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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training; Behavioral: Text Messages; Behavioral: 24 Telephone Coaching Sessions

Detailed Description

The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).

• Study Type: Interventional
• Enrollment (Actual): 562
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 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:

• 18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

32

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Condition 1; 1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician
EXPERIMENTAL: Condition 2; 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; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy
EXPERIMENTAL: Condition 3; 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; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 4; 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; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 5; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy
EXPERIMENTAL: Condition 6; 1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements
EXPERIMENTAL: Condition 7; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 8; 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; Participants will receive 12 telephone coaching sessions; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 9; 1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 10; 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: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 11; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 12; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 13; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars	Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 14; 1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements	Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 15; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages	Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 16; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars	Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 17; 1) Lifestyle Core; 2) 12 Telephone Coaching Sessions	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions
EXPERIMENTAL: Condition 18; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy
EXPERIMENTAL: Condition 19; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 20; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 21; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy
EXPERIMENTAL: Condition 22; 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; Participants will have a report detailing their weight loss progress sent to their primary care physician
EXPERIMENTAL: Condition 23; 1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages	Behavioral: 12 Telephone Coaching Sessions; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 24; 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; Participants will receive 12 telephone coaching sessions; Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages
EXPERIMENTAL: Condition 25; 1) Lifestyle Core; 2) 24 telephone coaching sessions	Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 26; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars	Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 27; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars	Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 28; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements	Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 29; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 30; 1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 31; 1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages	Behavioral: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions
EXPERIMENTAL: Condition 32; 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: Report to Primary Care Physician; Participants will have a report detailing their weight loss progress sent to their primary care physician; Behavioral: Recommendations to use meal replacements; Participants will receive recommendations from their coach to use meal replacements; Behavioral: Buddy Training; Participants will have a buddy that will be trained via webinars to be a supportive buddy; Behavioral: Text Messages; Participants will receive regular text messages; Behavioral: 24 Telephone Coaching Sessions; Participants will receive 24 telephone coaching sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention for <$500	Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Adherence	Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)	6 months
Self-monitoring Adherence	Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity	6 months
Self-efficacy	Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity	6 months
Self-Regulation	Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire	6 months
Supportive Accountability	Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support	6 months
Facilitation	Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory	6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Penn State University
• Investigators: Principal Investigator: Linda Collins, PhD, Penn State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Circulation. 2015 Nov 10;132(19):e233.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Contemp Clin Trials. 2015 Nov;45(Pt B):468-469.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): September 20, 2017
• Study Completion (ACTUAL): September 20, 2017

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (ESTIMATE): March 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: NIH NIDDK R01DK097364-01; R01DK097364-01 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No