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Evaluation of a Letter Intervention Promoting a Plant-based Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880838
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Amir Goren, Geisinger Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diabetes Mellitus Obesity Behavioral: Personal testimonial Behavioral: Forks Over Knives Documentary Behavioral: Commitment nudge Behavioral: Prevention nudge Not Applicable

Detailed 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. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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
Official Title: 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
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : March 29, 2020
Estimated Study Completion Date : March 29, 2022

Arm Intervention/treatment
No Intervention: No contact control
Participants are not contacted.
Experimental: Letter
Participants are only contacted through a letter with a personal testimonial.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Experimental: Link and no nudge
Participants are sent the Forks Over Knives documentary online link and a letter with a personal testimonial and no nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Experimental: Link and commitment nudge
Participants are sent the Forks Over Knives documentary online link and a letter with a personal testimonial and a commitment nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: Link and prevention nudge
Participants are sent the Forks Over Knives documentary online link and a letter with a personal testimonial and a prevention nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: Link and both nudges
Participants are sent the Forks Over Knives documentary online link and a letter with a personal testimonial and both commitment and prevention nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: DVD and no nudge
Participants are sent the Forks Over Knives documentary DVD and a letter with a personal testimonial and no behavioral nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Experimental: DVD and commitment nudge
Participants are sent the Forks Over Knives documentary DVD and a letter with a personal testimonial and a commitment nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: DVD and prevention nudge
Participants are sent the Forks Over Knives documentary DVD and a letter with a personal testimonial and a prevention nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: DVD and both nudges
Participants are sent the Forks Over Knives documentary DVD and a letter with a personal testimonial and both commitment and prevention nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: Link and DVD and no nudge
Participants are sent the Forks Over Knives documentary online link and DVD and a letter with a personal testimonial and no behavioral nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Experimental: Link and DVD and commitment nudge
Participants are sent the Forks Over Knives documentary online link and DVD and a letter with a personal testimonial and a commitment nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: Link and DVD and prevention nudge
Participants are sent the Forks Over Knives documentary online link and DVD and a letter with a personal testimonial and a prevention nudge.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Experimental: Link and DVD and both nudges
Participants are sent the Forks Over Knives documentary online link and DVD and a letter with a personal testimonial and both commitment and prevention nudges.
Behavioral: Personal testimonial
Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.

Behavioral: Forks Over Knives Documentary
Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.

Behavioral: Commitment nudge
At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.

Behavioral: Prevention nudge
As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.




Primary Outcome Measures :
  1. Change in medical cost in US Dollars from one year before to one year after intervention [ Time Frame: Assessing change with general linear models between two points: sum of costs during one year before the intervention date and sum of costs during one year after the intervention date ]
    Total annual amount of medical and pharmacy costs (sum) as reported by Geisinger Health Plan. Lower costs is the desirable outcome.

  2. Change in number of visits from one year before to one year after intervention [ Time Frame: Assessing change with general linear models between two points: number of visits during one year before the intervention date and number of visits during one year after the intervention date ]
    Total number of primary care physician and specialist visits (sum) as reported by Geisinger Health Plan. Fewer visits is the desirable outcome.

  3. Change in number of prescriptions from one year before to one year after intervention [ Time Frame: Assessing change with general linear models between two points: number of prescriptions during one year before the intervention date and number of prescriptions during one year after the intervention date ]
    Total number of prescriptions (standard unit is prescription per number of days supplied) as reported by Geisinger Health Plan. Fewer prescriptions is the desirable outcome.

  4. Change in number of unique prescribed medication from one year before to one year after intervention [ Time Frame: Assessing change with general linear models between two points: number of unique prescribed medication during one year before the intervention date and number of unique prescribed medication during one year after the intervention date ]
    Total number of unique prescribed medication in the past year as reported by Geisinger Health Plan. Less unique prescribed medication is the desirable outcome.

  5. Change in body mass index from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Computed from height (in meters) and weight (in kilograms) data with the formula kilograms/meters^2. A body mass index between the range of 18.5 to 25 is the desirable outcome.

  6. Change in systolic blood pressure from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Systolic blood pressure that is 120 millimeters of mercury (mmHG) or less is the desirable outcome.

  7. Change in diastolic blood pressure from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Systolic blood pressure that is 80 millimeters of mercury (mmHG) or less is the desirable outcome.


Secondary Outcome Measures :
  1. Change in triglyceride levels from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. A triglyceride level of 150 milligrams per deciliter (mg/dl) or lower is the desirable outcome.

  2. Change in low-density lipoprotein (LDL) levels from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. An LDL level of 100 milligrams per deciliter (mg/dl) or lower is the desirable outcome.

  3. Change in high-density lipoprotein (HDL) levels from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. An HDL level of 60 milligrams per deciliter (mg/dl) or higher is the desirable outcome.

  4. Change in low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratios from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Computed as the ratio of LDL/HDL. An LDL/HDL ratio of 3 or less for men and 2.5 or less for women is the desirable outcome.

  5. Change in hemoglobin A1c (hbA1c) from one year before to one year after intervention [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Test for diabetes, used if data is on health record. Percentage score reflects blood-glucose levels. An hbA1c level of 5.7% or lower is the desirable outcome.

  6. Change from one year before to one year after intervention in depressed mood and anhedonia as assessed by the Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from one year before the intervention date to one year after the intervention date, with at least one data point before and after the intervention date ]
    Assesses depressed mood and anhedonia in the past two weeks; used if data is on health record. The sum of two items (each scored 0-3) is computed with a total score range of 0-6. A lower score is the desired outcome.

  7. Change in medical cost in US Dollars from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (sum computed for each year from the intervention date) covering 5 years before the intervention date to 2 years after the intervention date ]
    Total annual amount of medical and pharmacy costs (sum) as reported by Geisinger Health Plan. Lower costs is the desirable outcome.

  8. Change in number of visits from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (sum computed for each year from the intervention date) covering 5 years before the intervention date to 2 years after the intervention date ]
    Total number of primary care physician and specialist visits (sum) as reported by Geisinger Health Plan. Fewer visits is the desirable outcome.

  9. Change in number of prescriptions from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (sum computed for each year from the intervention date) covering 5 years before the intervention date to 2 years after the intervention date ]
    Total number of prescriptions (standard unit is prescription per number of days supplied) as reported by Geisinger Health Plan. Fewer prescriptions is the desirable outcome.

  10. Change in number of unique prescribed medication from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (sum computed for each year from the intervention date) covering 5 years before the intervention date to 2 years after the intervention date ]
    Total number of unique prescribed medication in the past year as reported by Geisinger Health Plan. Less unique prescribed medication is the desirable outcome.

  11. Change in body mass index from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as checkup dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Computed from height (in meters) and weight (in kilograms) data with the formula kilograms/meters^2. A body mass index between the range of 18.5 to 25 is the desirable outcome.

  12. Change in systolic blood pressure from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as checkup dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Systolic blood pressure that is 120 millimeters of mercury (mmHG) or less is the desirable outcome.

  13. Change in diastolic blood pressure from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as checkup dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Taken from annual checkup with primary care provider. Systolic blood pressure that is 80 millimeters of mercury (mmHG) or less is the desirable outcome.

  14. Change in triglyceride levels from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. A triglyceride level of 150 milligrams per deciliter (mg/dl) or lower is the desirable outcome.

  15. Change in low-density lipoprotein (LDL) levels from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. An LDL level of 100 milligrams per deciliter (mg/dl) or lower is the desirable outcome.

  16. Change in high-density lipoprotein (HDL) levels from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    One component of cholesterol, used if data is on health record. An HDL level of 60 milligrams per deciliter (mg/dl) or higher is the desirable outcome.

  17. Change in low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratios from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Computed as the ratio of LDL/HDL. An LDL/HDL ratio of 3 or less for men and 2.5 or less for women is the desirable outcome.

  18. Change in hemoglobin A1c (hbA1c) from five years before to two years after intervention (extended time frame) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Test for diabetes, used if data is on health record. Percentage score reflects blood-glucose levels. An hbA1c level of 5.7% and below is the desirable outcome.

  19. Change from 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) [ Time Frame: Assessing change with general linear models covering all available data (as assessment dates may vary) from 5 years before the intervention date to 2 years after the intervention date, with at least one data point before and after the intervention date ]
    Assesses depressed mood and anhedonia in the past two weeks; used if data is on health record. The sum of two items (each scored 0-3) is computed with a total score range of 0-6. A lower score is the desired outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • Medicaid
    • Individual policy under the Affordable Care Act
  • Has visited their primary care provider in the past 12 months

Exclusion Criteria:

  • Is institutionalized
  • Has active cancer, cirrhosis, renal failure, dementia, or active psychosis
  • Is in the same household as another selected participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880838


Contacts
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Contact: Amir Goren, PhD 5702144395 agoren@geisinger.edu
Contact: Henri Carlo Y Santos, PhD hsantos@geisinger.edu

Sponsors and Collaborators
Geisinger Clinic
Investigators
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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

Additional Information:
Publications:
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Responsible Party: Amir Goren, Program Director, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03880838     History of Changes
Other Study ID Numbers: 2019-0179
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include preregistered hypotheses, analysis plan and code, and the essential data needed to replicate the analysis that yielded reported findings.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The data will become available after the completion of analysis and will be available as long as the Open Science Framework hosts the data.
Access Criteria: The data on the Open Science Framework will be open to anyone requesting that information.
URL: http://osf.io

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amir Goren, Geisinger Clinic:
Plant-based diet
Behavioral nudge
Mail distribution
Randomized controlled trial
Insurance claims
Chronic disease
Letter-based intervention
Health behaviors
Prevention focus
Loss framing
Commitment
Provider testimonial

Additional relevant MeSH terms:
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Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases