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

NCT ID: NCT01814072

Last Updated: 2023-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-09-20

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Condition 1

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 3

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Buddy Training

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 5

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 6

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 7

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Condition 8

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 9

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 11

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Buddy Training

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 13

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 14

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 15

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Condition 16

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 17

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Condition 18

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 19

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 20

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 21

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

Group Type EXPERIMENTAL

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 22

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

Group Type EXPERIMENTAL

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Condition 23

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

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

Group Type EXPERIMENTAL

12 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 12 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 25

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Condition 26

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 27

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 28

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 29

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Buddy Training

Intervention Type BEHAVIORAL

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

Condition 30

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Condition 31

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

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

Group Type EXPERIMENTAL

24 Telephone Coaching Sessions

Intervention Type BEHAVIORAL

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Intervention Type BEHAVIORAL

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

Text Messages

Intervention Type BEHAVIORAL

Participants will receive regular text messages

Recommendations to use meal replacements

Intervention Type BEHAVIORAL

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Intervention Type BEHAVIORAL

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

Interventions

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12 Telephone Coaching Sessions

Participants will receive 12 telephone coaching sessions

Intervention Type BEHAVIORAL

24 Telephone Coaching Sessions

Participants will receive 24 telephone coaching sessions

Intervention Type BEHAVIORAL

Report to Primary Care Physician

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

Intervention Type BEHAVIORAL

Text Messages

Participants will receive regular text messages

Intervention Type BEHAVIORAL

Recommendations to use meal replacements

Participants will receive recommendations from their coach to use meal replacements

Intervention Type BEHAVIORAL

Buddy Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Bonnie Spring

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bonnie Spring, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Linda Collins, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
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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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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.

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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.

Reference Type BACKGROUND
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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.

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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.

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PMID: 30212849 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 26236766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24100544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26581974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26327936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28013097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26581819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27716200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24902922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26582140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24846621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28802730 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32656994 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32347804 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

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R01DK097364-01

Identifier Type: NIH

Identifier Source: secondary_id

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NIH NIDDK R01DK097364-01

Identifier Type: -

Identifier Source: org_study_id

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