Fruits, Vegetables, and Whole Grains: A Community-based Intervention

This study has been completed.
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Cancer Care Ontario
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00516620
First received: August 13, 2007
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Heart Disease
Diabetes
Hypertension
Behavioral: No further instruction
Behavioral: Food Delivery
Behavioral: Fruits (F), vegetables (V), and whole grain (WG) counseling
Behavioral: Counseling to reduce soft drink intake.
Behavioral: Food Delivery & F, V & WG counseling.
Behavioral: Food delivery & soft drink counseling
Behavioral: F, V, WG & soft drink counseling
Behavioral: Food delivery and F,V, WG & soft drink counseling
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fruits, Vegetables, and Whole Grains: A Community-based Intervention

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: January 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants receive Health Canada's Food Guide and Physical Activity guide.
Behavioral: 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.
Other Name: Control
Behavioral: 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.
Other Name: Food Delivery
Behavioral: 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.
Other Name: Fruit, Vegetable and Whole Grain Counseling
Behavioral: 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.
Other Name: Sweetened Soft Drink Counseling
Behavioral: 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.
Other Name: Food Delivery, Fruit, Vegetable and Whole Grain Counseling
Behavioral: 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.
Other Name: Food Delivery, and Sweetened Soft Drink Counseling
Behavioral: 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.
Other Name: Fruit, Vegetable, Whole Grain, Sweetened Soft Drink Counseling
Behavioral: 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 Name: Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink Counseling
Active Comparator: 2
Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.
Behavioral: 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.
Other Name: Food Delivery
Behavioral: 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.
Other Name: Food Delivery, Fruit, Vegetable and Whole Grain Counseling
Behavioral: 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.
Other Name: Food Delivery, and Sweetened Soft Drink Counseling
Behavioral: 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 Name: Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink Counseling
Active Comparator: 3
Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.
Behavioral: 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.
Other Name: Fruit, Vegetable and Whole Grain Counseling
Behavioral: 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.
Other Name: Food Delivery, Fruit, Vegetable and Whole Grain Counseling
Behavioral: 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.
Other Name: Fruit, Vegetable, Whole Grain, Sweetened Soft Drink Counseling
Behavioral: 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 Name: Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink Counseling
Active Comparator: 4
Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.
Behavioral: 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.
Other Name: Sweetened Soft Drink Counseling
Behavioral: 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.
Other Name: Food Delivery, and Sweetened Soft Drink Counseling
Behavioral: 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.
Other Name: Fruit, Vegetable, Whole Grain, Sweetened Soft Drink Counseling
Behavioral: 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 Name: Food Delivery, Fruit, Vegetable, Whole Grain, and Sweetened Soft Drink Counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Individuals who fit the inclusion criteria but recently (past 6 months) started blood pressure medication are eligible for the study once their blood pressure is under control
  • Individuals who fit the inclusion criteria but recently started hypothyroid medication or diuretics will be eligible after 1 month of treatment

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516620

Locations
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 3E2
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Cancer Care Ontario
Investigators
Principal Investigator: Daivd JA Jenkins, MD, PhD University of Toronto, St. Michael's Hospital
  More Information

No publications provided

Responsible Party: David JA Jenkins, Univerisity of Toronto
ClinicalTrials.gov Identifier: NCT00516620     History of Changes
Other Study ID Numbers: REB 04-016C, CIHR-NET 105919
Study First Received: August 13, 2007
Last Updated: July 12, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:
Body Weight

Additional relevant MeSH terms:
Heart Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014