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Time-Restricted Eating and Sedentary Time Reduction for Cardiovascular Disease (IMPACT-Women Trial)

Q: What is the upper limit for the number of patients who can participate in this clinical trial?

<p>Yes, data available on clinicaltrials.gov indicates that this investigation is actively pursuing suitable candidates. The study was initially published on March 13, 2024, and underwent its most recent revision the same day. There is a requirement to recruit 65 participants from one designated site.</p>

Q: Are new patients currently being accepted for enrollment in this medical study?

<p>Indeed, information from clinicaltrials.gov shows that this trial is currently in recruitment phase. Initially uploaded on March 13th, 2024 and last modified on the same day, the study aims to enroll 65 patients at a single location.</p>

N/A

Recruiting

Led By Richard Thompson, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24-weeks, and 2 years

Awards & highlights

IMPACT-Women Trial Summary

"This trial aims to study the impact of a behavioral intervention involving supported time-restricted eating, improved diet quality, and reduced sedentary time on breast cancer patients receiving chemotherapy. The goal is to see

Who is the study for?

This trial is for women over 18 with stage I, II, or III breast cancer who are about to start chemotherapy. They must be able to perform daily activities (ECOG <3), have their oncologist's approval, speak English, and commit to the study intervention.Check my eligibility

What is being tested?

The study tests if a behavioral intervention with time-restricted eating, better diet quality, and less sitting time can reduce fat accumulation and improve heart health compared to standard care in breast cancer patients during chemotherapy.See study design

What are the potential side effects?

Potential side effects from the interventions may include hunger due to time-restricted eating patterns, changes in bowel habits from dietary adjustments, and fatigue as the body adapts to increased activity levels.

IMPACT-Women Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 24-weeks, and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24-weeks, and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24-weeks, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fat Volumes

Secondary outcome measures

Change in Framingham risk score

Change in Liver Fat Volume

Metabolic Syndrome X

+3 more

Other outcome measures

Change in Cytokines

Change in Hormonal Markers

Change in Insulin Resistance

+6 more

IMPACT-Women Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time-Restricted Eating and Sedentary Time ReductionExperimental Treatment1 Intervention

Group 1 (Experimental intervention): Participants assigned to this group will receive standard chemotherapy treatment plus a dietary program, and sedentary time reduction strategies, program and a Fitbit monitor. If you are randomized into this group, you will be asked to follow TRE, will receive nutritional education and individualized recommendations on improving diet quality and healthy eating practices, and given to strategies to work towards reducing sedentary time. These components will be gradually introduced over the 24-week program.

Group II: Nutrition and Exercise GuidelinesActive Control1 Intervention

Group 2 (Non-experimental intervention): Participants randomized to this group will receive standard chemotherapy treatment plus a single, group-based "nutrition during cancer" class, as well as a copy of Canada's Food Guide, physical activity guidelines, and a Fitbit monitor. You will be asked to only make dietary changes if they are recommended within the class or by your doctor, and to maintain your usual timing and number of meals consumed per day. Throughout the 24-week period, you will receive seven brief phone calls from a study staff member to ask about your symptoms and provide support. After the end of the study, participants in this group will be offered a one-one-one counselling session with a registered dietitian.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,112 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,449 Total Patients Enrolled

Richard Thompson, PhDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

23 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of patients who can participate in this clinical trial?

"Yes, data available on clinicaltrials.gov indicates that this investigation is actively pursuing suitable candidates. The study was initially published on March 13, 2024, and underwent its most recent revision the same day. There is a requirement to recruit 65 participants from one designated site."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Indeed, information from clinicaltrials.gov shows that this trial is currently in recruitment phase. Initially uploaded on March 13th, 2024 and last modified on the same day, the study aims to enroll 65 patients at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women

2024. "Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432856.