Evidence map›Paper›PMID 35378301›Full record

ArticleContemporary clinical trials2022

The EVO study protocol for a randomized controlled evaluation trial of an optimized weight management intervention.

Angela Fidler Pfammatter, Samuel L Battalio, Charlie Olvera, Margaret DeZelar, Dominique Moore, Laura Scanlan, Juned Siddique, Bonnie Spring, Su-Hsin Chang

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
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

9 authors.

Angela Fidler PfammatterDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States. Electronic address: angela@northwestern.edu.
Samuel L BattalioDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Charlie OlveraDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Margaret DeZelarDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Dominique MooreDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Laura ScanlanDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Juned SiddiqueDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Bonnie SpringDepartment of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Su-Hsin ChangDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO, United States.

Funding

Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Research Design, Data, and Analytics CoreP30DK092949 · NIDDK · UNIVERSITY OF CHICAGO · PI MILDA Renne SAUNDERS · 2011 to 2026
$10.0M
SMART Weight Loss ManagementR01DK108678 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI NAHUM-SHANI, INBAL BILLIE, SPRING, BONNIE · 2016 to 2020
$3.5M
Evaluating the EVO treatment optimized for resource constraints: Elements Vital to treat ObesityR01DK125749 · NIDDK · UNIVERSITY OF TENNESSEE KNOXVILLE · PI PFAMMATTER, ANGELA FIDLER · 2020 to 2025
$2.7M
NCATS NIH HHS UL1 TR001422NHLBI NIH HHS L30 HL143668NIDDK NIH HHS P30 DK092949NIDDK NIH HHS R01 DK108678NIDDK NIH HHS R01 DK125749
6 · The paper itself

Abstract

backgroundObesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss.

objectiveThe aim of the remotely conducted EVO trial is to test the non-inferiority of EVO against DPP. We will conduct economic evaluations alongside the trial to estimate delivery and patient costs, cost-effectiveness, and lifetime healthcare costs of EVO as compared to DPP. Exploratory analyses will examine maintenance, moderators, and mediators of the treatment effect. STUDY

designThe EVO trial will recruit nationally to randomize 524 participants with obesity. Participants will receive either EVO or DPP over a 6 month period. EVO participants will be provided online lessons, a smartphone application to self-monitor diet, physical activity, and weight, and attend 12 brief calls with a Health Promotionist. DPP participants will receive the first 6 months of the Center for Disease Control's T2D materials and attend 16 one-hour video call sessions with staff certified in DPP delivery. Weight will be measured at baseline, 3-, 6-, and 12-months. Itemized delivery cost will be collected. Staff and participants will also provide information to estimate costs for intervention-related activities. SIGNIFICANCE: The EVO trial could establish evidence supporting dissemination of a scalable, cost-effective behavioral treatment with potential to shift clinical practice guidelines, inform policy, and reduce the prevalence of obesity.

Indexed as

Mobile ApplicationsWeight LossBehavior TherapyDietEquivalence Trials as TopicHumansObesityRandomized Controlled Trials as TopicEconomic evaluationmHealthObesityOptimizationTelehealthWeight loss

Identifiers

PMID35378301
PMCPMC9133162

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.