Evidence map›Paper›PMID 25633208›Full record

Trial reportContemporary clinical trials2015

Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE.

Erica G Phillips-Caesar, Ginger Winston, Janey C Peterson, Brian Wansink, Carol M Devine, Balavanketsh Kanna, Walid Michelin, Elaine Wethington, Martin Wells, James Hollenberg and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03609463 (Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.7field-weighted citation impact, top 11% of its field
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.

NCT03609463 nacompletednot on this mapstarted 2018, after this paper: background citation

Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention

TypeinterventionalSponsorChiara RafanelliRan2018 to 2020Enrolled58ConditionsDiabetes Mellitus, Type 2, Overweight and ObesityArmsSmall change intervention, Well-being intervention, Treatment as usual
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 30 citations in OpenAlex.

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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

11 authors at 3 institutions in 1 country.

Erica G Phillips-CaesarDivision of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801. Electronic address: erp2001@med.cornell.edu.
Ginger WinstonGeorge Washington University, Department of Medicine, Foggy Bottom South Pavilion, 22nd & I Street, NW Washington DC 20037.
Janey C PetersonDivision of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
Brian WansinkDepartment of Human Development, Cornell University G96 Martha Van Rensselaer Hall Ithaca, NY 14853-4401.
Carol M DevineDivision of Nutritional Sciences, Cornell University 405 Savage Hall Cornell University Ithaca, NY 14853-4401.
Balavanketsh KannaLincoln Medical and Mental Health Center for Collaborative Community Research.
Walid MichelinLincoln Medical and Mental Health Center for Collaborative Community Research.
Elaine WethingtonDepartment of Human Development, Cornell University G96 Martha Van Rensselaer Hall Ithaca, NY 14853-4401.
Martin WellsCornell University Department of Statistical Science 301 Malott Hall Ithaca, NY 14853.
James HollenbergDivision of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
Mary E CharlsonDivision of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801.
Cornell University · USLincoln Medical Center · USGeorge Washington University · US

Funding

Pilot CoreP30AG022845 · NIA · WEILL MEDICAL COLL OF CORNELL UNIV · PI Manney Carrington Reid, ELAINE WETHINGTON · 2003 to 2026
$15.2M
Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in HyP60MD003421 · NIMHD · WEILL MEDICAL COLL OF CORNELL UNIV · PI OGEDEGBE, OLUGBENGA G. · 2009 to 2013
$8.9M
SCALE: Small Changes and Lasting EffectsU01HL097843 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI CHARLSON, MARY E · 2009 to 2013
$6.5M
INSPIRE: Intervention to Support Participation in Regular Exercise in the ElderlyK23AG042869 · NIA · WEILL MEDICAL COLL OF CORNELL UNIV · PI PETERSON, JANEY CHRISTINE · 2013 to 2016
$671k
Autoregulation and Systemic Blood Pressure: A New View of Normal Tension GlaucomaR21EY018150 · NEI · WEILL MEDICAL COLL OF CORNELL UNIV · PI CHARLSON, MARY E · 2008 to 2009
$459k
NEI NIH HHS R21 EY018150NHLBI NIH HHS U01 HL097843NHLBI NIH HHS UO1 HL097843NIA NIH HHS K23 AG042869NIA NIH HHS P30 AG022845NIMHD NIH HHS P60 MD003421NIMHD NIH HHS P60 MD003421-02
6 · The paper itself

Abstract

backgroundObesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss.

methodsUsing a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant's values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months.

resultsOver 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis.

conclusionThe present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.

Indexed as

AffectFeeding BehaviorMotor ActivitySelf ConceptAdultAttitude to HealthBehavior TherapyBlack or African AmericanFemaleHispanic or LatinoHumansMaleMiddle AgedObesityQualitative ResearchTreatment Outcomeeating behaviorsmixed methodsphysical activityrandomized controlled trialsmall changesweight loss

Identifiers

PMID25633208
PMCPMC4492122
OpenAlexW2041657932

What OpenQuestion holds

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LicenceCC BY-NC
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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.