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

NCT ID: NCT05817838

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2025-09-30

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Attention control: Academic Engagement

This 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.

Group Type: OTHER

School Engagement

Intervention Type: 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.

Financial incentive only

Participants 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.

Group Type: EXPERIMENTAL

Financial Incentives

Intervention Type: 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 incentive + nutrition education, motivational interviewing, dietary norms messages

The 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.

Group Type: EXPERIMENTAL

Financial Incentives and Multilevel Multicomponent

Intervention Type: 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

Interventions

Financial Incentives

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

Intervention Type: BEHAVIORAL

Financial Incentives and Multilevel Multicomponent

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

Intervention Type: BEHAVIORAL

School Engagement

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

Center for Southeast Asians

UNKNOWN

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akilah Dulin, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Kim Gans, PhD, MPH, LDN

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

Brown University

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Akilah Dulin, PhD

Role: CONTACT

akilah_dulin@brown.edu

401-863-5392

Facility Contacts

Akilah Dulin, PhD

Role: primary

akilah_dulin@brown.edu

Other Identifiers

1R01DK128197-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022003499

Identifier Type: -

Identifier Source: org_study_id