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Diet, HealthyNCT05817838

Using Family-Based Approaches to Improve Healthy Eating for Southeast Asian Children

A study testing Financial Incentives, Financial Incentives and Multilevel Multicomponent and School Engagement in people with Diet, Healthy, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This small scale healthy eating study provides Southeast Asian families with children ages 6 to 11 with a family-based nutrition education, one-on-one interviews to help with motivation to eat health, text messaging, and coupons to purchase health foods and beverages. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Diet, Healthy
What is being tested?
Financial Incentives, Financial Incentives and Multilevel Multicomponent and School Engagement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteUnited States
Study dates
12 Apr 2023to 18 Jun 2025
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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Hmong, Cambodian, Laotian or Vietnamese
  • the child's parent, legal guardian or grandparent
  • live with the child
  • age 18 or older
  • knowledgeable about the child's diet
  • responsible for household food preparation
Show all 13Show fewer
  • read/speak English, Hmong, Khmer, Vietnamese and/or Lao
  • own a smartphone
  • be willing to shop at the partner SEA grocery store
  • Hmong, Cambodian, Laotian or Vietnamese
  • age 6 to 11 years
  • read/speak English
  • Veggie Meter score ≤400

Who cannot join

  • participation in weight-related studies in the past 12 months
  • medical conditions that would affect participation (e.g., hospitalization due to type 2 diabetes in past year)
  • disabilities that would affect participation
  • chronic conditions affecting growth or diet
  • medications affecting weight or metabolism

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Brown University

    Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: Testing a Multilevel, Multicomponent, Multigenerational Dietary Intervention to Improve Southeast Asian Children's Diets

This small scale healthy eating study provides Southeast Asian families with children ages 6 to 11 with a family-based nutrition education, one-on-one interviews to help with motivation to eat health, text messaging, and coupons to purchase health foods and beverages. Since this is a small scale study that is a pilot intervention, the main goal of this intervention is to determine if it is feasible, meaning, can it be done. The second goal of this intervention is to determine if there are meaningful improvements in children's healthy eating patterns, body mass index and HbA1c. The third goal is to see if the intervention improves parent's diet quality, HbA1c and the home food environment. These study findings will be used to determine whether a larger clinical trial is needed, and if so, how it should be done.

Read the detailed description

This intervention reflects the investigative team's eight year and ongoing academic-community research partnership with the Center for Southeast Asians (SEA) in Rhode Island, formative work with SEA families, and the team's extensive experience conducting successful dietary interventions. The current study is a pilot feasibility study that tests an innovative multilevel, multicomponent, multigenerational dietary intervention to improve diet quality among SEA children.

75 SEA families with children ages 6 to 11 years will be recruited from Providence County, Rhode Island. Adult-child pairs will be randomized to: (1) financial incentive only arm that will receive weekly $15 financial incentive coupons to subsidize purchase of healthy foods at a local SEA grocery store; or (2) financial incentive plus twice-monthly, family-based group nutrition education at the Center for SEA led by SEA community health workers; three motivational interviewing (MI) calls by trained community health workers; dietary norms messaging for adults (via weekly text messages) and for children (via Infographics at nutrition education sessions); and weekly $15 financial incentive coupons to subsidize purchase of healthy foods at SEA grocery stores; or (3) an Academic Engagement attention control arm that will follow the structure of the financial incentive plus nutrition education, MI and text messages and infographics arm. The primary outcomes are study feasibility and clinically meaningful improvement in child's diet quality (measured by healthy eating index). Secondary outcomes are clinically meaningful changes in children's body mass (~ 2kg weight loss or no weight gain), HbA1c (0.5%) and parent's diet quality, HbA1c and the home food environment. These study findings will be used to inform a future, larger clinical trial.

Conditions
Diet, Healthy
Being tested
Financial Incentives, Financial Incentives and Multilevel Multicomponent, School Engagement
Keywords
Asian Americans, Cambodian Americans, Hmong Americans, Vietnamese Americans, Laotian Americans, child, parents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial IncentivesBehavioural

    For six months, families will receive weekly, $15 financial incentives to purchase healthy foods and beverages at a partnering Southeast Asian grocery store

  • Financial Incentives and Multilevel MulticomponentBehavioural

    For six months, families will receive weekly, $15 financial incentives to purchase healthy foods and beverages at a partnering Southeast Asian grocer store, in-person, group-based nutrition education with other Southeast Asian families, text messages and motivational interviewing

  • School EngagementOther

    For six months, families will attend in-person, group-based school engagement education with other Southeast Asian families designed to improve youths' academic outcomes. Families will receive text messages and motivational interviews. At the end of the six months, families will receive the equivalent of the six months worth of weekly, $15 financial incentives.

