ObesityNCT03601299
Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
A study testing Traditional food in people with Obesity, run by Alaska Native Tribal Health Consortium at 1 site in United States.
Trial summary
Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Traditional food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 31 Jul 2023
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- for the Focus Group Discussions: Consenting Alaska Native residents of the 12 communities involved in the study, aged 18 and over.
- for the intervention study: Upon parental or guardian consent, Alaska Native residents of the 12 communities involved in the study, aged 0-5 years and enrolled in the RurAL CAP Head start, Early Head start, or Parents as Teachers, programs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
About this study
Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). This 5-year intervention trial targeting 0-5 year olds is conducted in partnership with Rural Community Action Program, Inc. (RCAP) Head Start (HS), Early Head Start (EHS), and Parents as Teachers (PAT) programs in 12 rural Alaskan communities in the Yukon-Kuskokwim (YK) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually.
This intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease SSB consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by RCAP to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. Fish/Farm-to- Schools) to increase integration of traditional foods into the diet.
Read more
Phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in Phase 2.
Phase 1 includes:
- Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
- Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
- Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities.
- Work to expand the "Fish to Schools" and "Farm to Preschool" programs into YK RCAP HS programs.
Phase 2 includes implementing:
- A physical activity curriculum in HS programs in all communities
- A traditional food in HS menu program in intervention communities
- A home-based nutrition program in intervention communities
- A mechanism to document traditional foods important to each community
- Conditions
- Obesity
- Being tested
- Traditional food
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional foodOther
Increasing traditional food consumption through Head start programs in Alaska
| Study group | Role | What they receive |
|---|---|---|
| Traditional food arm | Experimental | Traditional food-focused menu Receives: Other: Traditional food |
| Non-intervention arm | No intervention | Standard RurAL CAP menu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Change in Proportion of AN children 3-5 years old with a BMI greater than or equal to the 95th percentile
Measured: Measured annually over 4 years of intervention
Traditional food content
Change in Percentage of total calories derived from traditional foods
Measured: Measured annually over 4 years of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start14 May 2018
- Primary completion30 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaska Native Tribal Health Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Rural Alaska Community Action Program, Inc. (RurAL CAP), University of Alaska Fairbanks, University of Alaska Anchorage, Yukon Kuskokwim Health Corporation
- Responsible party
- Sponsor
- Investigators
- Timothy K Thomas, MD, Principal investigator, Alaska Native Tribal Health ConsortiumKathy Koller, PhD, Study director, Alaska Native Tribal Health Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601299
- Sponsor's protocol ID
- 5RO1NRO15417-02
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2018
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ohle KA, Koller KR, Walch AK, Lee FR, Palmer L, Nu J, Thomas TK. Alaska Native Parents' Decision-Making About Food, Beverages, and Screen Time for Young Children: Formative Insights From the "Got Neqpiaq?" Project. Fam Community Health. 2023 Oct-Dec 01;46(4):250-258. doi: 10.1097/FCH.0000000000000370.
PubMed 37703513Hill CM, Paschall MJ, Koller KR, Day GM, Lee FR, O'Brien DM, King DK, Palmer L, Thomas TK, Bersamin A. Obesity Prevalence and Dietary Factors Among Preschool-Aged Head Start Children in Remote Alaska Native Communities: Baseline Data from the "Got Neqpiaq?" Study. Child Obes. 2023 Oct;19(7):498-506. doi: 10.1089/chi.2022.0143. Epub 2022 Dec 5.
PubMed 36473164Koller KR, Flanagan CA, Nu J, Lee FR, Desnoyers C, Walch A, Alexie L, Bersamin A, Thomas TK. Storekeeper perspectives on improving dietary intake in 12 rural remote western Alaska communities: the "Got Neqpiaq?" project. Int J Circumpolar Health. 2021 Jan 1;80(1):1961393. doi: 10.1080/22423982.2021.1961393.
PubMed 34350814
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska
- ClinicalTrials.gov ID
- NCT03601299
- Acronym / sponsor ID
- 5RO1NRO15417-02
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Alaska Native Tribal Health ConsortiumUniversity, hospital or other
- Collaborators
- Rural Alaska Community Action Program, Inc. (RurAL CAP), University of Alaska Fairbanks, University of Alaska Anchorage, Yukon Kuskokwim Health Corporation
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Jul 2018 (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.
Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). This 5-year intervention trial targeting 0-5 year olds is conducted in partnership with Rural Community Action Program, Inc. (RCAP) Head Start (HS), Early Head Start (EHS), and Parents as Teachers (PAT) programs in 12 rural Alaskan communities in the Yukon-Kuskokwim (YK) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually.
This intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease SSB consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by RCAP to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. Fish/Farm-to- Schools) to increase integration of traditional foods into the diet.
Phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in Phase 2.
Phase 1 includes:
- Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
- Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
- Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities.
- Work to expand the "Fish to Schools" and "Farm to Preschool" programs into YK RCAP HS programs.
Phase 2 includes implementing:
- A physical activity curriculum in HS programs in all communities
- A traditional food in HS menu program in intervention communities
- A home-based nutrition program in intervention communities
- A mechanism to document traditional foods important to each community
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional food arm | Experimental | Other: Traditional foodTraditional food-focused menu |
| Non-intervention arm | No intervention | –Standard RurAL CAP menu |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- for the Focus Group Discussions: Consenting Alaska Native residents of the 12 communities involved in the study, aged 18 and over.
- for the intervention study: Upon parental or guardian consent, Alaska Native residents of the 12 communities involved in the study, aged 0-5 years and enrolled in the RurAL CAP Head start, Early Head start, or Parents as Teachers, programs
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Traditional foodIncreasing traditional food consumption through Head start programs in Alaska | Other | Traditional food arm |
Primary outcome
Body Mass Index (BMI)
Time frame: Measured annually over 4 years of intervention
Change in Proportion of AN children 3-5 years old with a BMI greater than or equal to the 95th percentile
Traditional food content
Time frame: Measured annually over 4 years of intervention
Change in Percentage of total calories derived from traditional foods
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 31 Jul 2024.
- Derived from this study: PubMed 37703513Ohle KA, Koller KR, Walch AK, Lee FR, Palmer L, Nu J, Thomas TK. Alaska Native Parents' Decision-Making About Food, Beverages, and Screen Time for Young Children: Formative Insights From the "Got Neqpiaq?" Project. Fam Community Health. 2023 Oct-Dec 01;46(4):250-258. doi: 10.1097/FCH.0000000000000370.
- Derived from this study: PubMed 36473164Hill CM, Paschall MJ, Koller KR, Day GM, Lee FR, O'Brien DM, King DK, Palmer L, Thomas TK, Bersamin A. Obesity Prevalence and Dietary Factors Among Preschool-Aged Head Start Children in Remote Alaska Native Communities: Baseline Data from the "Got Neqpiaq?" Study. Child Obes. 2023 Oct;19(7):498-506. doi: 10.1089/chi.2022.0143. Epub 2022 Dec 5.
- Derived from this study: PubMed 34350814Koller KR, Flanagan CA, Nu J, Lee FR, Desnoyers C, Walch A, Alexie L, Bersamin A, Thomas TK. Storekeeper perspectives on improving dietary intake in 12 rural remote western Alaska communities: the "Got Neqpiaq?" project. Int J Circumpolar Health. 2021 Jan 1;80(1):1961393. doi: 10.1080/22423982.2021.1961393.
- Individual participant dataSharing planned: Undecided
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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.
Timothy K Thomas, MD principal investigator
Alaska Native Tribal Health Consortium
Kathy Koller, PhD study director
Alaska Native Tribal Health Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional food in people with 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 2 inclusion and 1 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 31 Jul 2024. 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?
Body Mass Index (BMI) (time frame: Measured annually over 4 years of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601299, which also lists 3 linked publications.
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 31 Jul 2024.