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

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:

MedlinePlus related topics: Coping with Chronic Illness Heart Diseases High Blood Pressure

U.S. FDA Resources

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 May 23, 2013