Study groups in NCT05817838
Study groupRoleWhat they receive
Attention control: Academic EngagementOtherThis intervention will be delivered using a similar format and schedule as the financial incentive+nutrition education, motivational interviewing and dietary norms intervention group (i.e., 11 community health worker led in-person group based sessions at the Center for Southeast Asians, 3 MI phone calls, and text messages). The content will focus on family-specific family engagement methods to improve children's academic outcomes.
Receives: Other: School Engagement
Financial incentive onlyExperimentalParticipants will receive weekly financial incentive coupons to purchase eligible foods at the partnering Southeast Asian grocery store. Research Assistants will explain the coupon procedures during the randomization phone call. Research Assistants will mail the adult a schedule of coupon disbursement dates. RAs will mail one month's worth of coupons (4, $15 coupons) to each adult's home. Coupons will be used at point-of-sale. Participants' will receive an automated weekly text message via Qualtrics directing them to upload their photos to the system if they used coupons during that week.
Receives: Behavioral: Financial Incentives
Financial incentive + nutrition education, motivational interviewing, dietary norms messagesExperimentalThe intervention consists of a) four $15 financial incentive coupons each month; b) twice-monthly group-based nutrition education at the Center for SEA; c) motivational interviewing (months 1, 3, 5); and d) weekly dietary norms text messages sent to adults and twice-monthly dietary norms infographics presented at nutrition education sessions for children. The research assistants will disburse one months' worth of the financial incentive coupon at the nutrition education sessions (or home mailings for absent participants). Families will attend 11 fortnightly, group-based nutrition education sessions lasting one hour. Southeast Asian community health workers will lead the sessions. Research assistants trained in motivational interviewing will call the adults. The calls will last 15-20 minutes. Adults will receive a series of weekly, interactive descriptive dietary norms text messages. Children will see descriptive dietary norms infographics at children's nutrition education sessions.
Receives: Behavioral: Financial Incentives and Multilevel Multicomponent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Study Methods As Assessed by Rate of Participant Enrollment Each Month

    Feasibility will be demonstrated if 7 enrolled Southeast Asian families per month are recruited on average over 12 months

    Measured: Study enrollment to six-month follow-up

  2. Feasibility of Study Methods As Assessed by Participant Retention at 6-Months Study Completion

    Feasibility will be demonstrated if 80% of enrolled families are retained at 6 months

    Measured: Study enrollment to six-month follow-up

  3. Feasibility of Study Methods As Assessed by Participant Attendance at Group Sessions at 6-Months Study Completion

    Feasibility will be demonstrated if 0% of enrolled families attend in-person sessions

    Measured: Study enrollment to six-month follow-up

  4. Acceptability of the Intervention As Assessed by Participant Favorability Rating of the Intervention at Six-Months

    Acceptability for each intervention component will be achieved if at least 70% of participants rate the component as "favorable" or "very favorable" on the measure of acceptability

    Measured: Study enrollment to six-month follow-up

Secondary outcomes (12)
  1. Diet quality as Assessed by 24-Hour Dietary Recall - Child

    24-Hour dietary recall data will be converted to Healthy Eating Index scores to provide overall and subcomponent scores.

    Measured: Study enrollment to six-month follow-up

  2. Fruit and vegetable intake as Assessed by The Veggie Meter - Child

    Children's fruit and vegetable intake will be determined using the Veggie Meter, which is an objective measure of dermal carotenoids over a two month period.

    Measured: Study enrollment to six-month follow-up

  3. Height ( Meters) as Assessed by Portable Stadiometer - Child and Adult

    Objectively assessed height will be measured by research assistants using a portable stadiometer.

    Measured: Study enrollment to six-month follow-up

  4. Weight (Kilograms) as Assessed by Tanita Body Scale - Child and Adult

    Objectively assessed weight will be measured by research assistants using the Tanita Body Weight Scale.

