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Completed

NCT Number: NCT05817838

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

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.

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Key information

Conditions

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Adults:

  • 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
  • read/speak English, Hmong, Khmer, Vietnamese and/or Lao
  • own a smartphone
  • be willing to shop at the partner SEA grocery store

Exclusion criteria

for Adults:

  • 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)

Inclusion criteria

for Children:

  • Hmong, Cambodian, Laotian or Vietnamese
  • age 6 to 11 years
  • read/speak English
  • Veggie Meter score ≤400

Exclusion criteria

for Children:

  • disabilities that would affect participation
  • chronic conditions affecting growth or diet
  • medications affecting weight or metabolism

Treatment and study plan

Financial Incentives

Behavioral

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 Multicomponent

Behavioral

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 Engagement

Other

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.

Primary outcomes

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

    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

Secondary outcomes

  1. Diet quality as Assessed by 24-Hour Dietary Recall - Child

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

    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.

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

    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.

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

    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.

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

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

    Time frame: Study enrollment to six-month follow-up

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

  12. HbA1c - adult and child

    Time frame: Study enrollment to six-month follow-up

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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Center for Southeast Asians
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • University of Connecticut

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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