Diabetes Reversal Online Program and Study (DROP Study)

NCT ID: NCT05572502

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2027-12-31

Brief Summary

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This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.

Detailed Description

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This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 12-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group, multiple replications
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vegan diet

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Group Type EXPERIMENTAL

plant-based diet

Intervention Type BEHAVIORAL

For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study

Interventions

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plant-based diet

For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study

Intervention Type BEHAVIORAL

Other Intervention Names

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vegan diet

Eligibility Criteria

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Inclusion Criteria

* U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states
* Prior diagnosis of type 2 diabetes mellitus

Exclusion Criteria

* Use of recreational drugs in the past 6 months
* Pregnancy or intention to become pregnant during the study period, as verified by self-report
* Unstable medical or psychiatric illness
* Lack of English fluency
* Inability to maintain current medication regimen
* Inability or unwillingness to participate in all components of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Physicians Committee for Responsible Medicine

OTHER

Sponsor Role lead

Responsible Party

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Vanita Rahman

Clinic Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neal Barnard, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Committee for Responsible Medicine

Locations

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Physician Committee for Responsible Medicine

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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VANITA RAHMAN, MD

Role: CONTACT

2025277500

Roxanne Becker, MBChB

Role: CONTACT

2022779760

Facility Contacts

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VANITA RAHMAN, MD

Role: primary

202-527-7500

Roxanne Becker, MBChB

Role: backup

2022779760

References

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Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.

Reference Type BACKGROUND
PMID: 19351712 (View on PubMed)

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

Reference Type BACKGROUND
PMID: 16873779 (View on PubMed)

Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31.

Reference Type BACKGROUND

Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.

Reference Type BACKGROUND

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004.

Reference Type BACKGROUND
PMID: 15286527 (View on PubMed)

Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.

Reference Type BACKGROUND
PMID: 19167953 (View on PubMed)

American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.

Reference Type BACKGROUND
PMID: 12778049 (View on PubMed)

Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.

Reference Type BACKGROUND
PMID: 7842153 (View on PubMed)

Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.

Reference Type BACKGROUND

U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.

Reference Type BACKGROUND

Other Identifiers

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Pro00066361

Identifier Type: -

Identifier Source: org_study_id

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