    Measured: Study enrollment to six-month follow-up

  5. Body Mass Index (BMI) as Assessed by the Ratio of Height/Weight (kg/m^2) - Child and Adult

    Weight and height measures will be combined to compute Body Mass Index. Body Mass Index will be determined using appropriate child and adult reference values, respectively.

    Measured: Study enrollment to six-month follow-up

  6. Waist Circumference (Inches) as Assessed by Seca Flexible Tape Measure - Child and Adult

    Objectively assessed waist circumference will be measured by research assistants. Waist circumference categories will be determined using appropriate child and adult reference values, respectively.

    Measured: Study enrollment to six-month follow-up

  7. Height (Feet and Inches) as Assessed by Portable Stadiometer - Child and Adult

    Objectively assessed height, weight and waist circumference will be measured by research assistants. Body Mass Index and waist circumference categories will be determined using appropriate child and adult reference values, respectively.

    Measured: Study enrollment to six-month follow-up

  8. Beverage Intake as Assessed by the Beverage Intake Questionnaire (Ounces) - Adult

    Adult participants will complete a brief questionnaire to measure beverage intake (BEVQ-15).

    Measured: Study enrollment to six-month follow-up

  9. Food Behaviors as Assessed by the Townsend Food Behaviors Checklist (units on a scale) - Adult

    Adult participants will complete the Townsend Food Behaviors Checklist regarding consumption of foods and healthy food-related behaviors.

    Measured: Study enrollment to six-month follow-up

  10. Fruit and Vegetable Intake as Assessed by The Veggie Meter Score

    A Veggie Meter score (objective measure of fruit and vegetable intake) will be obtained for adults.

    Measured: Study enrollment to six-month follow-up

  11. Home Food Environment as Assessed by a Food Inventory Checklist (units on a scale)

    Adults will complete a self-report survey of the home food environment using the 23-item Home Food Inventory checklist.

    Measured: Study enrollment to six-month follow-up

  12. HbA1c - adult and child

    Child and adult HbA1c trained research staff will conduct finger sticks using established protocols (detailed protocol in Protection of Human Subjects)

    Measured: Study enrollment to six-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start12 Apr 2023
  3. Primary completion12 Jan 2025
  4. Study completion18 Jun 2025

Resources

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
Model description
Adult-child pairs will be randomized to: (1) financial incentive only arm that will receive weekly $15 financial incentive coupons to subsidize purchase of healthy foods at a local SEA grocery store; or (2) financial incentive plus twice-monthly, family-based group nutrition education at the Center for SEA led by SEA community health workers; three motivational interviewing (MI) calls by trained community health workers; dietary norms messaging for adults (via weekly text messages) and for children (via Infographics at nutrition education sessions); and weekly $15 financial incentive coupons to subsidize purchase of healthy foods at SEA grocery stores; or (3) an Academic Engagement attention control arm that will follow the structure of the financial incentive plus nutrition education, MI and text messages and infographics arm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05817838
Sponsor's protocol ID
2022003499
Other IDs
1R01DK128197-01A1
Status last verified
May 2026
First submitted
21 Mar 2023
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be made available to outside individuals because the data obtained from this feasibility R01 will be used to inform a larger, fully-powered R01-equivalent clinical trial.

Publications

  • Dulin A, Tovar A, Dunsiger S, Carey KB, Gans KM. Protocol for the Southeast Asian Healthy Habits, Healthy Kids (SEAHK) study, a culturally tailored family-based pilot randomized controlled trial to improve dietary quality. Pilot Feasibility Stud. 2026 Jun 11. doi: 10.1186/s40814-026-01863-1. Online ahead of print.

    PubMed 42277916

Questions about this trial

What is this clinical trial studying?

A study testing Financial Incentives, Financial Incentives and Multilevel Multicomponent and School Engagement in people with Diet, Healthy, run by Brown 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 13 inclusion and 5 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 18 May 2026. 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?

Feasibility of Study Methods As Assessed by Rate of Participant Enrollment Each Month (time frame: Study enrollment to six-month follow-up). The study lists 4 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 NCT05817838, which also lists 1 linked publication.

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 18 May 2026.

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