Decreasing cardiometabolic risk in survivors of childhood cancer: survivors engaged in time-restricted eating after therapy (STRENGTH)

Active Project Grant Awarded Last action

Award ID
R01CA286563
Recipient
Awarding agency
Obligated
$2,270,534

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date 44% complete
Place of performance
New York, NY 10065, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Over 500,000 survivors of childhood cancer are living in the united states today. Cardiovascular disease is the leading cause of noncancer late mortality in this cohort. Subgroups of survivors, including individuals previously exposed to radiation to the chest, abdomen, and total body, are also at treatment-related risk for a constellation of cardiometabolic comorbidities, including type 2 diabetes mellitus, chronic inflammation, and hypertension, which further amplifies their risk of cardiovascular disease. Tailored, scalable and sustainable interventions that target modifiable risk factors, such as obesity, are thus urgently needed to reduce cardiometabolic risk in this cohort. Time-restricted eating, or voluntary abstinence from all caloric intake for 14- 16 hours per day, has been demonstrated in pre-clinical and human studies to combat these risks. This mode of fasting appears to be feasible, safe, and sustainable in diverse populations. Results on the efficacy of time- restricted eating, however, are discrepant across studies, with some studies demonstrating marked improvement in weight, glycemic control, and circadian rhythm alignment and others showing minimal effect. Yet this intervention has not been tested in childhood cancer survivors, and IT is unknown whether IT would be an efficacious risk-reducing intervention in this population. The proposed strength (survivors engaged in time-restricted eating after therapy) study would fill this GAP by determining the efficacy of time-restricted eating to reduce weight and improve markers of cardiometabolic risk in radiation-exposed survivors with overweight/obesity. To this end, we will conduct a phase IIB randomized controlled trial of 300 radiation- exposed survivors of childhood cancer with overweight/obesity and enrolled in the childhood cancer survivor study (CCSS). Participants will be randomized to either a 6-month time-restricted eating intervention followed by a 6-month maintenance phase, or usual care, which consists of mailed educational handouts on healthy lifestyle behaviors. We will: (1) determine the impact of time-restricted eating on measures of weight status and other weight-related outcomes (waist circumference, percent body FAT); (2) assess the impact of time- restricted eating on cardiometabolic risk profile (blood pressure, glycemic control, insulin resistance, adipokines, markers of inflammation); (3) identify moderating and mediating factors, as well as barriers and facilitators, associated with adherence to the intervention and weight loss, with the goal of informing future implementation efforts. The proposed time-restricted eating intervention, which is grounded in social cognitive theory, will include stepwise progression to build self-efficacy using "nudges" and motivational interviewing. This proposal will leverage novel mhealth technology to deliver a fully remote, theoretically grounded behavioral intervention to reduce cardiometabolic risk and thereby address the burdens of cancer and its treatment among adult-aged survivors of childhood cancer. Time-restricted eating may represent a sustainable intervention to improve long-term outcomes in a highly morbid survivor cohort.

Transactions

Action Obligated Date
Amendment $731,806
Amendment $744,198
Amendment $0
Original award $794,530

Subawards

Subrecipient Amount Awarded
Research Foundation Of The City University Of New York Dr. Jennifer Ford will primarily be involved in Aim 3 of this grant, which proposes to assess mediators and moderators of adherence and weight loss among… $33,384
The Trustees Of The University Of Pennsylvania The following is a statement of work describing Dr. Kelly Allison’s role on the project entitled “Decreasing Cardiometabolic Risk in Survivors of Childhood… $33,182
ST Jude Children's Research Hospital Inc. Dr. Greg Armstrong will provide guidance in the use of the CCSS resource by fielding queries on all aspects related to use of the cohort who are overweight or… $120,651
Fred Hutchinson Cancer Center Dr. Eric Chow will serve as a co-investigator on this proposal, including continuing his role as a mentor for the Dr. Friedman. This includes meeting with her… $79,690

Quick answers

Who received award R01CA286563?

R01CA286563 was awarded to Sloan-Kettering Institute For Cancer Research by National Cancer Institute (National Institutes of Health) on September 1, 2024.

How much is award R01CA286563 worth?

$2,270,534 has been obligated on R01CA286563.

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