search
Back to results

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

Primary Purpose

Abdominal Obesity, Cardiovascular Diseases, Diabetes Type 2

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Diet A
Diet B
Physiotherapy
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity focused on measuring Blood pressure, Cereals, Diet Therapy, Dietary carbohydrates, Dietary fiber, Exercise Therapy, Food, Glucose intolerance, Lifestyle, Physiotherapy, Stroke, TIA, Waist circumference, Weight loss

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Primary Health Care Research, CRC, Lund University, Sweden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Diet A and physiotherapy

Diet B and physiotherapy

Diet A only

Diet B only

Control

Arm Description

Behavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people, i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid junk food and juice. In order to match carbohydrate intake between the arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. 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.

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. 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

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. Other Name: No grains

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. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups. Other Name: Whole grains

Only follow-up. No intervention.

Outcomes

Primary Outcome Measures

Change of waist circumference
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
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
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
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
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
Only in subjects with diabetes
Change of fasting blood sugar
Only in subjects with diabetes
Change of quantity and dosage of blood sugar-lowering drugs
All subjects will be analyzed.

Full Information

First Posted
September 23, 2010
Last Updated
June 19, 2017
Sponsor
Lund University
Collaborators
Region Skane
search

1. Study Identification

Unique Protocol Identification Number
NCT01208558
Brief Title
Grain Exercise Trial - Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Acronym
GET
Official Title
Whole Grain Versus no Grain With or Without Physiotherapy-promoted Exercise for Waist Loss
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this 2-year lifestyle experiment for waist loss is twofold: to compare whole grains and no grains as part of a healthy diet, 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Cardiovascular Diseases, Diabetes Type 2, Hypertension, Overweight
Keywords
Blood pressure, Cereals, Diet Therapy, Dietary carbohydrates, Dietary fiber, Exercise Therapy, Food, Glucose intolerance, Lifestyle, Physiotherapy, Stroke, TIA, Waist circumference, Weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet A and physiotherapy
Arm Type
Active Comparator
Arm Description
Behavioral: Diet A Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people, i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid junk food and juice. In order to match carbohydrate intake between the arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended. 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.
Arm Title
Diet B and physiotherapy
Arm Type
Active Comparator
Arm Description
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. 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
Arm Title
Diet A only
Arm Type
Active Comparator
Arm Description
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. Other Name: No grains
Arm Title
Diet B only
Arm Type
Active Comparator
Arm Description
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. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups. Other Name: Whole grains
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only follow-up. No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Diet A
Other Intervention Name(s)
No grains
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet B
Other Intervention Name(s)
Whole grains
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of waist circumference
Description
Waist circumference (at elbow level) will be measured at baseline and after 3, 6, 12 and 24 months.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change of systolic and diastolic blood pressure
Description
At baseline and after 3, 6, 12 and 24 months, sitting blood pressure will be measured twice at heart level with an automated device.
Time Frame
2 years
Title
Change of body fat percentage
Description
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).
Time Frame
2 years
Title
Change of plasma non-HDL cholesterol
Description
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.
Time Frame
2 years
Title
Change of physical activity level
Description
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.
Time Frame
2 years
Title
Change of glycated hemoglobin
Description
Only in subjects with diabetes
Time Frame
2 years
Title
Change of fasting blood sugar
Description
Only in subjects with diabetes
Time Frame
2 years
Title
Change of quantity and dosage of blood sugar-lowering drugs
Description
All subjects will be analyzed.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staffan Lindeberg, MD PhD
Organizational Affiliation
Center for Primary Health Care research, CRC, Lund University
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Primary Health Care Research, CRC, Lund University, Sweden
City
Lund
State/Province
Skane
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17583796
Citation
Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
Results Reference
background
PubMed Identifier
19604407
Citation
Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
Results Reference
background
PubMed Identifier
17983356
Citation
Kamikubo Y, Dellas C, Loskutoff DJ, Quigley JP, Ruggeri ZM. Contribution of leptin receptor N-linked glycans to leptin binding. Biochem J. 2008 Mar 15;410(3):595-604. doi: 10.1042/BJ20071137.
Results Reference
background
PubMed Identifier
16336696
Citation
Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs