NCT00356785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2001

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
Last Updated

July 26, 2006

Status Verified

April 1, 2006

First QC Date

July 25, 2006

Last Update Submit

July 25, 2006

Conditions

ObesityMetabolic Syndrome

Keywords

lifestyledietexercisephysical activityobesity

Outcome Measures

Primary Outcomes (2)

  • body weight loss of more than 5%

  • body weight loss of more than 10%

Secondary Outcomes (6)

  • reduction of body fat

  • change of muscle mass

  • change in blood pressure

  • change in lipids

  • change in fasting blood glucose

  • +1 more secondary outcomes

Interventions

health educationBEHAVIORAL
food supplementationBEHAVIORAL
food supplementation combined with physical activity programBEHAVIORAL

Eligibility Criteria

Age34 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants must have overweight with a BMI between 27,5 and 35 kg/m²
  • The participants must be able to participate in a physical activity program
  • The participants must be willing to participate in the program for 1 year
  • Written informed consent must be given to accept randomization to either of the intervention groups

You may not qualify if:

  • Participants who do not meet all entry criteria
  • BMI \> 35,0 kg / m²
  • Performance capacity \< 75 w for 2 min
  • Subjects younger than 35 yrs (with reference age at 1st Jan 2002: 34.5 yrs) or older than 65 yrs (with reference age at 1st 2002: 65.5 yrs)
  • Absolute or relative contraindications to exercise testing of the ACSM
  • Persons unable or with restrictions to participate in a regular physical activity program because of any disease (e.g. history of CHD, arrhythmia, valvular heart disease, arthritis of major joints)
  • Severe hypertension systolic BP of \> 200 mm Hg and or diastolic BP of \> 105 mm Hg at rest
  • Persons with established insulin dependent diabetes mellitus (IDDM)
  • Persons with a disease of the liver or the kidneys prohibiting high protein intake
  • Persons with a disease of the thyroid gland or taking thyroid hormones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Department for Rehabilitation, Prevention and Sports Medicine

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (2)

  • Deibert P, Konig D, Schmidt-Trucksaess A, Zaenker KS, Frey I, Landmann U, Berg A. Weight loss without losing muscle mass in pre-obese and obese subjects induced by a high-soy-protein diet. Int J Obes Relat Metab Disord. 2004 Oct;28(10):1349-52. doi: 10.1038/sj.ijo.0802765.

    PMID: 15303108RESULT

  • Koohkan S, Schaffner D, Milliron BJ, Frey I, Konig D, Deibert P, Vitolins M, Berg A. The impact of a weight reduction program with and without meal-replacement on health related quality of life in middle-aged obese females. BMC Womens Health. 2014 Mar 12;14(1):45. doi: 10.1186/1472-6874-14-45.

    PMID: 24618460DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeMotor Activity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Aloys Berg, Prof.Dr.

    University Hospital, Department for Rehabilitation, Prevention and Sports Medicine, Freiburg, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2001

Last Updated

July 26, 2006

Record last verified: 2006-04

Locations

DE(1)