Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Condition: Abdominal Obesity; Cardiovascular Diseases; Diabetes Type 2; Hypertension; Overweight
MeSH terms: Cardiovascular Diseases; Overweight; Diabetes Mellitus, Type 2; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      This is a randomized controlled trial with 5 parallel groups of approximately equal size. Two
      hundred subjects with increased waist circumference (≥84 cm in women and ≥98 cm in men) and
      at least one additional cardiovascular risk factor will be included.

      Four of the 5 groups will receive dietary advice (A or B) and 2 of them will be allocated to
      physiotherapy. A fifth control group will only receive usual care in addition to follow-up.
      Randomization will be performed by use of an internet-based random number generator from the
      School of Computer Science and Statistics, Trinity College, Dublin (www.random.org). 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.

      In addition to primary (waist loss) and secondary outcome measures as given below, a health
      questionnaire will be performed at baseline and after 12 and 24 months with questions about
      general health, self-reported quality of life, medication use, living habits, physical
      activity, nutrition, tobacco, alcohol, personal motivation and perceived ability to change
      lifestyle. Furthermore, serum creatinine will be measured at baseline, and after 3, 6, 12 and
      24 months.

      There are few randomized controlled trials comparing the effect of different lifestyle
      interventions on physical activity level or weight loss in overweight people at high risk of
      cardiovascular disease. There is no such study of the possible effect of a structured
      exercise program with group training led by physiotherapists, with the exception of
      rehabilitation programs after myocardial infarction. In addition, the possible unique effect
      of cereal grains on satiety and energy intake has not been addressed in randomized controlled
      trials. In two earlier studies in glucose intolerance and diabetes type 2, we have applied a
      dietary model (Paleolithic diet) based on root vegetables, fruit, vegetables, meat and fish,
      partly at the expense of cereal grains (Lindeberg et al., 2007; Jönsson et al., 2009). The
      results showed a more beneficial effect on waist circumference than from traditional dietary
      advice. In one of the studies in 29 overweight men with coronary heart disease and impaired
      glucose tolerance, the decrease of waist circumference was 2.7 cm greater (p=0,03) in the
      intervention group (-5.6 cm; 95% confidence interval [CI] -7.2;-3.9) than in the control
      group (-2.9, CI -4.8;-1.1) during 3 months of follow-up (Lindeberg et al., 2007). In the
      second study, where the same dietary model was applied in cross-over design among 13 subjects
      with diabetes type 2, waist circumference decreased 4 cm more (p=0,02) during the
      intervention diet than during the control diet (Jönsson et al., 2009). There is some evidence
      to suggest that cereal grains may interfere with leptin receptor activity in a way that could
      hypothetically suppress satiety (Jönsson et al., 2005; Kamikubo et al., 2008).
    

Intervention name(s): Diet A; Diet B; Physiotherapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): No grains; Whole grains; Exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; Cereals; Diet Therapy; Dietary carbohydrates; Dietary fiber; Exercise Therapy; Food; Glucose intolerance; Lifestyle; Physiotherapy; Stroke; TIA; Waist circumference; Weight loss