HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial)
NCT ID: NCT06346574
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2023-12-14
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data.
A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Researching Emotions And Cardiac Health: Phase III
NCT03220204
Feasibility and Implementation of a Healthy Lifestyles Program
NCT03258138
Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
NCT04207268
Behavioral Mechanisms and Health Outcomes of Positive Psychological Intervention
NCT06483568
Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs
NCT05535348
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Head Start is the largest federally funded early childhood education program which provides an array of services to families in an early childhood care setting. The impact of Head Start on school readiness and nutritional outcomes of families has been examined extensively. There is growing awareness of the importance of supporting Head Start educators with their own health and wellness needs. There is a large volume of research that supports the use of Health and Wellness Apps.
The USDA awarded Tufts University a grant to develop, test, and evaluate an innovative health and wellness program for Head Start educators. Tufts University selected ABCD Head Start, which includes 19 Centers and approximately 250 educators in the greater Boston area. The team at Tufts University is leading the implementation and evaluation of the intervention, in collaboration with the National Head Start Association (NHSA) with ABCD Head Start as a community partner.
HEART at Head Start aims to generate evidence to inform how an innovative program can support the health and wellbeing of Head Start educators at the intervention centers compared to those at delayed intervention centers. Study participants will be provided access to the health and wellness app, which can either be downloaded onto mobile phones or accessed via the web. Users will be able to use a variety of health and wellness resources, webinars, as specialized coaching through this app. Additionally, Tufts guides will work closely with study participants to facilitate individual goal setting and to support work towards these set goals.
Evaluation findings will inform stakeholders about the feasibility of using a Health and Wellness App in conjunction with a guide to support Head Start educators with their health and wellness goals.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Intervention Group
Behavioral:
1. Access to health and wellness App from baseline to nine months.
2. Access to Guides from baseline to six months
Experimental
Participants will receive access to health and wellness app and guide
Delayed Intervention
Behavioral:
1. No access to health and wellness App from baseline to six months
2. Access to App and Guide from six to nine months
Experimental
Participants will receive access to health and wellness app and guide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Experimental
Participants will receive access to health and wellness app and guide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ability to speak, read, and write in English fluently
3. Ability to download and use the Health and Wellness App on their mobile phone or computer
4. Residing in the US at the time of enrollment
5. Able to attend the baseline health fair at a ABCD Head Start Center
Study participants will be educators at ABCD Head Start centers where either the Health and Wellness App is offered at the onset of the study (intervention) or six months after the onset of the study (delayed intervention.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Agriculture (USDA)
FED
National Head Start Association
UNKNOWN
Tufts University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tufts University
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY-0004282
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.