Fruits, Vegetables, and Whole Grains: A Community-based Intervention
2 other identifiers
interventional
960
1 country
1
Brief Summary
The aim of this study is to see if the investigators can encourage people to eat more fruits, vegetables and whole grains and drink less pop by giving them advice about their diet, or by providing them with samples of different kinds of foods. The investigators are interested in the effect this has on reducing the risk of chronic disease. The investigators will also be investigating how certain genes affect the choices people make about the foods they eat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 13, 2007
CompletedFirst Posted
Study publicly available on registry
August 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 9, 2015
December 1, 2015
6.3 years
August 13, 2007
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Weight
18 months
Secondary Outcomes (1)
Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes
18 months
Study Arms (4)
1
ACTIVE COMPARATORParticipants receive Health Canada's Food Guide and Physical Activity guide.
2
ACTIVE COMPARATORParticipants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
3
ACTIVE COMPARATORParticipants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.
4
ACTIVE COMPARATORParticipants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.
Interventions
Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
Participants receive Canada's Food Guide and Physical Activity guide, in addition to a a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
Participants receive Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling to increase intake of fruits, vegetables, whole grains, and vegetable protein products. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Participants receive Health Canada's Food Guide and Physical Activity guide, a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Participants receive Health Canada's Food Guide and Physical Activity guide, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counseling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Participants receive Health Canada's Food Guide and Physical Activity guide, receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products, and intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products, and also to decrease intake of sweetened soft drink. The counselling frequency will be weekly intervals for the first month, and then monthly sessions for the second to sixth months.
Eligibility Criteria
You may qualify if:
- residents of households within the City of Toronto 416 calling area
- respond to advertisements in newspaper, on radio, and from flyers
- Eligible households will include at least one willing adult 18 years or older; able to communicate in English, at least one adult with BMI \>/= 25
- Pregnant and breastfeeding mothers who fit the criteria above are eligible to join the study 6 months post-partum or 6 months after the cessation of breastfeeding
You may not qualify if:
- Residing outside of the 416 area code
- under 18 years of age
- actively following a special diet or weight-loss program
- major cardiovascular event in the previous 6 months
- recently (past 6 months) started blood pressure medication
- diabetes, liver disease, renal failure, cancer (or a history of malignancy), inflammatory bowel disease, individuals with acute or chronic infections, either bacterial or viral, or individuals suffering from chronic inflammatory diseases, irritable bowel syndrome, peanut or nut allergy, major surgery in the previous 6 months
- blood pressure greater than 145/95 on repeated measurements will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Unity Health Torontocollaborator
- Cancer Care Ontariocollaborator
Study Sites (1)
University of Toronto
Toronto, Ontario, M5S 3E2, Canada
Related Publications (3)
Jamnik J, Villa CR, Dhir SB, Jenkins DJA, El-Sohemy A. Prevalence of positive coeliac disease serology and HLA risk genotypes in a multiethnic population of adults in Canada: a cross-sectional study. BMJ Open. 2017 Oct 6;7(10):e017678. doi: 10.1136/bmjopen-2017-017678.
PMID: 39272232DERIVEDWang J, Jamnik J, Garcia-Bailo B, Nielsen DE, Jenkins DJA, El-Sohemy A. ABO Genotype Does Not Modify the Association between the "Blood-Type" Diet and Biomarkers of Cardiometabolic Disease in Overweight Adults. J Nutr. 2018 Apr 1;148(4):518-525. doi: 10.1093/jn/nxx074.
PMID: 29659952DERIVEDJenkins DJA, Boucher BA, Ashbury FD, Sloan M, Brown P, El-Sohemy A, Hanley AJ, Willett W, Paquette M, de Souza RJ, Ireland C, Kwan N, Jenkins A, Pichika SC, Kreiger N. Effect of Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factors. J Am Coll Cardiol. 2017 Mar 7;69(9):1103-1112. doi: 10.1016/j.jacc.2016.10.089.
PMID: 28254171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daivd JA Jenkins, MD, PhD
University of Toronto, St. Michael's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 13, 2007
First Posted
August 15, 2007
Study Start
January 1, 2005
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
December 9, 2015
Record last verified: 2015-12