Evidence map›Paper›PMID 40188105›Full record

ArticlePilot and feasibility studies2025

A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity.

Aseel El Zein, Katie M Ellison, Julianne G Clina, Chelsi Reynolds, Caroline W Cohen, James O Hill, Gareth R Dutton, Tapan S Mehta, R Drew Sayer

Registry-linked trialAbstract read
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In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04392283, which is not on this map. Cited by 1 paper.

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

What it found

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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.

NCT04392283 no registry record found
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

9 authors.

Aseel El ZeinDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Katie M EllisonDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Julianne G ClinaDivision of Physical Activity and Weight Management, Department of Internal Medicine, Medical Center, University of Kansas, Kansas City, KS, 66160, USA.
Chelsi ReynoldsDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Caroline W CohenDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
James O HillDepartment of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Gareth R DuttonDepartment of General Internal Medicine and Population Science, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Tapan S MehtaDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
R Drew SayerDepartment of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA. sayerd@uab.edu.ORCID http://orcid.org/0000-0002-9488-7030

Funding

Why is the prevalence of obesity so high in U.S. Southern States? Regional predictors of BMI and obesity treatment response.P30DK056336 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BARBARA A GOWER · 2000 to 2026
$31.9M
NIDDK NIH HHS P30 DK056336
6 · The paper itself

Abstract

backgroundIntervention packages targeting obesity-related conditions often include multiple behavioral and pharmacological components, yet the independent and synergistic effects of these strategies on disease progression remain largely unexplored. Adaptive interventions offer a structured approach to tailoring treatments based on individual responses, but feasibility data in primary care settings are limited. The objective of this pilot Sequential Multiple Assignment Randomized Trial (SMART) was to investigate the feasibility of a 25-week adaptive biobehavioral intervention designed to improve insulin sensitivity among patients with stage 1 obesity.

methodsForty participants were initially randomized to either nutrition counseling (NC) or exercise counseling (EC), both employing a weight-neutral approach. At week 8, insulin sensitivity was reassessed using the Quantitative Insulin Sensitivity Check Index (QUICKI). Participants with a > 5% improvement were classified as responders, while non-responders were re-randomized to either augment their first-stage intervention with metformin or switch to weight loss counseling (WLC). Feasibility outcomes included recruitment and retention, adherence to intervention components, and preliminary treatment effect estimates.

resultsFindings support the overall feasibility of the SMART design, with high adherence to virtual counseling sessions and favorable participant retention. The study effectively differentiated responders from non-responders at week 8, with responders showing greater improvements in insulin sensitivity. Among non-responders, WLC and metformin provided a potential rescue effect, but overall insulin sensitivity remained lower than at of responders. While NC and WLC were preferred over EC and metformin, adherence to counseling sessions remained high across all interventions, regardless of preference. Metformin adherence posed challenges due to frequent gastrointestinal side effects and difficulties tracking usage.

conclusionsThis pilot study supports the feasibility of an adaptive biobehavioral intervention for improving insulin sensitivity among adults with obesity in a primary care setting. However, further refinement is needed to enhance clinical integration, optimize intervention messaging, and improve medication tracking. Findings from this study will inform a second pilot SMART, laying the foundation for a full-scale primary-care embedded intervention delivering personalized, adaptive strategies for improving cardiometabolic health.

trial registrationNCT04392283 on April 19th, 2020.

Indexed as

Adaptive interventionBiobehavioral interventionCardiometabolic HealthExercise counselingInsulin sensitivityMetforminNutrition counselingObesityPersonalized treatmentPrimary careSequential Multiple Assignment Randomized Trial (SMART)

Identifiers

PMID40188105
PMCPMC11971893

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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.