Lifestyle intervention for sustained remission of metabolic syndrome
Abstract Body (Do not enter title and authors here): Hypotheses Metabolic syndrome (MetS) affects 42% of U.S. adults and has fundamental etiology in lifestyle. Interventions to optimize lifestyle are effective, but sustainability after treatment is a challenge. The hypothesis was that for patients with MetS, a 6-month habit-based lifestyle program would be superior to ongoing education on sustaining MetS remission through 24 months.
Design Single-blind, individually randomized, partially clustered trial of 618 participants with MetS recruited between 2019-2022 from 5 U.S. locations and followed for 24 months.
Methods. Recruitment used a combination of electronic medical records and social media advertisements. Exclusions were based upon medical safety, logistical or behavioral barriers, or confounding treatments. Participants were randomized to Treatment (N=306) or Comparator (N=312). The primary outcome was MetS remission at 24 months. Secondary outcomes at 6 and 24 months included MetS components, weight, and lifestyle. Analyses were intent-to-treat using mixed models adjusted for prespecified covariates.
Treatments All participants received an activity monitor. Those randomized to Treatment underwent a 6-month, small group treatment aimed at developing the habit of eating vegetables at meals and daily brisk walks, supported by the mindfulness habits of sensory awareness and emotion regulation. After 6 months, there was no further treatment, but 18 monthly support contacts were offered. Those randomized to Comparator received monthly AHA education tip sheets over 24 months
Results. Of 14,817 screened, 618 were randomized into arms that were comparable at baseline. The cohort was 24% male, 26% non-white, 41% Conclusions. This trial demonstrates that sustained MetS remission can be achieved after treatment ends and that a group treatment to develop simple healthy lifestyle habits was more effective than standard education.
Powell, Lynda
( RUSH UNIV MED CTR
, Chicago
, Illinois
, United States
)
Zimmermann, Laura
( RUSH UNIV MED CTR
, Chicago
, Illinois
, United States
)
Suzuki, Sumihiro
( RUSH UNIV MED CTR
, Chicago
, Illinois
, United States
)
Berkley-patton, Jannette
( University of Missouri-Kansas City
, Kansas City
, Missouri
, United States
)
Drees, Betty
( University of Missouri-Kansas City
, Kansas City
, Missouri
, United States
)
Karavolos, Kelly
( Rush University Medical Center
, Chicago
, Illinois
, United States
)
Lohse, Barbara
( Rochester Institute of Technology
, Rochester
, New York
, United States
)
Masters, Kevin
( University of Colorado Denver
, Denver
, Colorado
, United States
)
Nicklas, Jacinda
( University of Colorado Denver
, Denver
, Colorado
, United States
)
Rothschild, Steven K.
( RUSH UNIV MED CTR
, Chicago
, Illinois
, United States
)
Yeh, Chen
( RUSH UNIV MED CTR
, Chicago
, Illinois
, United States
)
Author Disclosures:
Lynda Powell:DO NOT have relevant financial relationships
| Laura Zimmermann:No Answer
| Sumihiro Suzuki:No Answer
| Jannette Berkley-Patton:No Answer
| Betty Drees:DO have relevant financial relationships
;
Research Funding (PI or named investigator):Viridian Therapeutics:Active (exists now)
; Research Funding (PI or named investigator):Tourmaline Bio, Inc. :Active (exists now)
; Research Funding (PI or named investigator):Acelyrin, Inc:Active (exists now)
| Kelly Karavolos:DO NOT have relevant financial relationships
| Barbara Lohse:DO have relevant financial relationships
;
Advisor:Ellyn Satter Institute:Active (exists now)
| Kevin Masters:No Answer
| Jacinda Nicklas:No Answer
| Steven K. Rothschild:No Answer
| Chen Yeh:DO NOT have relevant financial relationships