Trials / Recruiting
RecruitingNCT05817838
Using Family-Based Approaches to Improve Healthy Eating for Southeast Asian Children
Testing a Multilevel, Multicomponent, Multigenerational Dietary Intervention to Improve Southeast Asian Children's Diets
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Brown University · Academic / Other
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Timeline
- Start date
- 2023-05-12
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2023-04-18
- Last updated
- 2025-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05817838. Inclusion in this directory is not an endorsement.