Evaluation of a Letter Intervention Among At-risk Adults Promoting a Plant-based Diet Using a Combination of Provider Testimonials, the Forks Over Knives Documentary, and Commitment- or Prevention-focused Behavioral Nudges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,234
- 试验地点
- 2
- 主要终点
- Medical Cost in US Dollars From One Year Before to One Year After Intervention
研究概览
简要总结
The researchers' mission is to promote healthier eating behavior and to reduce costs associated with healthcare. The purpose of this study is to evaluate the effects of mailing randomly selected participants a letter promoting a plant-based diet. Depending on the experimental condition, participants may additionally receive a free documentary, Forks Over Knives, and they may also get letters which use commitment- or prevention-focused messages to encourage watching the documentary and changing their eating behavior. The researchers hypothesize that receiving the documentary will be associated with lower insurance claims and improved health outcomes one and two years later. The researchers also hypothesize that using either commitment- or prevention-focused messages will also contribute to lower insurance claims and improved health outcomes compared to experimental conditions where materials did not include these messages. This study will help the researchers design evidence-supported programs that can improve people's health.
详细描述
Note that participant selection and assignment will be done at the level of the household, but analysis of outcomes will include individual-level analysis. This analytic decision was made because the researchers assume that the intervention may potentially affect other members of the household. While one person in a household will be selected for matching the eligibility criteria, the mailed materials will be addressed to all adult members of the household (defined as adults 18+ who are the spouse or child of the selected member) who are members of the Geisinger Health Plan. Outcome data will be pulled from all adult members of the household who have data through the Geisinger Health Plan.
The researchers will analyze the data using standard survey research analyses methods, including computing bivariate correlations, using general linear models, using non-parametric models for non-normally distributed insurance data, and entering variables as independent predictors in regression models to attempt to predict desired outcomes. The researchers will also use multilevel models to account for household- and individual-level data. The analysis of primary outcomes will focus on data one year after the intervention begins. Follow-up analysis on secondary outcomes will be conducted two years after the intervention begins. The researchers will conduct separate analyses of the selected participant (i.e., the individual who met the eligibility criteria) and other members of that participant's household. This will test whether there are any spillover effects of the intervention to other people in the household.
For clarity in this record, any discussion of sample size and participants refers to households, as this is the primary level for participant selection and assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers, and outcomes assessors will not know the participant's arm. Insurance claims data and medical health records will be used (after all identifying information is removed).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has two out of the three following conditions:
- •Body mass index over 30
- •Diagnosis of type 2 diabetes (specifically with at least one medication)
- •Diagnosis of cardiovascular disease
- •Has health insurance through Geisinger Health Plan (is an active member with a full 12-month enrollment in the previous year) under one of the following categories:
- •Medicare with required primary care provider
- •Individual policy under the Affordable Care Act
- •Has visited their primary care provider in the past 12 months
排除标准
- •Is institutionalized
- •Has active cancer, cirrhosis, renal failure, dementia, or active psychosis
- •Is in the same household as another selected participant
结局指标
主要结局
Medical Cost in US Dollars From One Year Before to One Year After Intervention
时间窗: 2 years
Total annual amount of medical and pharmacy costs (sum) as reported by Geisinger Health Plan. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Lower costs is the desirable outcome.
Diastolic Blood Pressure From One Year Before to One Year After Intervention
时间窗: 2 years
Taken from annual checkup with primary care provider. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Systolic blood pressure that is 80 millimeters of mercury (mmHg) or less is the desirable outcome.
Number of Visits From One Year Before to One Year After Intervention
时间窗: 2 years
Total number of primary care physician and specialist visits (sum) as reported by Geisinger Health Plan. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Fewer visits is the desirable outcome.
Number of Prescriptions From One Year Before to One Year After Intervention
时间窗: 2 years
Total number of prescriptions (fills) as reported by Geisinger Health Plan. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Fewer prescriptions is the desirable outcome.
Number of Unique Prescribed Medication From One Year Before to One Year After Intervention
时间窗: 2 years
Total number of unique prescribed medication in the past year as reported by Geisinger Health Plan. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Less unique prescribed medication is the desirable outcome.
Body Mass Index From One Year Before to One Year After Intervention
时间窗: 2 years
Taken from annual checkup with primary care provider. Computed from height (in meters) and weight (in kilograms) data with the formula kilograms/meters\^2. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. A body mass index between the range of 18.5 to 25 is the desirable outcome.
Systolic Blood Pressure From One Year Before to One Year After Intervention
时间窗: 2 years
Taken from annual checkup with primary care provider. General linear models are used to model change between the data from the year before the intervention and the data from one year after intervention. Systolic blood pressure that is 120 millimeters of mercury (mmHg) or less is the desirable outcome.
次要结局
- Triglyceride Levels From One Year Before to One Year After Intervention(2 years)
- Five Years Before to Two Years After Intervention in Depressed Mood and Anhedonia as Assessed by the Patient Health Questionnaire-2 (PHQ-2) (Extended Time Frame)(7 years)
- Low-density Lipoprotein (LDL) Levels From One Year Before to One Year After Intervention(2 years)
- Hemoglobin A1c (hbA1c) From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- High-density Lipoprotein (HDL) Levels From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Triglyceride Levels From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Diastolic Blood Pressure From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Number of Unique Prescribed Medication From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Medical Cost in US Dollars From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Values From One Year Before to One Year After Intervention of Depressed Mood and Anhedonia as Assessed by the Patient Health Questionnaire-2 (PHQ-2)(2 years)
- Hemoglobin A1c (hbA1c) From One Year Before to One Year After Intervention(2 years)
- Low-density Lipoprotein/High-density Lipoprotein (LDL/HDL) Ratios From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Low-density Lipoprotein (LDL) Levels From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Body Mass Index From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Systolic Blood Pressure From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Number of Prescriptions From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Number of Visits From Five Years Before to Two Years After Intervention (Extended Time Frame)(7 years)
- Low-density Lipoprotein/High-density Lipoprotein (LDL/HDL) Ratios From One Year Before to One Year After Intervention(2 years)
- High-density Lipoprotein (HDL) Levels From One Year Before to One Year After Intervention(2 years)
研究者
Amir Goren
Program Director
Geisinger Clinic