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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dietary Habits; Physical Inactivity; Sleep Hygiene
• Intervention / Treatment: Behavioral: Experimental

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University
      • Contact: Katrina Sarson, MS, MEd; Phone Number: 617-636-3737; Email: katrina.sarson@tufts.edu
      • Contact: Sujata Dixit-Joshi, MPH, PhD; Phone Number: 617-636-3737; Email: sujata.dixit_joshi@tufts.edu
      • Principal Investigator: Christina Economos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention Group; Behavioral: Access to health and wellness App from baseline to nine months.; Access to Guides from baseline to six months	Behavioral: Experimental; Participants will receive access to health and wellness app and guide
Active Comparator: Delayed Intervention; Behavioral: No access to health and wellness App from baseline to six months; Access to App and Guide from six to nine months	Behavioral: Experimental; Participants will receive access to health and wellness app and guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of health and wellness App	App based tracker use data	9-months
Engagement with Guide	Number of guide sessions attended	9-months
Nutrition behaviors	Self-reported food intake	9 months
Physical activity behaviors	Self-reported physical activity	9 months
Sleep habits	Self-reported sleep habits	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	BMI values calculated using measured height and weight	9 months
Cholesterol	Non-fasting blood cholesterol obtained through finger prick method	9 months
Triglycerides	Non-fasting blood triglyceride obtained through finger prick method	9 months
Blood pressure	Measured systolic and diastolic blood pressure	9 months
Blood glucose	Non-fasting blood glucose obtained through finger prick method	9 months

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: United States Department of Agriculture (USDA); National Head Start Association

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical inactivity; Sleep hygiene; Dietary habits; Health and Wellness app; Head Start educators; Guided goal setting; Motivational Interviewing for behavior change; Workplace wellness; Early Childhood Educators
• Other Study ID Numbers: STUDY-0004282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No