Fruits, Vegetables, and Whole Grains: A Community-based Intervention
NCT ID: NCT00516620
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
960 participants
INTERVENTIONAL
2005-01-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
We will ask approximately 780 families to take part in this study. We will invite households to take part if there is at least one adult who is eligible for our study, and who agrees to participate.
To be eligible for this study, participants must be at least 18 years old and have no medical conditions that would make it unsafe for them to take part. Before beginning the study, the medical history and other measures will be checked to ensure participant safety and suitability for participating in the study.
This study consists of three parts. If agreement to participate is given, the first part is to make an appointment to come to our study clinic to give a fasting blood sample (baseline measurements), about 40mL of blood. The clinic visit will last approximately 40 minutes. All participants will be asked to complete a short checklist about their medical history, which includes information to make sure that they and their household are eligible for participation. Body fat measurements will also be made using a non-invasive, very simple machine called Futrex as well as height, weight, waist-to-hip ratio, and blood pressure. Part of the blood sample will be used for a health screen to ensure subject safety and suitability for participating in the study. Blood samples will be stored in a secured location and analyzed at the end of the study for cholesterol levels and other risk factors for heart disease. Part of the blood sample will be used in DNA analysis to help us understand the genes related to food intake and metabolism. We will also ask all participants to complete a questionnaire package about their eating habits and their physical activity either prior to the clinic visit or at the end of the clinic visit. Once the questionnaires are completed and returned to the study office, the second part of the study will commence.
The second part is the intervention itself, lasting six months. If households are deemed to be eligible, they will be 'randomized' into one of eight study groups with all groups receiving Canada's Food Guide \& Physical Activity Guide. The study groups involve a combination of different kinds of dietary advice and provision of fruit, vegetables, and whole grain cereals.
* Treatment 1: no food provision or dietary advice.
* Treatment 2: food delivery.
* Treatment 3: counseling on fruit, vegetables and whole grains.
* Treatment 4: counseling to reduce soft drink intake.
* Treatment 5: food delivery AND counseling on fruit, vegetables and whole grains.
* Treatment 6: food delivery AND counseling to reduce soft drink intake.
* Treatment 7: counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
* Treatment 8: food delivery AND counseling on fruit, vegetables, whole grains AND counseling on the reduction of soft drink intake.
All food boxes are prepared and delivered by Food Share, a Toronto-based non-profit organization that has an existing system for home delivery of nutritious food boxes. If participants do receive dietary counseling, it will involve a phone call once a week for the first month (for about 20 minutes) then a phone call once a month for the next 5 months. At the end of six months, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
The third part is a follow-up 12 months after the end of the intervention. Again, participants will be asked to fill in provided questionnaires and return to the clinic to repeat the procedures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Participants receive Health Canada's Food Guide and Physical Activity guide.
No further instruction
Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
Food Delivery
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.
Fruits (F), vegetables (V), and whole grain (WG) counseling
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.
Counseling to reduce soft drink intake.
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.
Food Delivery & F, V & WG counseling.
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.
Food delivery & soft drink counseling
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.
F, V, WG & soft drink counseling
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.
Food delivery and F,V, WG & soft drink counseling
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.
2
Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
Food Delivery
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.
Food Delivery & F, V & WG counseling.
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.
Food delivery & soft drink counseling
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.
Food delivery and F,V, WG & soft drink counseling
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.
3
Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.
Fruits (F), vegetables (V), and whole grain (WG) counseling
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.
Food Delivery & F, V & WG counseling.
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.
F, V, WG & soft drink counseling
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.
Food delivery and F,V, WG & soft drink counseling
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.
4
Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.
Counseling to reduce soft drink intake.
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.
Food delivery & soft drink counseling
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.
F, V, WG & soft drink counseling
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.
Food delivery and F,V, WG & soft drink counseling
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No further instruction
Participants receive Health Canada's Food Guide and Physical Activity Guide and no other intervention for the 6 months of the intervention period.
Food Delivery
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.
Fruits (F), vegetables (V), and whole grain (WG) counseling
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.
Counseling to reduce soft drink intake.
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.
Food Delivery & F, V & WG counseling.
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.
Food delivery & soft drink counseling
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.
F, V, WG & soft drink counseling
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.
Food delivery and F,V, WG & soft drink counseling
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Unity Health Toronto
OTHER
Cancer Care Ontario
OTHER
University of Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Jenkins
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daivd JA Jenkins, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto, St. Michael's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Toronto
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Wang 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.
Jenkins 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIHR-NET 105919
Identifier Type: -
Identifier Source: secondary_id
REB 04-016C
Identifier Type: -
Identifier Source: org_study_id