Dietary HabitsHEARTNCT06346574
HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial)
A study testing Experimental in people with Dietary Habits and Physical Inactivity, run by Tufts University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Physical Inactivity, Sleep Hygiene
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Dietary Habits, Physical Inactivity, Sleep Hygiene
- Being tested
- Experimental
- 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
- Medical subject headings
- Feeding Behavior, Sedentary Behavior, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Participants will receive access to health and wellness app and guide
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of health and wellness App
App based tracker use data
Measured: 9-months
Engagement with Guide
Number of guide sessions attended
Measured: 9-months
Nutrition behaviors
Self-reported food intake
Measured: 9 months
Physical activity behaviors
Self-reported physical activity
Measured: 9 months
Sleep habits
Self-reported sleep habits
Measured: 9 months
Secondary outcomes (5)
BMI
BMI values calculated using measured height and weight
Measured: 9 months
Cholesterol
Non-fasting blood cholesterol obtained through finger prick method
Measured: 9 months
Triglycerides
Non-fasting blood triglyceride obtained through finger prick method
Measured: 9 months
Blood pressure
Measured systolic and diastolic blood pressure
Measured: 9 months
Blood glucose
Non-fasting blood glucose obtained through finger prick method
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start14 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), National Head Start Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346574
- Sponsor's protocol ID
- STUDY-0004282
- Acronym
- HEART
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06346574
- Acronym / sponsor ID
- HEART / STUDY-0004282
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), National Head Start Association
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: ExperimentalBehavioral: 1. Access to health and wellness App from baseline to nine months. 2. Access to Guides from baseline to six months |
| Delayed Intervention | Active comparator | Behavioral: ExperimentalBehavioral: 1. No access to health and wellness App from baseline to six months 2. Access to App and Guide from six to nine months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalParticipants will receive access to health and wellness app and guide | Behavioural | Delayed Intervention, Experimental: Intervention Group |
Primary outcome
Use of health and wellness App
Time frame: 9-months
App based tracker use data
Engagement with Guide
Time frame: 9-months
Number of guide sessions attended
Nutrition behaviors
Time frame: 9 months
Self-reported food intake
Physical activity behaviors
Time frame: 9 months
Self-reported physical activity
Sleep habits
Time frame: 9 months
Self-reported sleep habits
5 secondary outcomes
BMI
Time frame: 9 months
Cholesterol
Time frame: 9 months
Triglycerides
Time frame: 9 months
Blood pressure
Time frame: 9 months
Blood glucose
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Dietary Habits and Physical Inactivity, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of health and wellness App (time frame: 9-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.