Testing a Multilevel, Multicomponent, Multigenerational Dietary Intervention to Improve Southeast Asian Children's Diets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Feasibility of Study Methods As Assessed by Rate of Participant Enrollment Each Month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Attention control: Academic Engagement
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.
干预措施: School Engagement (Other)
Financial incentive only
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.
干预措施: Financial Incentives (Behavioral)
Financial incentive + nutrition education, motivational interviewing, dietary norms messages
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.
干预措施: Financial Incentives and Multilevel Multicomponent (Behavioral)
结局指标
主要结局
Feasibility of Study Methods As Assessed by Rate of Participant Enrollment Each Month
时间窗: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 7 enrolled Southeast Asian families per month are recruited on average over 12 months
Feasibility of Study Methods As Assessed by Participant Retention at 6-Months Study Completion
时间窗: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 80% of enrolled families are retained at 6 months
Feasibility of Study Methods As Assessed by Participant Attendance at Group Sessions at 6-Months Study Completion
时间窗: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 0% of enrolled families attend in-person sessions
Acceptability of the Intervention As Assessed by Participant Favorability Rating of the Intervention at Six-Months
时间窗: Study enrollment to six-month follow-up
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
次要结局
- 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)
- Waist Circumference (Inches) as Assessed by Seca Flexible Tape Measure - Child and Adult(Study enrollment to six-month follow-up)
- Height (Feet and Inches) as Assessed by Portable Stadiometer - Child and Adult(Study enrollment to six-month follow-up)
- Beverage Intake as Assessed by the Beverage Intake Questionnaire (Ounces) - Adult(Study enrollment to six-month follow-up)
- Food Behaviors as Assessed by the Townsend Food Behaviors Checklist (units on a scale) - Adult(Study enrollment to six-month follow-up)
- Fruit and Vegetable Intake as Assessed by The Veggie Meter Score(Study enrollment to six-month follow-up)
- Home Food Environment as Assessed by a Food Inventory Checklist (units on a scale)(Study enrollment to six-month follow-up)
- HbA1c - adult and child(Study enrollment to six-month follow-up)