Child ObesityMOYDNCT06303544
More Outside Your Door: a Diet/physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers
A study testing Wedge 1 in people with Child Obesity, run by Alaska Native Tribal Health Consortium at 1 site in United States.
Trial summary
The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity
- What is being tested?
- Wedge 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent who identifies as Alaska Native (AN)
- parental consent
- enrolled in preschool in one of the12 participating Head Start programs
- present at school for health screenings
Who cannot join
- lack of parental consent
- does not have a parent who is AN
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
Barb Stillwater, PhD, 907 729 3644
About this study
Official title: More Outside Your Door (MOYD): a Multilevel Intervention Promoting Traditional Diet and Physical Activity to Decrease Risk of Obesity in Alaska Native (AN) Preschoolers
The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.
Read the detailed description
The Rural Alaska Community Action Program (RurAL CAP), which administers Head Start schools in rural Alaska, reports that 68% of Alaska Native children ages 3 to 5 years are overweight and 43% are obese. Diet, physical activity, and sleep hygiene are primary risk factors for childhood obesity, a risk factor for cardiometabolic diseases later in life. Notably, subclinical cardiovascular pathology can be detected as early as 3 years of age. Once living off the land and sea, Alaska Native (AN) people have suffered decades of colonization and in-migration, which have interfered with traditional food consumption, signaling a striking change in local food systems. Diet and physical activity are prime targets for early intervention, as taste preferences and exercise habits established in childhood forge lifelong adherence. Thus, investigators have designed More Outside Your Door, a multilevel intervention, which at the individual level builds on prior efforts to promote traditional diet and activities to decrease risk for obesity in Alaska Native preschoolers. At the family level, MOYD provides feedback to parents about their child's health screenings; at the school level, it features traditional foods, outdoor traditional physical activities, and a culturally centered curriculum. At the community level, it offers resources to improve the built environment for safe outdoor play that invites all community members to participate. In partnership, the Alaska Native Tribal Health Consortium, RurAL CAP, and collaborators will refine and test the effectiveness of MOYD at 12 Head Start preschools in the Yukon-Kuskokwim region: (1) investigators will use qualitative methods with Head Start staff, parents, and community Elders to optimally tailor MOYD for southwest Alaska communities; (2) investigators will conduct a stepped-wedge group-randomized trial to test its effect on children's diet, physical activity (PA), body mass index (BMI), and other risk factors for obesity-related chronic disease over three years. Primary outcomes are diet (classroom meals, actigraphy-based physical activity, and body mass index. Secondary outcomes include individual child level measures of hemoglobin levels and educational and developmental progress; parent report of diet, activity, and sleep at home; and measures of traditional foods/sugar-sweetened/processed foods by carbon and nitrogen stable isotope ratios using fingernail clippings. Investigators will also measure outcomes at the school level (classroom meals, outdoor time) and community level (objective data on use of play space). (3) Investigators will conduct a process evaluation using the RE-AIM framework. The Specific Aims are to (1) conduct preschool staff and parent/elder workgroups to refine the MOYD intervention for optimal effectiveness for obesity prevention among AN preschool children; (2) test the effectiveness of MOYD on a) diet, PA, outdoor time, and BMI; and b) improving other clinical and behavioral risk factors for obesity-related chronic disease in preschool children; and (3) Implement the RE-AIM framework to evaluate dissemination and implementation of the MOYD intervention in Head Start programs.
- Conditions
- Child Obesity
- Being tested
- Wedge 1
- Keywords
- Head Start, CBPR
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge 1Behavioural
Wedge1 will receive intervention consisting of culturally based physical activity module, built environment, community healthy lifestyle promotion
| Study group | Role | What they receive |
|---|---|---|
| Wedge 1 | Experimental | Four villages of 12 will be randomized into Wedge 1. Four of the remaining 8 villages will be randomized to Wedge 2. The remaining 4 villages will be Wedge 3. Receives: Behavioral: Wedge 1 |
| Wedge 2 | No intervention | While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls. |
| Wedge 3 | No intervention | While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body mass index (kg/m2)
Measured: 3 years
Physical activity
Measured via accelerometers (minutes)
Measured: 3 years
Outdoor time
Time (minutes) spent outdoors by children
Measured: 3 years
Sleep quality
Hours of sleep measured by survey
Measured: 3 years
Fingernail nitrogen & carbon stable isotope ratios
Measurements of traditional food intake and added sugar intake
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies 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
- Sequential
- Model description
- Wedge design using repeated cross sectional samples of Head Start preschool students
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaska Native Tribal Health Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, University of Alaska Anchorage
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303544
- Sponsor's protocol ID
- R01HL168853
- Acronym
- MOYD
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any shared data will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Outside Your Door (MOYD): a Multilevel Intervention Promoting Traditional Diet and Physical Activity to Decrease Risk of Obesity in Alaska Native (AN) Preschoolers
- ClinicalTrials.gov ID
- NCT06303544
- Acronym / sponsor ID
- MOYD / R01HL168853
- Conditions
- Child Obesity
- Keywords
- Head Start, CBPR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Alaska Native Tribal Health ConsortiumUniversity, hospital or other
- Collaborators
- Washington State University, University of Alaska Anchorage
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 12 Mar 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.
The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.
Detailed description
The Rural Alaska Community Action Program (RurAL CAP), which administers Head Start schools in rural Alaska, reports that 68% of Alaska Native children ages 3 to 5 years are overweight and 43% are obese. Diet, physical activity, and sleep hygiene are primary risk factors for childhood obesity, a risk factor for cardiometabolic diseases later in life. Notably, subclinical cardiovascular pathology can be detected as early as 3 years of age. Once living off the land and sea, Alaska Native (AN) people have suffered decades of colonization and in-migration, which have interfered with traditional food consumption, signaling a striking change in local food systems. Diet and physical activity are prime targets for early intervention, as taste preferences and exercise habits established in childhood forge lifelong adherence. Thus, investigators have designed More Outside Your Door, a multilevel intervention, which at the individual level builds on prior efforts to promote traditional diet and activities to decrease risk for obesity in Alaska Native preschoolers. At the family level, MOYD provides feedback to parents about their child's health screenings; at the school level, it features traditional foods, outdoor traditional physical activities, and a culturally centered curriculum. At the community level, it offers resources to improve the built environment for safe outdoor play that invites all community members to participate. In partnership, the Alaska Native Tribal Health Consortium, RurAL CAP, and collaborators will refine and test the effectiveness of MOYD at 12 Head Start preschools in the Yukon-Kuskokwim region: (1) investigators will use qualitative methods with Head Start staff, parents, and community Elders to optimally tailor MOYD for southwest Alaska communities; (2) investigators will conduct a stepped-wedge group-randomized trial to test its effect on children's diet, physical activity (PA), body mass index (BMI), and other risk factors for obesity-related chronic disease over three years. Primary outcomes are diet (classroom meals, actigraphy-based physical activity, and body mass index. Secondary outcomes include individual child level measures of hemoglobin levels and educational and developmental progress; parent report of diet, activity, and sleep at home; and measures of traditional foods/sugar-sweetened/processed foods by carbon and nitrogen stable isotope ratios using fingernail clippings. Investigators will also measure outcomes at the school level (classroom meals, outdoor time) and community level (objective data on use of play space). (3) Investigators will conduct a process evaluation using the RE-AIM framework. The Specific Aims are to (1) conduct preschool staff and parent/elder workgroups to refine the MOYD intervention for optimal effectiveness for obesity prevention among AN preschool children; (2) test the effectiveness of MOYD on a) diet, PA, outdoor time, and BMI; and b) improving other clinical and behavioral risk factors for obesity-related chronic disease in preschool children; and (3) Implement the RE-AIM framework to evaluate dissemination and implementation of the MOYD intervention in Head Start programs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Wedge design using repeated cross sectional samples of Head Start preschool students
| Arm | Type | Receives |
|---|---|---|
| Wedge 1 | Experimental | Behavioral: Wedge 1Four villages of 12 will be randomized into Wedge 1. Four of the remaining 8 villages will be randomized to Wedge 2. The remaining 4 villages will be Wedge 3. |
| Wedge 2 | No intervention | –While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls. |
| Wedge 3 | No intervention | –While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- parent who identifies as Alaska Native (AN)
- parental consent
- enrolled in preschool in one of the12 participating Head Start programs
- present at school for health screenings
Key exclusion criteria (2 listed)
- lack of parental consent
- does not have a parent who is AN
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 |
|---|---|---|
| Wedge 1Wedge1 will receive intervention consisting of culturally based physical activity module, built environment, community healthy lifestyle promotion | Behavioural | Wedge 1 |
Primary outcome
BMI
Time frame: 3 years
Body mass index (kg/m2)
Physical activity
Time frame: 3 years
Measured via accelerometers (minutes)
Outdoor time
Time frame: 3 years
Time (minutes) spent outdoors by children
Sleep quality
Time frame: 3 years
Hours of sleep measured by survey
Fingernail nitrogen & carbon stable isotope ratios
Time frame: 3 years
Measurements of traditional food intake and added sugar intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No. Any shared data will be deidentified.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wedge 1 in people with Child Obesity, run by Alaska Native Tribal Health Consortium 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barb Stillwater (907-729-3644, bjstillwater@anthc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 3 years). 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 29 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.