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Behavioural Intervention

Experimental: Intervention Group for Sedentary Lifestyle (HEART Trial)

N/A

Recruiting

Research Sponsored by Tufts University

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 9 months

Awards & highlights

HEART Trial Summary

This trial aims to assess the effects of a health and wellness program with behavior change guides on Head Start educators in the greater Boston area. The study will involve surveys and analysis of data collected through a health

Who is the study for?

This trial is for Head Start educators in the greater Boston area who are looking to improve their health and wellness. Participants should be interested in enhancing their eating habits, physical activity levels, and sleep hygiene through a new program.Check my eligibility

What is being tested?

The study tests a health and wellness program combined with behavior change guides at ABCD Head Start Centers. It involves surveys on diet, exercise, sleep, app satisfaction, plus analysis of app usage data to evaluate the program's impact.See study design

What are the potential side effects?

Since this is not a drug trial but an educational intervention focusing on lifestyle changes, there aren't typical medical side effects. However, participants may experience changes in routine or temporary discomfort adjusting to new habits.

HEART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Engagement with Guide

Nutrition behaviors

Physical activity behaviors

+2 more

Secondary outcome measures

BMI

Blood glucose

Blood pressure

+2 more

HEART Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: Intervention GroupExperimental Treatment1 Intervention

Behavioral: Access to health and wellness App from baseline to nine months. Access to Guides from baseline to six months

Group II: Delayed InterventionActive Control1 Intervention

Behavioral: No access to health and wellness App from baseline to six months Access to App and Guide from six to nine months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental

2008

Completed Phase 2

~2200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of Agriculture (USDA)FED

97 Previous Clinical Trials

350,562 Total Patients Enrolled

Tufts UniversityLead Sponsor

266 Previous Clinical Trials

661,923 Total Patients Enrolled

2 Trials studying Sedentary Lifestyle

376 Patients Enrolled for Sedentary Lifestyle

National Head Start AssociationUNKNOWN

Frequently Asked Questions

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

Is the enrollment for this study currently open?

"Affirmative, details on clinicaltrials.gov imply that this study is currently enrolling volunteers. Initially shared on December 14th, 2023, and most recently revised on March 28th, 2024, the research aims to recruit a total of 200 participants from one designated site."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Affirmative. Information retrieved from clinicaltrials.gov indicates that patient recruitment is ongoing for this research initiative. The trial was initially listed on December 14, 2023 and received its most recent update on March 28, 2024. A total of 200 participants are sought from a single designated location."

Answered by AI

What are the anticipated results that this research aims to achieve?

"The primary focus of this study, which will span approximately 9 months, is to assess nutrition behaviors. Secondary aims involve monitoring blood glucose levels through non-fasting finger prick tests, tracking BMI values derived from measured height and weight data, as well as recording systolic and diastolic blood pressure readings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial)

2023. "HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06346574.

All > Paid Studies Boston