Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356785
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2006-07-25
Brief Title:
Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Body Compositional and Endocrine-Metabolic Changes by Long-Term Lifestyle Intervention With Health Education Diet Almased Physical Activity or a Combination of Diet and Physical Activity in Overweight and Obese Persons
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eligible overweight and obese persons will be randomized to one of three controlled groups 1 group of participants is treated by health education for life style intervention only The other 2 groups will be included in a dietary program with an individually dosed food supplement Almased for an initial weight reduction for a period of 6 weeks The following 18 weeks represent the most important phase of weight loss and attitude the participants take part in 2 different interventions according to their randomization One group will continue the dietary program one group will try to achieve and maintain weight reduction by continuing the initial dietary program together with an additional physical activity program For all intervention groups the following 6 months aim at a further stabilization of weight and attitude now without defined guidelines of intervention but with the intention to continue the so far practiced change in life style All participants will be supplied with adequate information and material concerning the desired change in life style
Detailed Description:
Obese and adipose participants are randomized to three intervention groups During the first six weeks of the program the subjects assigned to the substitutional diet group SD-G were instructed to replace two daily meals with a commercially available soy-joghurt-honey preparation Almased During the following 18 weeks only one daily meal was replaced by the preparation The dietary intake of fat during this second phase was not to exceed 60g per day The first 6-week diet contained about 1000 kcal per day for women and 1200 kcal for men and then in the following weeks aimed at a maximum of 1500 kcal for women and 1700 kcal for men In addition a second group of subjects were encouraged to additionally attend a 60-minute physical activity endurance program twice weekly Otherwise they were to follow the same rules as the substitutional diet group SDPA-G
The lifestyle education group LE-G attended after enrolment three teaching sessions bi-monthly and had individual consultations during weeks 6 24 and 48 All sessions were held by experts in nutritional counselling Subjects received a diet-overview handout in accordance with the German Society of Nutrition and the German Society of Sports Medicine and Prevention Prescribed was a moderate-fat nutrient-balanced reduction diet consisting of 1200 to 1500 kcal per day for women and 1500 to 1800 kcal per day for men with approximately 60 percent of the calories coming from carbohydrates 25 percent from fat and 15 percent from protein
The data collected at enrolment and after 6 24 and 48 weeks were body weight waist and abdominal circumference self-reported medical history blood pressure glucose insulin serum lipids and inflammatory markers C-reactive protein IL-6 For measurement of body composition the technique of air displacement plethysmography was used Bod Pod Dietary compliance was estimated by 24-hour recalls of dietary consumption
Endpoints Body weight loss of 5 and 10 Reduction of body fat Change of muscle mass
The lifestyle education group LE-G attended after enrolment three teaching sessions bi-monthly and had individual consultations during weeks 6 24 and 48 All sessions were held by experts in nutritional counselling Subjects received a diet-overview handout in accordance with the German Society of Nutrition and the German Society of Sports Medicine and Prevention Prescribed was a moderate-fat nutrient-balanced reduction diet consisting of 1200 to 1500 kcal per day for women and 1500 to 1800 kcal per day for men with approximately 60 percent of the calories coming from carbohydrates 25 percent from fat and 15 percent from protein
The data collected at enrolment and after 6 24 and 48 weeks were body weight waist and abdominal circumference self-reported medical history blood pressure glucose insulin serum lipids and inflammatory markers C-reactive protein IL-6 For measurement of body composition the technique of air displacement plethysmography was used Bod Pod Dietary compliance was estimated by 24-hour recalls of dietary consumption
Endpoints Body weight loss of 5 and 10 Reduction of body fat Change of muscle mass
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None