Evaluation of a Letter Intervention Promoting a Plant-based Diet
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Diseases
- Diabetes Mellitus
- Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: One group of participants will not be contacted at all (n = 6200). One group will only received a letter promoting a plant-based diet (n = 2200). Twelve groups (n = 550 for each group) will receive the letter promoting a plant-based diet, along with the Forks Over Knives documentary. The documentary will be delivered through 3 different methods, and the accompanying letter will contain 4 different combinations of behavioral nudges. 1 primary control group (no contact) 1 group contacted by letter 3 groups (documentary distribution: online link, DVD, online link + DVD) x 4 groups (behavioral nudges in the letter: no nudge, commitment nudge, prevention nudge, commitment and prevention nudges) Note: The control group size is an estimate of number of participants who match the eligibility criteria but were not randomly assigned to an experimental group.Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: 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).Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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. Whil...
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.
Tracking Information
- NCT #
- NCT03880838
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Amir Goren, PhD Program Director Study Director: Henri Carlo Y Santos, PhD Post-doctoral Fellow Study Director: Christopher Chabris, PhD Professor Study Director: Michelle N Meyer, PhD, JD Assistant Professor Study Director: Allison Hess, BS Vice President
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