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临床试验/NCT00516620
NCT00516620已完成1 期

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

University of Toronto2 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2005年1月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
960
试验地点
2
主要终点
Body Weight

研究概览

简要总结

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.

详细描述

Governments and major national agencies throughout the western world concerned with chronic disease prevention (heart disease, stroke, diabetes, and cancer) uniformly advocate increased intakes of fruit, vegetables and whole grain cereals. All also agree that body weight reduction is central to reducing the risk of heart disease, stroke, type 2 diabetes, and certain cancers. Nevertheless, there is no official advice encouraging increased consumption of these foods in order to achieve and maintain a healthy body weight. Most importantly, there are no intervention studies that have tested the assumption that increased intake of fruit, vegetables and whole grain cereals will promote a healthier body weight. Our study will therefore address this issue to determine the effect of an increased intake of fruit, vegetables, and whole grain cereals on body weight, the intensity of effort required to achieve compliance, the durability of this habit, genetic determinants, and the effect on biomarkers of chronic disease risk.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: No further instruction (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Food Delivery (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Fruits (F), vegetables (V), and whole grain (WG) counseling (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Counseling to reduce soft drink intake. (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Food Delivery & F, V & WG counseling. (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Food delivery & soft drink counseling (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: F, V, WG & soft drink counseling (Behavioral)

1

Active Comparator

Participants receive Health Canada's Food Guide and Physical Activity guide.

干预措施: Food delivery and F,V, WG & soft drink counseling (Behavioral)

2

Active Comparator

Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food Delivery (Behavioral)

2

Active Comparator

Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food Delivery & F, V & WG counseling. (Behavioral)

2

Active Comparator

Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food delivery & soft drink counseling (Behavioral)

2

Active Comparator

Participants receive a weekly sample food basket for 6 months consisting of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food delivery and F,V, WG & soft drink counseling (Behavioral)

3

Active Comparator

Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food Delivery & F, V & WG counseling. (Behavioral)

3

Active Comparator

Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Fruits (F), vegetables (V), and whole grain (WG) counseling (Behavioral)

3

Active Comparator

Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: F, V, WG & soft drink counseling (Behavioral)

3

Active Comparator

Participants receive intensive dietary counseling for 6 months to increase intake of fruits, vegetables, whole grains, and vegetable protein products.

干预措施: Food delivery and F,V, WG & soft drink counseling (Behavioral)

4

Active Comparator

Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.

干预措施: Counseling to reduce soft drink intake. (Behavioral)

4

Active Comparator

Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.

干预措施: Food delivery & soft drink counseling (Behavioral)

4

Active Comparator

Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.

干预措施: F, V, WG & soft drink counseling (Behavioral)

4

Active Comparator

Participants receive intensive dietary counseling for 6 months to decrease intake of sweetened soft drink.

干预措施: Food delivery and F,V, WG & soft drink counseling (Behavioral)

结局指标

主要结局

Body Weight

时间窗: 18 months

次要结局

  • Biomarkers of diet and obesity-related chronic diseases (serum lipids, homocysteine and C-reactive protein) and genotypes(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Jenkins

Professor

University of Toronto

研究点 (2)

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