Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

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 (SD/PA-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
    

Intervention name(s): health education; food supplementation; food supplementation combined with physical activity program
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lifestyle; diet; exercise; physical activity; obesity