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

NCT06346574 | Completed

• 1 other identifier: STUDY-0004282
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• BMI

  9 months

• Cholesterol

  9 months

• Triglycerides

  9 months

• Blood pressure

  9 months

• Blood glucose

  9 months

Study Arms (2)

Experimental: Intervention Group

EXPERIMENTAL

Behavioral: 1. Access to health and wellness App from baseline to nine months. 2. Access to Guides from baseline to six months

Behavioral: Experimental

Delayed Intervention

ACTIVE COMPARATOR

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

Behavioral: Experimental

Interventions

Experimental BEHAVIORAL

Participants will receive access to health and wellness app and guide

Delayed Intervention; Experimental: Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tufts University: lead
• United States Department of Agriculture (USDA): collaborator
• National Head Start Association: collaborator

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Feeding Behavior; Sedentary Behavior; Sleep Hygiene

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 4, 2024
• Study Start: December 14, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)