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

Physical Inactivity Clinical Trial

— HEART  

Official title:

Changing the Culture of Health: Creating and Testing an Evidence-based Wellness Program for Diverse Head Start Centers, ABCD Head Start Randomized Control Trial: Healthy Eating, Activity, Relaxation Trial (HEART) at Head Start Pilot.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06346574
• Other study ID #: STUDY-0004282
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Health and Wellness Apps can reduce barriers and increase access to health information. Supplemental coaching and support to set goals and work towards them may increase the likelihood of achieving physical activity and nutrition goals. This model of access to an App with supplemental support can be applied to improve the health and wellness of Head Start educators.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Educator at ABCD Head Start Center in the Greater Boston area

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.

Exclusion Criteria: None

Related Conditions & MeSH terms

• Dietary Habits
• Physical Inactivity
• Sleep Hygiene

Intervention

Behavioral:
• Experimental
Participants will receive access to health and wellness app and guide

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	National Head Start Association, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of health and wellness App	App based tracker use data	9-months
Primary	Engagement with Guide	Number of guide sessions attended	9-months
Primary	Nutrition behaviors	Self-reported food intake	9 months
Primary	Physical activity behaviors	Self-reported physical activity	9 months
Primary	Sleep habits	Self-reported sleep habits	9 months
Secondary	BMI	BMI values calculated using measured height and weight	9 months
Secondary	Cholesterol	Non-fasting blood cholesterol obtained through finger prick method	9 months
Secondary	Triglycerides	Non-fasting blood triglyceride obtained through finger prick method	9 months
Secondary	Blood pressure	Measured systolic and diastolic blood pressure	9 months
Secondary	Blood glucose	Non-fasting blood glucose obtained through finger prick method	9 months