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

Sponsors and Collaborators:	University of Toronto St. Michael's Hospital, Toronto Cancer Care Ontario
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00516620

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 I

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title:	Fruits, Vegetables, and Whole Grains: A Community-Based Intervention

Further study details as provided by University of Toronto:

Primary Outcome Measures:

Body Weight [ Time Frame: 18 months ]

Secondary Outcome Measures:

Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes [ Time Frame: 18 months ]

Estimated Enrollment:	780
Study Start Date:	January 2005

Arms	Assigned Interventions
1: Active Comparator Participants receive Canada's Food Guide and Physical Activity guide.	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
2: Active Comparator Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.	Behavioral: Food Delivery Behavioral: Food Delivery & F, V & WG counseling. Behavioral: Food delivery & soft drink counseling Behavioral: Food delivery and F,V, WG & soft drink counseling
3: Active Comparator 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 Behavioral: Food Delivery & F, V & WG counseling. Behavioral: F, V, WG & soft drink counseling Behavioral: Food delivery and F,V, WG & soft drink counseling
4: Active Comparator Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.	Behavioral: Counseling to reduce soft drink intake. Behavioral: Food delivery & soft drink counseling Behavioral: F, V, WG & soft drink counseling Behavioral: Food delivery and F,V, WG & soft drink counseling

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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

Exclusion Criteria:

Subjects 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
Treatment for hypothyroidism, recent addition of diuretics, or diabetes, liver disease, renal failure, cancer (or a history of malignancy), inflammatory bowel disease, irritable bowel syndrome, peanut or nut allergy, or major surgery in the previous 6 months
Blood pressure greater than 145/95 on repeated measurements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516620

Contacts

Contact: David JA Jenkins, MD, PhD

416-867-7475

cyril.kendall@utoronto.ca

Locations

Canada, Ontario
University of Toronto	Recruiting
Toronto, Ontario, Canada, M5S 3E2
Principal Investigator: David JA Jenkins, MD, PhD

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

Study ID Numbers:	REB 04-016C, CIHR-NET 105919
Study First Received:	August 13, 2007
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00516620
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:

Body Weight

Study placed in the following topic categories:

Body Weight
Heart Diseases
Vascular Diseases
Diabetes Mellitus
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009