Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Grain Exercise Trial (GET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Lund University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Region Skane
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT01208558
First received: September 23, 2010
Last updated: May 17, 2013
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Abdominal Obesity
Cardiovascular Diseases
Diabetes Type 2
Hypertension
Overweight
Behavioral: Diet A
Behavioral: Diet B
Behavioral: Physiotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Change of waist circumference [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Waist circumference (at elbow level) will be measured at baseline and after 3, 6, 12 and 24 months.


Secondary Outcome Measures:
  • Change of systolic and diastolic blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At baseline and after 3, 6, 12 and 24 months, sitting blood pressure will be measured twice at heart level with an automated device.

  • Change of body fat percentage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At baseline and after 12 and 24 months, total body fat percentage will be assessed by use of a Tanita hand-foot-BIA. Thickness of subcutaneous fat will be assessed by use of a Harpenden skinfold caliper at four sites (biceps, triceps, suprailiac and subscapular).

  • Change of plasma non-HDL cholesterol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Non-fasting plasma total and HDL cholesterol will be measured at baseline and after 3, 6, 12 and 24 months. HDL cholesterol will be subtracted from total cholesterol.

  • Change of physical activity level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A hip-mounted ActiGraph accelerometer will be worn daytime for six days at baseline and after 12 and 24 months for continuous monitoring of physical activity.

  • Change of glycated hemoglobin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Only in subjects with diabetes

  • Change of fasting blood sugar [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Only in subjects with diabetes

  • Change of quantity and dosage of blood sugar-lowering drugs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    All subjects will be analyzed.


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet A and physiotherapy 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; 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. 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.

Other Name: No grains
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.
Other Name: Exercise
Experimental: Diet B and physiotherapy 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.
Other Name: Whole grains
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.
Other Name: Exercise
Experimental: Diet A only 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; 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. 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.

Other Name: No grains
Experimental: Diet B only 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.
Other Name: Whole grains
No Intervention: Control

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).

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • increased waist circumference (≥84 cm in women and ≥98 cm in men)
  • AND at least one additional cardiovascular risk factor: hypertension, diabetes type 2, prior coronary heart disease, prior stroke/TIA, peripheral arterial disease, impaired glucose tolerance, prior gestational diabetes, heredity or smoking

Exclusion Criteria:

  • dependence on walking aids
  • difficulty to understand Swedish (written or spoken)
  • BMI >40 kg/m2
  • cognitive impairment
  • pronounced hearing loss
  • aphasia
  • continuous treatment with warfarin or prednisolone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208558

Locations
Sweden
Center for Primary Health Care Research, CRC, Lund University, Sweden
Lund, Skane, Sweden
Sponsors and Collaborators
Lund University
Region Skane
Investigators
Study Chair: Staffan Lindeberg, MD PhD Center for Primary Health Care research, CRC, Lund University
  More Information

Publications:
Responsible Party: Staffan Lindeberg, Center for Primary Health Care Research, Lund University, Sweden
ClinicalTrials.gov Identifier: NCT01208558     History of Changes
Other Study ID Numbers: LU2010/332
Study First Received: September 23, 2010
Last Updated: May 17, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Lund University:
Blood pressure
Cereals
Diet Therapy
Dietary carbohydrates
Dietary fiber
Exercise Therapy
Food
Glucose intolerance
Lifestyle
Physiotherapy
Stroke
TIA
Waist circumference
Weight loss

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Hypertension
Obesity, Abdominal
Overweight
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Obesity
Overnutrition
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014