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

Brown University

Status: Enrolling

Conditions: Diet, Healthy

Treatments: Behavioral: Financial Incentives; Other: School Engagement; Behavioral: Financial Incentives and Multilevel Multicomponent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05817838

1R01DK128197-01A1 (U.S. NIH Grant/Contract)

2022003499

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Attention control: Academic Engagement

Other group

Description:

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.

Treatment:

Other: School Engagement

Financial incentive only

Experimental group

Description:

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.

Treatment:

Behavioral: Financial Incentives

Financial incentive + nutrition education, motivational interviewing, dietary norms messages

Experimental group

Description:

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.

Treatment:

Behavioral: Financial Incentives and Multilevel Multicomponent