Culturally-Adapted Diet for Puerto Rican Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in levels of adipose risk factor
研究概览
简要总结
This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.
详细描述
This pilot intervention will culturally-tailor a diet to the Puerto Rican adult population based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk factors of type 2 diabetes and obesity. Based on preliminary results from studies in the island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be unaware of the which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-65 y old at the time of enrollment
- •Non-institutionalized
- •Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 6 months
- •Able to answer questions without assistance
- •Having a cellphone with the capacity to receive text messages
- •Having at least two of the following:
- •elevated BMI
- •elevated waist circumference
- •self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure
- •self-reported physician-diagnosed pre-diabetes or measured pre-diabetes
- •self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia
排除标准
- •Under 25 or over 65 years of age
- •Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months
- •Institutionalized
- •Not able to answer questions without assistance
- •Not having at least 2 of the five listed metabolic criteria
- •Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.
- •Self-reported pregnancy
- •Gastrointestinal or chronic conditions
- •Food intolerance or allergies
结局指标
主要结局
Change in levels of adipose risk factor
时间窗: 4 months
Estimate the change in the value of waist circumference (cm)
Change in levels of metabolic risk factors
时间窗: 4 months
Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)
Number of dysregulated cradiometabolic risk factors
时间窗: 4 months
Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)
Change in levels of blood pressure risk factors
时间窗: 4 months
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
次要结局
- Changes in diet quality score(4 months)
- Changes in diet satisfaction: diet satisfaction scale(4 months)
研究者
Josiemer Mattei
Assistant Professor of Nutrition
Harvard School of Public Health (HSPH)