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Behavioural Intervention

Wellness Program for Healthy Living (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

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.

Timeline

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

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

Find a Location

Who is running the clinical trial?

United States Department of Agriculture (USDA)FED
98 Previous Clinical Trials
285,054 Total Patients Enrolled
Tufts UniversityLead Sponsor
268 Previous Clinical Trials
596,625 Total Patients Enrolled
2 Trials studying Sedentary Lifestyle
376 Patients Enrolled for Sedentary Lifestyle
National Head Start AssociationUNKNOWN
~60 spots leftby Nov 2024