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

NCT05817838 | Recruiting

• 2 other identifiers: 20220034991R01DK128197-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy

Keywords

Asian Americans; Cambodian Americans; Hmong Americans; Vietnamese Americans; Laotian Americans; child; parents

Outcome Measures

Primary Outcomes (4)

• 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

  Study enrollment to six-month follow-up

• 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

  Study enrollment to six-month follow-up

• 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

  Study enrollment to six-month follow-up

• 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

  Study enrollment to six-month follow-up

Secondary Outcomes (12)

• Diet quality as Assessed by 24-Hour Dietary Recall - Child

  Study enrollment to six-month follow-up

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

  Study enrollment to six-month follow-up

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

  Study enrollment to six-month follow-up

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

  Study enrollment to six-month follow-up

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

  Study enrollment to six-month follow-up

Study Arms (3)

Attention control: Academic Engagement

OTHER

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.

Other: School Engagement

Financial incentive only

EXPERIMENTAL

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.

Behavioral: Financial Incentives

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

EXPERIMENTAL

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.

Behavioral: Financial Incentives and Multilevel Multicomponent

Interventions

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 incentive only

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

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

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.

Attention control: Academic Engagement

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Hmong, Cambodian, Laotian or Vietnamese
• age 6 to 11 years
• read/speak English
• Veggie Meter score ≤400
• disabilities that would affect participation
• chronic conditions affecting growth or diet
• medications affecting weight or metabolism

Sponsors & Collaborators

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

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

Study Officials

• Akilah Dulin, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Kim Gans, PhD, MPH, LDN

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akilah Dulin, PhD

CONTACT

401-863-5392; akilah_dulin@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: May 12, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)