protocolSection identificationModule nctId: NCT06346574, orgStudyIdInfo id: STUDY-0004282, briefTitle: HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial), acronym: HEART, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-14, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: United States Department of Agriculture (USDA), collaborators name: National Head Start Association, descriptionModule briefSummary: 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., conditionsModule conditions: Dietary Habits, conditions: Physical Inactivity, conditions: Sleep Hygiene, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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)., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Experimental, outcomesModule primaryOutcomes measure: Use of health and wellness App, primaryOutcomes measure: Engagement with Guide, primaryOutcomes measure: Nutrition behaviors, primaryOutcomes measure: Physical activity behaviors, primaryOutcomes measure: Sleep habits, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood glucose, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts University, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Katrina Sarson, MS, MEd, role: CONTACT, phone: 617-636-3737, email: katrina.sarson@tufts.edu, contacts name: Sujata Dixit-Joshi, MPH, PhD, role: CONTACT, phone: 617-636-3737, email: sujata.dixit_joshi@tufts.edu, contacts name: Christina Economos, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False