Evidence map›Paper›PMID 31129369›Full record

ArticleContemporary clinical trials2019

SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

Angela Fidler Pfammatter, Inbal Nahum-Shani, Margaret DeZelar, Laura Scanlan, H Gene McFadden, Juned Siddique, Donald Hedeker, Bonnie Spring

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01814072 phase2 / phase3completednot on this map

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

TypeinterventionalSponsorNorthwestern UniversityRan2013 to 2017Enrolled562ConditionsWeight LossArms12 Telephone Coaching Sessions, 24 Telephone Coaching Sessions, Report to Primary Care Physician, Text Messages, Recommendations to use meal replacements
NCT02997943 nacompletednot on this map

SMART Weight Loss Management

TypeinterventionalSponsorNorthwestern UniversityRan2017 to 2021Enrolled400ConditionsWeight LossArmsStep 1 Treatment: APP, Step 1 Treatment: APP + Coaching, Step 2 Treatment Strategy: Modest Step-up, Step 2 Treatment Strategy: Vigorous Step-up
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  20. Digitally characterizing the dynamics of multiple health behavior change.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Angela Fidler PfammatterFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States. Electronic address: angela@northwestern.edu.
Inbal Nahum-ShaniSurvey Research Center, Institute for Social Research, University of Michigan Ann Arbor, Ann Arbor, MI, United States.
Margaret DeZelarFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.
Laura ScanlanFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.
H Gene McFaddenFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.
Juned SiddiqueFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.
Donald HedekerUniversity of Chicago, Department of Public Health Sciences, Chicago, IL, United States.
Bonnie SpringFeinberg School of Medicine, Department of Preventive Medicine, Northwestern University, Chicago, IL, United States.

Funding

Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LEONIDAS C. PLATANIAS · 1993 to 2026
$153.9M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Novel Methods for Intensive Longitudinal Data in SMART Studies of Drug Abuse and HIVR01DA039901 · NIDA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ALMIRALL, DANIEL, NAHUM-SHANI, INBAL BILLIE · 2015 to 2024
$5.4M
SMART Weight Loss ManagementR01DK108678 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI NAHUM-SHANI, INBAL BILLIE, SPRING, BONNIE · 2016 to 2020
$3.5M
Opt-IN: Optimizing INtensive Lifestyle Intervention for Weight LossR01DK097364 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI COLLINS, LINDA M, SPRING, BONNIE · 2012 to 2016
$3.0M
NCATS NIH HHS UL1 TR001422NCI NIH HHS P30 CA060553NHLBI NIH HHS L30 HL143668NIDA NIH HHS R01 DA039901NIDDK NIH HHS R01 DK097364NIDDK NIH HHS R01 DK108678
6 · The paper itself

Abstract

backgroundStepped care is a rational resource allocation approach to reduce population obesity. Evidence is lacking to guide decisions on use of low cost treatment components such as mobile health (mHealth) tools without compromising weight loss of those needing more expensive traditional treatment components (e.g., coaching, meal replacement). A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care intervention that incorporates mHealth and traditional treatment components.

objectiveThe primary aim tests the non-inferiority of app alone, compared to app plus coaching, as first line obesity treatment, measured by weight change from baseline to 6 months. Secondary aims are to identify the best tactic to address early treatment non-response and the optimal treatment sequence for resource efficient weight loss. STUDY

designFour hundred participants, 18-60 years old with Body Mass Index between 27 and 45 kg/m SIGNIFICANCE: Results will inform construction of an obesity treatment algorithm that balances weight loss outcomes with resource consumption.

Indexed as

AdolescentAdultEquivalence Trials as TopicFemaleHumansMaleMentoringMiddle AgedMobile ApplicationsObesityRandomized Controlled Trials as TopicTreatment OutcomeWeight LossWeight Reduction ProgramsYoung AdultmHealthObesityOptimizationResource allocationStepped careWeight loss

Identifiers

PMID31129369
PMCPMC6624080

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.