CompletedNot Applicable

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

United States48 participantsStarted 2023-12-14

Plain-language summary

With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Educator at ABCD Head Start Center in the Greater Boston area
. Ability to speak, read, and write in English fluently
. Ability to download and use the Health and Wellness App on their mobile phone or computer
. Residing in the US at the time of enrollment
. Able to attend the baseline health fair at a ABCD Head Start Center

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Use of health and wellness App

Timeframe: 9-months

Engagement with Guide

Timeframe: 9-months

Nutrition behaviors

Timeframe: 9 months

Physical activity behaviors

Timeframe: 9 months

Sleep habits

Timeframe: 9 months

Trial details

NCT IDNCT06346574

SponsorTufts University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Dietary Habits trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Educator at ABCD Head Start Center in the Greater Boston area
. Ability to speak, read, and write in English fluently
. Ability to download and use the Health and Wellness App on their mobile phone or computer
. Residing in the US at the time of enrollment
. Able to attend the baseline health fair at a ABCD Head Start Center