encouragement to the participant

You may not qualify if:

• Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
• History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
• Use an assistive device for mobility (e.g., wheelchair, walker, cane)
• Plantar fasciitis
• Hospitalization for a psychiatric disorder within the past 5 years
• At risk for adverse cardiovascular (CVD) events with moderate intensity activity
• Cannot read the study questionnaires
• Committed to following an incompatible dietary regimen
• Not be pregnant, trying to get pregnant, or lactating
• Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
• Low motivation to change
• Cannot live with a current or past Opt-IN participant

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Penn State University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (33)

• Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

  PMID: 17466815 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.

  PMID: 27663578 BACKGROUND

• Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, Piper ME, Collins LM. Implementing Clinical Research Using Factorial Designs: A Primer. Behav Ther. 2017 Jul;48(4):567-580. doi: 10.1016/j.beth.2016.12.005. Epub 2017 Jan 7.

  PMID: 28577591 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.

  PMID: 31129369 BACKGROUND

• Nahum-Shani I, Dziak JJ, Collins LM. Multilevel factorial designs with experiment-induced clustering. Psychol Methods. 2018 Sep;23(3):458-479. doi: 10.1037/met0000128. Epub 2017 Apr 6.

  PMID: 28383950 BACKGROUND

• Terry PE, Brown N, Arnett DK, Cushman M, Spring B, Halpern SD, Burke LE, Grossmeier J, Goetzel R, Lang J, Calitz C, Terry PE, Sanchez E. The Art of Health Promotion ideas for improving health outcomes. Am J Health Promot. 2016 Sep;30(7):563-82. doi: 10.1177/0890117116668866. No abstract available.

  PMID: 27670659 BACKGROUND

• Pellegrini CA, Conroy DE, Phillips SM, Pfammatter AF, McFadden HG, Spring B. Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application. J Nutr Educ Behav. 2018 Jan;50(1):56-61.e1. doi: 10.1016/j.jneb.2016.12.004.

  PMID: 29325663 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.

  PMID: 29551330 BACKGROUND

• Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available.

  PMID: 26271892 BACKGROUND

• Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.

  PMID: 30212849 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.

  PMID: 30777156 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.

  PMID: 27973672 BACKGROUND

• Hoffman SA, Ledford G, Cameron KA, Phillips SM, Pellegrini CA. A qualitative exploration of social and environmental factors affecting diet and activity in knee replacement patients. J Clin Nurs. 2019 Apr;28(7-8):1156-1163. doi: 10.1111/jocn.14719. Epub 2018 Dec 10.

  PMID: 30461097 BACKGROUND

• Hekler EB, Michie S, Pavel M, Rivera DE, Collins LM, Jimison HB, Garnett C, Parral S, Spruijt-Metz D. Advancing Models and Theories for Digital Behavior Change Interventions. Am J Prev Med. 2016 Nov;51(5):825-832. doi: 10.1016/j.amepre.2016.06.013.

  PMID: 27745682 BACKGROUND

• Kheirkhahan M, Tudor-Locke C, Axtell R, Buman MP, Fielding RA, Glynn NW, Guralnik JM, King AC, White DK, Miller ME, Siddique J, Brubaker P, Rejeski WJ, Ranshous S, Pahor M, Ranka S, Manini TM. Actigraphy features for predicting mobility disability in older adults. Physiol Meas. 2016 Oct;37(10):1813-1833. doi: 10.1088/0967-3334/37/10/1813. Epub 2016 Sep 21.

  PMID: 27653966 BACKGROUND

• Collins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S197-214. doi: 10.1007/s10461-015-1145-4.

  PMID: 26238037 BACKGROUND

• Piper ME, Schlam TR, Cook JW, Smith SS, Bolt DM, Loh WY, Mermelstein R, Collins LM, Fiore MC, Baker TB. Toward precision smoking cessation treatment I: Moderator results from a factorial experiment. Drug Alcohol Depend. 2017 Feb 1;171:59-65. doi: 10.1016/j.drugalcdep.2016.11.025. Epub 2016 Nov 25.

  PMID: 28013098 BACKGROUND

• Piper ME, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, Mermelstein R, Schlam TR, Cook JW, Jorenby DE, Loh WY, Baker TB. Identifying effective intervention components for smoking cessation: a factorial screening experiment. Addiction. 2016 Jan;111(1):129-41. doi: 10.1111/add.13162. Epub 2015 Nov 19.

  PMID: 26582269 BACKGROUND

• Collins LM, Dziak JJ, Kugler KC, Trail JB. Factorial experiments: efficient tools for evaluation of intervention components. Am J Prev Med. 2014 Oct;47(4):498-504. doi: 10.1016/j.amepre.2014.06.021. Epub 2014 Aug 1.

  PMID: 25092122 BACKGROUND

• Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11.

  PMID: 28494136 BACKGROUND

• Pellegrini CA, Pfammatter AF, Conroy DE, Spring B. Smartphone applications to support weight loss: current perspectives. Adv Health Care Technol. 2015 Jul;1:13-22. doi: 10.2147/AHCT.S57844.

