# SMARTer weight loss management

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2023 · $690,407

## Abstract

Project Summary
This application proposes to compare an optimized, resource-efficient, adaptive obesity treatment against a
gold-standard fixed treatment package and assessment only control. The obesity pandemic continues
unabated, presaging an onslaught of diabetes. Despite numerous initiatives, gold standard Diabetes
Prevention Program (DPP) intensive multicomponent behavioral treatment for overweight and obesity remains
too expensive, burdensome, and difficult to scale to suggest that it can be provided to the 2/3 of the population
that needs to lose weight. To address this challenge, we strive to optimize less burdensome treatment
approaches that can maximize weight loss in the population that has obesity with reduced resource
expenditure. In the SMART Weight Loss Management trial, we randomly assigned 400 adults with
overweight/obesity to a stepped care weight loss intervention in which first line treatment was either 1) a
smartphone app alone (App) or 2) the app plus coaching (App + C). Participants who did not attain adequate
weight loss (i.e., averaging >0.5 lb/week) were classified as nonresponders, and re-randomized to be stepped
up by a modest or vigorous addition of treatment components. Preliminary Results showed that: 1) More
patients achieved clinically meaningful 6 month weight loss with App + C than App; 2) App + C non-responders
who adhered to the vigorous step-up (text message and meal replacement) lost as much weight as responders
by 12-months. These compelling findings point to a need to test the efficacy of SMARTER stepped-care
intervention in a randomized controlled trial. The SMARTer trial is a three-arm, non-inferiority randomized
controlled trial that compares the optimized, adaptive SMARTer intervention against gold-standard DPP and
Control. The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard
DPP by achieving comparable weight loss at less cost. If so, we will emerge with a scalable, effective
intervention that tailors to patient response using a stepped-care model. Alongside evaluation of clinical non-
inferiority, a comprehensive economic analysis will inform relative affordability and scalability. Hypotheses are
that: 1) SMARTer stepped-care will be non-inferior to gold standard DPP in its effect on 6 month weight loss;
and 2) The SMARTer intervention will be more cost-effective to implement. We will explore whether extending
the SMARTer intervention results in weight loss maintenance at 12 months compared to DPP and Control.
Lastly, we will explore mediators and moderators of SMARTer's effect on weight loss to inform future
intervention optimization. If successful, findings will support dissemination of a cost-effective obesity population
management strategy that facilitates treating obesity with the resources it needs – not more, and not less.

## Key facts

- **NIH application ID:** 10567424
- **Project number:** 1R01DK134629-01
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Angela Fidler Pfammatter
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $690,407
- **Award type:** 1
- **Project period:** 2023-07-01 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10567424

## Citation

> US National Institutes of Health, RePORTER application 10567424, SMARTer weight loss management (1R01DK134629-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10567424. Licensed CC0.

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