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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05817838
• Other study ID #: 2022003499
• Secondary ID: 1R01DK128197-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2023
• Source: Brown University
• Contact: Akilah Dulin, PhD
• Phone: 401-863-5392
• Email: akilah_dulin[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Behavioral:
• 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
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Brown University	Center for Southeast Asians, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	Height ( Meters) as Assessed by Portable Stadiometer - Child and Adult	Objectively assessed height will be measured by research assistants using a portable stadiometer.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	Beverage Intake as Assessed by the Beverage Intake Questionnaire (Ounces) - Adult	Adult participants will complete a brief questionnaire to measure beverage intake (BEVQ-15).	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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.	Study enrollment to six-month follow-up
Secondary	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)	Study enrollment to six-month follow-up