  PMID: 26236766 BACKGROUND

• Spring B, Ockene JK, Gidding SS, Mozaffarian D, Moore S, Rosal MC, Brown MD, Vafiadis DK, Cohen DL, Burke LE, Lloyd-Jones D; American Heart Association Behavior Change Committee of the Council on Epidemiology and Prevention, Council on Lifestyle and Cardiometabolic Health, Council for High Blood Pressure Research, and Council on Cardiovascular and Stroke Nursing. Better population health through behavior change in adults: a call to action. Circulation. 2013 Nov 5;128(19):2169-76. doi: 10.1161/01.cir.0000435173.25936.e1. Epub 2013 Oct 7. No abstract available.

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• Baker TB, Collins LM, Mermelstein R, Piper ME, Schlam TR, Cook JW, Bolt DM, Smith SS, Jorenby DE, Fraser D, Loh WY, Theobald WE, Fiore MC. Enhancing the effectiveness of smoking treatment research: conceptual bases and progress. Addiction. 2016 Jan;111(1):107-16. doi: 10.1111/add.13154. Epub 2015 Nov 19.

  PMID: 26581974 BACKGROUND

• Pellegrini CA, Hoffman SA, Daly ER, Murillo M, Iakovlev G, Spring B. Acceptability of smartphone technology to interrupt sedentary time in adults with diabetes. Transl Behav Med. 2015 Sep;5(3):307-14. doi: 10.1007/s13142-015-0314-3.

  PMID: 26327936 BACKGROUND

• Piper ME, Cook JW, Schlam TR, Smith SS, Bolt DM, Collins LM, Mermelstein R, Fiore MC, Baker TB. Toward precision smoking cessation treatment II: Proximal effects of smoking cessation intervention components on putative mechanisms of action. Drug Alcohol Depend. 2017 Feb 1;171:50-58. doi: 10.1016/j.drugalcdep.2016.11.027. Epub 2016 Nov 24.

  PMID: 28013097 BACKGROUND

• Schlam TR, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, Mermelstein R, Piper ME, Cook JW, Jorenby DE, Loh WY, Baker TB. Comparative effectiveness of intervention components for producing long-term abstinence from smoking: a factorial screening experiment. Addiction. 2016 Jan;111(1):142-55. doi: 10.1111/add.13153. Epub 2015 Nov 19.

  PMID: 26581819 BACKGROUND

• Watkins E, Newbold A, Tester-Jones M, Javaid M, Cadman J, Collins LM, Graham J, Mostazir M. Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression. BMC Psychiatry. 2016 Oct 6;16(1):345. doi: 10.1186/s12888-016-1054-8.

  PMID: 27716200 BACKGROUND

• Collins LM, Nahum-Shani I, Almirall D. Optimization of behavioral dynamic treatment regimens based on the sequential, multiple assignment, randomized trial (SMART). Clin Trials. 2014 Aug;11(4):426-434. doi: 10.1177/1740774514536795. Epub 2014 Jun 5.

  PMID: 24902922 BACKGROUND

• Cook JW, Collins LM, Fiore MC, Smith SS, Fraser D, Bolt DM, Baker TB, Piper ME, Schlam TR, Jorenby D, Loh WY, Mermelstein R. Comparative effectiveness of motivation phase intervention components for use with smokers unwilling to quit: a factorial screening experiment. Addiction. 2016 Jan;111(1):117-28. doi: 10.1111/add.13161. Epub 2015 Nov 19.

  PMID: 26582140 BACKGROUND

• Pellegrini CA, Hoffman SA, Collins LM, Spring B. Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol. Contemp Clin Trials. 2014 Jul;38(2):251-9. doi: 10.1016/j.cct.2014.05.007. Epub 2014 May 17.

  PMID: 24846621 BACKGROUND

• Pellegrini CA, Hoffman SA, Collins LM, Spring B. Corrigendum to "Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol" [Contemp. Clin. Trials 38 (2014) 251-259]. Contemp Clin Trials. 2015 Nov;45(Pt B):468-469. doi: 10.1016/j.cct.2015.09.001. Epub 2015 Nov 29. No abstract available.

  PMID: 28802730 BACKGROUND

• Spring B, Pfammatter AF, Marchese SH, Stump T, Pellegrini C, McFadden HG, Hedeker D, Siddique J, Jordan N, Collins LM. A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study. Obesity (Silver Spring). 2020 Sep;28(9):1652-1662. doi: 10.1002/oby.22915. Epub 2020 Jul 12.

  PMID: 32656994 DERIVED

• Pfammatter AF, Marchese SH, Pellegrini C, Daly E, Davidson M, Spring B. Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research. JMIR Form Res. 2020 May 13;4(5):e16297. doi: 10.2196/16297.

  PMID: 32347804 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bonnie Spring, PhD, ABPP
• Organization: Northwestern University Feinberg School of Medicine

bspring@northwestern.edu

312-908-2293

Study Officials

• Bonnie Spring, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Linda Collins, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: September 1, 2013
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: February 1, 2023
• Results First Posted: January 5, 2021

Record last verified: 2023-01

Locations

US (1)