Eating Better Together: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Project Reach, total number of participants/patients who meet eligibility criteria
研究概览
简要总结
Eating Better Together is a 6-month pilot program that teaches families about healthy eating and activity and provides home deliveries of fresh fruits and vegetables from a local retail partner.
详细描述
Efficacious primary care-based childhood overweight/obesity interventions for children from low-income homes are needed to address health disparities. The University of Tennessee (UT) and Cherokee Health Systems (CHS), a federally qualified health center, has piloted a 6-month childhood overweight/obesity intervention for underserved children (R34DK109504). The intervention was based upon Prevention Plus, the recommended primary care-based treatment for childhood overweight/obesity, which includes targeting fruit and vegetable (FV) and sugar-sweetened beverage intake, physical activity, and screen time; incorporates behavior modification techniques, and uses a family-based approach. The intervention structure was designed to reduce family costs related to time, thus monthly contact alternated between in-person sessions and phone calls, and in-person sessions could occur using "warm hand-offs" between providers (allowed piggybacking of appointments). The pilot demonstrated CHS' ability to implement the intervention using their electronic health record (EHR). The intervention significantly reduced child standardized BMI (ZBMI).
While the intervention reduced ZBMI, the degree of reduction was below what is recommended to achieve cardiometabolic improvements in children (-0.25 ZBMI). Families (58.9% with a household income of < $20,000/yr, 32.9% with household food insecurity, 50.7% receiving SNAP benefits, and 94.5% receiving free or reduced-price school meals) reported problems with having enough food, particularly FVs, which was a barrier for intervention participation. Thus, increasing the affordability of FVs may enhance the achievement of intervention dietary goals, which should increase diet quality and enhance ZBMI reduction.
One method to increase FV affordability is a prescription incentive program. In these programs, a "prescription," often for FVs, from a health care provider is given to the participant, and the prescription includes delivery of fresh FVs to the family's home. Adult FV prescription studies have reported increases in FV intake and decreases in BMI. In children, three uncontrolled studies reported that an FV prescription program increased FV intake, with the influence on child weight status not reported. Thus, to enhance the efficacy of our 6-month Prevention Plus intervention in addressing health disparities in childhood overweight/obesity, investigators will pilot test Prevention Plus, our tested intervention, with the addition of an FV prescription incentive program (Prevention Plus+FVx). For Prevention Plus+FVx, to assist families in achieving FV goals (FV prescription), they will receive up to $60/month ($1/day for each child and parent) deliveries of fresh FVs to their home from a local retail partner (Food City). Thirty families receiving their primary care from CHS, with an adult caregiver and a child aged 4 to 10 years with a BMI > 85th percentile, will participate in the program.
Participants
CHS families eligible for the trial will be patients at the CHS Knox County Pediatric Clinic. Additional eligibility criteria include families with a child who is aged 4 to 10 years, with a BMI > 85 percentile, who have an adult (> 18 years) caregiver living in the household willing to participate in the program. The adult caregiver needs to be able to read and speak English; and be willing to shop for fresh fruits and vegetables at the Western Ave Food City store (1950 Western Ave., Knoxville, TN, 37921).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at the Cherokee Health Systems clinic in Cherokee Mills
- •Child age between 4 to 10 years old
- •Child BMI > 85th percentile
- •Child must have an adult caregiver (> 18 years) living in the household and be willing to participate in the program
- •Adult caregivers need to be able to read and speak English
排除标准
- •Not patients at the CHS Knox County Pediatric Clinic
- •A child not within the 4 to 10 years age range
- •Child BMI at or below the 85 percentile
- •Child without an adult caregiver (> 18 years) living in the household and not willing to participate in the program
- •Adult caregivers that are not able to read and speak English
研究组 & 干预措施
Prevention Plus
Child's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverages (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks < 100% juice, and punches) servings /wk, ≥1 1/2 cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to < 2 hours/day. The caregiver's energy balance behavioral goals will be to consume < 3 sugar-sweetened beverage servings/wk, ≥ 2 1/2 cups/day of whole vegetables and ≥ 1 1/2 cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week and reduce TV viewing to < 10 hours/wk.
干预措施: Prevention Plus (Behavioral)
结局指标
主要结局
Project Reach, total number of participants/patients who meet eligibility criteria
时间窗: through study completion, an average of 6 months
Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the total number of participants/patients who meet the eligibility criteria for the study.
Project Reach, participants who are eligible to participate in this study, but decline to participate in the study
时间窗: through study completion, an average of 6 months
Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who are eligible to participate in this study, but decline to participate in the study.
Project Reach, the number of participants who participate in the study
时间窗: through study completion, an average of 6 months
Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who participate in the study.
Intervention Session Completion
时间窗: through study completion, an average of 6 months
Completion of the number of each intervention session will be documented in the EHR.
Funds spent on FV deliveries
时间窗: through study completion, an average of 6 months
Looking at total amount spent of FV deliveries will help us to identify if the fruit and vegetable prescription program was implemented as intended.
次要结局
- Household Information(Change from baseline and through study completion, an average of 6 months)
- Food Purchasing and Household Food Availability(Change from baseline and through study completion, an average of 6 months)
- Food Security(Change from baseline and through study completion, an average of 6 months)
- Dietary Intake of Fruits and Vegetables(Change from baseline and through study completion, an average of 6 months)
- Beverage Intake(Change from baseline and through study completion, an average of 6 months)
- Demographics(Baseline only)
- Anthropometrics(Change from baseline and through study completion, an average of 6 months)
研究者
Hollie Raynor
Associate Dean of Research for the College of Education, Health, and Human Sciences
The University of Tennessee, Knoxville
