Clinical trial NCT05817838: Using Family-Based Approaches to Improve Healthy Eating for Southeast Asian Children
Official title: Testing a Multilevel, Multicomponent, Multigenerational Dietary Intervention to Improve Southeast Asian Children's Diets
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
Keywords: Asian Americans
Cambodian Americans
Hmong Americans
Vietnamese Americans
Laotian Americans
child
parents
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Connecticut
name: Center for Southeast Asians
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of Study Methods As Assessed by Rate of Participant Enrollment Each Month
timeFrame: Study enrollment to six-month follow-up
measure: Feasibility of Study Methods As Assessed by Participant Retention at 6-Months Study Completion
timeFrame: Study enrollment to six-month follow-up
measure: Feasibility of Study Methods As Assessed by Participant Attendance at Group Sessions at 6-Months Study Completion
timeFrame: Study enrollment to six-month follow-up
measure: Acceptability of the Intervention As Assessed by Participant Favorability Rating of the Intervention at Six-Months
timeFrame: Study enrollment to six-month follow-up
Secondary outcomes:
measure: Diet quality as Assessed by 24-Hour Dietary Recall - Child
timeFrame: Study enrollment to six-month follow-up
measure: Fruit and vegetable intake as Assessed by The Veggie Meter - Child
timeFrame: Study enrollment to six-month follow-up
measure: Height ( Meters) as Assessed by Portable Stadiometer - Child and Adult
timeFrame: Study enrollment to six-month follow-up
measure: Weight (Kilograms) as Assessed by Tanita Body Scale - Child and Adult
timeFrame: Study enrollment to six-month follow-up
measure: Body Mass Index (BMI) as Assessed by the Ratio of Height/Weight (kg/m^2) - Child and Adult
timeFrame: Study enrollment to six-month follow-up
measure: Waist Circumference (Inches) as Assessed by Seca Flexible Tape Measure - Child and Adult
timeFrame: Study enrollment to six-month follow-up
measure: Height (Feet and Inches) as Assessed by Portable Stadiometer - Child and Adult
timeFrame: Study enrollment to six-month follow-up
measure: Beverage Intake as Assessed by the Beverage Intake Questionnaire (Ounces) - Adult
timeFrame: Study enrollment to six-month follow-up
measure: Food Behaviors as Assessed by the Townsend Food Behaviors Checklist (units on a scale) - Adult
timeFrame: Study enrollment to six-month follow-up
measure: Fruit and Vegetable Intake as Assessed by The Veggie Meter Score
timeFrame: Study enrollment to six-month follow-up
measure: Home Food Environment as Assessed by a Food Inventory Checklist (units on a scale)
timeFrame: Study enrollment to six-month follow-up
measure: HbA1c - adult and child
timeFrame: Study enrollment to six-month follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Akilah Dulin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Kim Gans, PhD, MPH, LDN
role: PRINCIPAL_INVESTIGATOR
References: