Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss

Summary

The main purpose of this 2-year lifestyle experiment for waist loss is twofold:

1. to compare whole grains and no grains as part of a healthy diet,
2. to determine if an 8-week exercise program, led by physiotherapists, is more efficient than brief counseling and follow-up.

People with abdominal overweight (≥84 cm in women and ≥98 cm in men) and at least one additional cardiovascular risk factor, (typically hypertension, diabetes type 2 or prior cardiovascular disease) are randomly assigned to receive Diet A or Diet B, with or without a structured exercise program at the department of physiotherapy, or to a control group receiving usual care. Diet A and B both include fruit, vegetables, fish, meat, and low-fat dairy products, and differ only in that Diet A recommends exchange of cereal grains for more potatoes, root vegetables, fruit and other carbohydrate-rich foods, while Diet B recommends exchange of regular cereal grains for whole grains. The primary outcome (most important follow-up variable) is change in waist circumference during 2 years. Secondary outcome measures include blood pressure, blood lipids, level of physical activity and, in subjects with diabetes, glycated hemoglobin and fasting blood sugar.

Conditions

• Abdominal Obesity
• Cardiovascular Diseases
• Diabetes Type 2
• Hypertension
• Overweight

Interventions

BEHAVIORAL

Diet A

Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. Guideline: 200-400 g of potatoes, 300-500 g of root crops, 400-600 g of vegetables, 200-300 g of beans, peas and corn, and 600 g of fruit and berries per day.

BEHAVIORAL

Diet B

Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A: to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups.

BEHAVIORAL

Physiotherapy

Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end.

Sponsors & Collaborators

• Region Skane

  collaborator OTHER

• Lund University

  lead OTHER

Principal Investigators

• Staffan Lindeberg, MD PhD · Center for Primary Health Care research, CRC, Lund University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• Sweden

Study Locations