TY - JOUR
AU - El Zein
AU - K. M. Ellison
AU - J. G. Clina
AU - C. Reynolds
AU - C. W. Cohen
AU - J. O. Hill
AU - G. R. Dutton
AU - T. S. Mehta
AU - R. D. Sayer
A1 - 
AB - BACKGROUND: Intervention 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. METHODS: Forty 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. RESULTS: Findings 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. CONCLUSIONS: This 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 REGISTRATION: NCT04392283 on April 19th, 2020.
AD - Department of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.; Division of Physical Activity and Weight Management, Department of Internal Medicine, Medical Center, University of Kansas, Kansas City, KS, 66160, USA.; Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.; Department of General Internal Medicine and Population Science, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.; Department of Family and Community Medicine, University of Alabama at Birmingham, Birmingham, AL, 35233, USA. sayerd@uab.edu.
AN - 40188105
BT - Pilot Feasibility Stud
C5 - General Literature
CP - 1
DA - Apr 5
DO - 10.1186/s40814-025-01618-4
DP - NLM
ET - 20250405
IS - 1
JF - Pilot Feasibility Stud
LA - eng
N2 - BACKGROUND: Intervention 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. METHODS: Forty 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. RESULTS: Findings 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. CONCLUSIONS: This 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 REGISTRATION: NCT04392283 on April 19th, 2020.
PY - 2025
SN - 2055-5784 (Print); 2055-5784
SP - 40
ST - A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity
T1 - A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity
T2 - Pilot Feasibility Stud
TI - A pilot sequential multiple assignment randomized trial for developing a biobehavioral adaptive intervention to improve insulin sensitivity in patients with stage 1 obesity
U1 - General Literature
U3 - 10.1186/s40814-025-01618-4
VL - 11
VO - 2055-5784 (Print); 2055-5784
Y1 - 2025
ER -