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NIH grant 1R01DK144066-01A1: An efficient factorial design to optimize behavioral changes and improve health outcomes in adults prescribed next-generation obesity medications
Institute: {'code': 'DK', 'abbreviation': 'NIDDK', 'name': 'National Institute of Diabetes and Digestive and Kidney Diseases', 'admin_org_id': '12500020', 'admin_funding_url': ''}. PI: Rebecca A. Krukowski. Award: $744590.
Start: 2026-08-21T00:00:00.
PROJECT SUMMARY
A new generation of anti-obesity medications (AOMs) have recently revolutionized the treatment of obesity.
Critically, and in line with existing clinical guidelines for AOM use, clinical trials have evaluated these
medications as an “adjunct to lifestyle intervention”; that is, all participants (whether randomized to placebo or
study medication) received lifestyle intervention. There exists discordance, however, between the way that
AOMs have been implemented in clinical trials (with lifestyle intervention) versus how they are implemented in
clinical settings (with minimal follow-up focused on management of dosage and side effects). Furthermore,
there is lack of clarity regarding whether patients prescribed second-generation AOMs benefit from behavioral
lifestyle intervention and, if so, how much and what kind of lifestyle intervention is optimally beneficial. To
address these critical questions, we propose to conduct a factorial experiment to optimize an individual-level
lifestyle intervention for patients prescribed second-generation AOMs. We propose to recruit 608 adults with
obesity (or overweight with a weight-related comorbidity) who are prescribed second-generation AOMs by their
healthcare providers and, using an efficient 2x2x2x2x2 factorial trial design, randomize participants to receive
(or not receive) each of 5 intervention components delivered over 12 months: 1) an individual Weight Loss 101
session including core weight loss education and behavioral skills training; 2) 3 individual coaching sessions
delivered via telephone; 3) digital dietary self-monitoring and weekly automated feedback on calorie goal
achievement; 4) digital physical activity self-monitoring and weekly automated feedback on activity goal
achievement; and 5) digital weight self-monitoring and weekly automated feedback on weight trajectory. We
propose to evaluate the efficacy of each intervention component for weight loss and identify an optimized
program in which each component (or combination of components) contributes meaningfully to Month 12
weight loss outcomes (Aim 1). Importantly, we will also examine costs for each intervention component to
inform future implementation. Under a precision medicine approach, we also propose to explore possible
moderators (e.g., sex, race/ethnicity, age, income, nutrition literacy, rurality, level of social support, previous
experience with lifestyle intervention, AOM type/dose and number of AOMs used) that might suggest different
intervention protocols for specific subgroups. In addition, given the challenge of long-term weight loss
maintenance, we also propose to examine weight loss maintenance at Month 24 (Aim 2). Other exploratory
aims will investigate changes in body composition, health-related quality of life, hypothesized mediators such
as treatment adherence, and additional health outcomes extracted from electronic health records; finally, we
will explore AOM persistence and weight regain in participants who discontinue AOMs. This trial will result in an
optimized behavioral intervention protocol for second-generation AOMs, supporting ideal implementation of
these medications and development of new guidelines for the treatment of obesity.document fetched 2026-08-30 02:46