Clinical trial NCT06346574: HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Physical Inactivity
Sleep Hygiene
Keywords: Health and Wellness app
Head Start educators
Guided goal setting
Motivational Interviewing for behavior change
Workplace wellness
Dietary habits
Physical inactivity
Sleep hygiene
Early Childhood Educators
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: National Head Start Association
First posted: 2024-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be educators at Head Start centers where either the intervention is offered at the onset of the study (intervention group) or after six months (comparison condition).
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of health and wellness App
timeFrame: 9-months
measure: Engagement with Guide
timeFrame: 9-months
measure: Nutrition behaviors
timeFrame: 9 months
measure: Physical activity behaviors
timeFrame: 9 months
measure: Sleep habits
timeFrame: 9 months
Secondary outcomes:
measure: BMI
timeFrame: 9 months
measure: Cholesterol
timeFrame: 9 months
measure: Triglycerides
timeFrame: 9 months
measure: Blood pressure
timeFrame: 9 months
measure: Blood glucose
timeFrame: 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References: