OverweightNCT04222894
Hospital Workplace Nutrition Study
A study testing Plant-based diet in people with Overweight and Type2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Type2 Diabetes
- What is being tested?
- Plant-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee of Sibley hospital
- Male or female
- Age at least 18 years
- Have a BMI >25 kg/m2
- Ability and willingness to participate in all components of the study
- A willingness to follow a plant-based diet for the duration of the study
- A willingness to attend weekly classes for the duration of the study
- A willingness to keep physical activity level consistent throughout the duration of the study
Who cannot join
- Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
- Smoking during the past six months
- Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- Current or unresolved past drug abuse
- Pregnancy or plans to become pregnant in the next 12 weeks
- Intention to leave hospital employment in the next 12 weeks
Show all 10Show fewer
- Unstable medical or psychiatric status
- Evidence of an eating disorder
- Lack of English fluency
- Inability to maintain current medication regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.
Read the detailed description
Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.
- Conditions
- Overweight, Type2 Diabetes
- Being tested
- Plant-based diet, Control Diet
- Keywords
- body weight, blood pressure, lipids, nutrition
- Medical subject headings
- Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietOther
Also called Vegan diet
Weekly instructions will be given to the participants in the intervention group about following vegan diet.
Control DietOther
Participants will be asked to continue their usual diets for the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based diet | Active comparator | The diet group will be asked to follow a low-fat, vegan diet for 12 weeks Receives: Other: Plant-based diet |
| Control diet | Active comparator | Half of the participants will be asked to continue their usual diets for the 12-week study period. Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Anticipated weight-loss for intervention group compared with control group
Measured: 12 weeks
Blood Pressure
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Measured: 12 weeks
Plasma Lipids
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
Measured: 12 weeks
Secondary outcomes (6)
Hemoglobin A1c
HbA1c will be measured as an index of glycemic control.
Measured: 12 weeks
Fasting Plasma Glucose
Fasting Plasma Glucose will be measured as an index of glycemic control.
Measured: 12 weeks
Absenteeism
Absenteeism from work will be assessed by self-report at baseline and final assessments.
Measured: 12 weeks
Quality of Life: SF-36
Quality of life will be assessed using the SF-36, which is a brief health survey with 36 questions. The SF-36 provides an 8-scale profile of functional health and well-being scores, as well as psychometrically-based physical and mental health summary measures. The SF-36 is a general measure that has been administered across various age groups, disease spectra, and treatment regimens. Items on the SF-36 are scored on a scale of 0-100, with a higher score indicating better health-related quality of life.
Measured: 12 weeks
Dietary Restraint, Disinhibition, Hunger
Participants will complete an Eating Inventory form, a highly reliable 51 item questionnaire providing quantitative measures of dietary restraint (21 questions), disinhibition (16 items), and hunger (14 questions). Scores for each sub-scale are calculated by summing respective items. The scale consists of 36 true=false items and 15 forced-choice format questions. Higher scores are indicative of greater dietary restraint, disinhibition and hunger. Its principal use in the current study will be as a gauge of ease in adapting to the intervention diet, which is indicated by changes in restraint and hunger scores.
Measured: 12 weeks
Food Acceptability: The Food Acceptability Questionnaire
The Food Acceptability Questionnaire will measure attitudes about the intervention diet, including desire to adhere, likelihood to adhere in the future, and attitudes about accessibility of sustaining the diet. Items on the FAQ are scored on a scale of 1-7. Higher scores indicate greater food acceptability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start26 Jun 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sibley Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Neal D Barnard, MD, Principal investigator, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222894
- Sponsor's protocol ID
- Pro00038823
- Status last verified
- Apr 2022
- First submitted
- 7 Jan 2020
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
PubMed 12365955Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
PubMed 15199035Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.
PubMed 24512862Dayoub E, Jena AB. Chronic Disease Prevalence and Healthy Lifestyle Behaviors Among US Health Care Professionals. Mayo Clin Proc. 2015 Dec;90(12):1659-62. doi: 10.1016/j.mayocp.2015.08.002. Epub 2015 Oct 5.
PubMed 26422242Vibhute NA, Baad R, Belgaumi U, Kadashetti V, Bommanavar S, Kamate W. Dietary habits amongst medical students: An institution-based study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1464-1466. doi: 10.4103/jfmpc.jfmpc_154_18.
PubMed 30613543Bergeron N, Al-Saiegh S, Ip EJ. An Analysis of California Pharmacy and Medical Students' Dietary and Lifestyle Practices. Am J Pharm Educ. 2017 Oct;81(8):5956. doi: 10.5688/ajpe5956.
PubMed 29200450Bleich SN, Bennett WL, Gudzune KA, Cooper LA. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012 May;20(5):999-1005. doi: 10.1038/oby.2011.402. Epub 2012 Jan 19.
PubMed 22262162Barnard ND, Scialli AR, Bertron P, Hurlock D, Edmonds K, Talev L. Effectiveness of a low-fat vegetarian diet in altering serum lipids in healthy premenopausal women. Am J Cardiol. 2000 Apr 15;85(8):969-72. doi: 10.1016/s0002-9149(99)00911-x.
PubMed 10760336Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.
PubMed 24566947Barnard 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.
PubMed 16873779Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
PubMed 10496449Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995 Dec;41(6):560-8.
PubMed 7500065Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
PubMed 1973470Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.
PubMed 19562864Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
PubMed 4337382
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Workplace Nutrition Study (Sibley Memorial Hospital)
- ClinicalTrials.gov ID
- NCT04222894
- Acronym / sponsor ID
- Pro00038823
- Conditions
- Overweight, Type2 Diabetes
- Keywords
- body weight, blood pressure, lipids, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Collaborators
- Sibley Memorial Hospital
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.
Detailed description
Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Active comparator | Other: Plant-based dietThe diet group will be asked to follow a low-fat, vegan diet for 12 weeks |
| Control diet | Active comparator | Other: Control DietHalf of the participants will be asked to continue their usual diets for the 12-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Employee of Sibley hospital
- Male or female
- Age at least 18 years
- Have a BMI >25 kg/m2
- Ability and willingness to participate in all components of the study
Key exclusion criteria (10 listed)
- Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
- Smoking during the past six months
- Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- Current or unresolved past drug abuse
- Pregnancy or plans to become pregnant in the next 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based dietAlso: Vegan dietWeekly instructions will be given to the participants in the intervention group about following vegan diet. | Other | Plant-based diet |
| Control DietParticipants will be asked to continue their usual diets for the 12-week study period. | Other | Control diet |
Primary outcome
Body Weight
Time frame: 12 weeks
Anticipated weight-loss for intervention group compared with control group
Blood Pressure
Time frame: 12 weeks
Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group
Plasma Lipids
Time frame: 12 weeks
Anticipated changes in plasma lipid concentrations for intervention group compared with control group
6 secondary outcomes
Hemoglobin A1c
Time frame: 12 weeks
Fasting Plasma Glucose
Time frame: 12 weeks
Absenteeism
Time frame: 12 weeks
Quality of Life: SF-36
Time frame: 12 weeks
Dietary Restraint, Disinhibition, Hunger
Time frame: 12 weeks
Food Acceptability: The Food Acceptability Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 12365955Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
- Background: PubMed 15199035Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
- Background: PubMed 24512862Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.
- Background: PubMed 26422242Dayoub E, Jena AB. Chronic Disease Prevalence and Healthy Lifestyle Behaviors Among US Health Care Professionals. Mayo Clin Proc. 2015 Dec;90(12):1659-62. doi: 10.1016/j.mayocp.2015.08.002. Epub 2015 Oct 5.
- Background: PubMed 30613543Vibhute NA, Baad R, Belgaumi U, Kadashetti V, Bommanavar S, Kamate W. Dietary habits amongst medical students: An institution-based study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1464-1466. doi: 10.4103/jfmpc.jfmpc_154_18.
- Background: PubMed 29200450Bergeron N, Al-Saiegh S, Ip EJ. An Analysis of California Pharmacy and Medical Students' Dietary and Lifestyle Practices. Am J Pharm Educ. 2017 Oct;81(8):5956. doi: 10.5688/ajpe5956.
- Background: PubMed 22262162Bleich SN, Bennett WL, Gudzune KA, Cooper LA. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012 May;20(5):999-1005. doi: 10.1038/oby.2011.402. Epub 2012 Jan 19.
- Background: PubMed 10760336Barnard ND, Scialli AR, Bertron P, Hurlock D, Edmonds K, Talev L. Effectiveness of a low-fat vegetarian diet in altering serum lipids in healthy premenopausal women. Am J Cardiol. 2000 Apr 15;85(8):969-72. doi: 10.1016/s0002-9149(99)00911-x.
- Background: PubMed 24566947Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.
- Background: PubMed 16873779Barnard 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.
- Background: PubMed 10496449Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
- Background: PubMed 7500065Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995 Dec;41(6):560-8.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal D Barnard, MD principal investigator
President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet in people with Overweight and Type2 Diabetes, run by Physicians Committee for Responsible Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222894, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.