Effect of Weight Management Programs on Cardiometabolic Risk Profile in Overweight Women
Condition: Overweight and Obesity; Dyslipoproteinemia
MeSH terms: Overweight; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of this prospective randomized study was to evaluate whether a diet with meal
      replacements can be as effective as a conventional energy-restricted modified diet on weight
      loss, body composition and cardiometabolic risk profile in overweight women. Moreover, the
      impact of these two different weight management strategies was observed on cardiometabolic
      risk profile after a self-directed weight stabilization phase following the weight loss
      phase. After that, the effect of a specific micronutrient composition with omega-3 fatty
      acids versus placebo on cardiometabolic risk was observed during a following phase of weight
      loss maintenance.
    

Detailed description: 
      Abdominal obesity, atherogenic dyslipidemia and hypertension are essential risk factors for
      cardiovascular diseases. Several studies showed favorable effects of weight loss in
      overweight subjects on cardiometabolic risk profile.

      The study was divided into a 3-month weight loss phase (phase 1), a subsequent 3-month phase
      of weight stabilization (phase 2) and a 6-month phase of weight loss maintenance (phase 3).

      For a total of 6 months subjects were randomly assigned to the meal replacement (MR) or
      control (C) group at baseline I.

      During weight loss phase both dietary intervention groups followed an energy-restricted diet
      with a balanced variety of nutrient-dense food of approximately 1200 kcal/d. The MR-WL group
      (MR group during weight loss phase) was advised to replace two of three meals every day with
      meal replacements. The C-WL group (C group during weight loss phase) was advised to follow a
      conventional energy-restricted modified diet with 15-20% of energy intake in the form of
      protein, 50-55% of energy intake in the form of carbohydrates and 30% of energy intake in the
      form of fat. All participants attended ten group training sessions for nutrition education.

      During weight stabilization phase all women of MR-S and C-S group (MR and C group during
      weight stabilization phase) were encouraged to consume a self-directed well-balanced variety
      of nutrient-dense foods without meal intervention. However, the MR-S and C-S group were
      instructed to continue the implemented nutrition advice of weight loss phase.

      At the beginning of weight loss maintenance phase (baseline II) women were randomly assigned
      to the verum (specific micronutrient composition with omega-3 fatty acids) group or placebo
      group. Both groups were encouraged to consume a self-directed well-balanced variety of
      nutrient-dense foods.

      All women participated in an exercise program (fitness walking) on 1-2 days per week during
      all three phases of the study for a total of 12 months.
    

Intervention name(s): Meal replacement (MR); Control (C); Verum; Placebo
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Other
Intervention description(s): MR-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d and was advised to replace two meals, i.e. breakfast and dinner, every day with two MR shakes, soups or bars and to prepare their own lunch during 3-month weight loss phase (phase 1).
During 3-month weight stabilization phase (phase 2) MR-S group (MR group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The MR-S group was instructed to continue the implemented nutrition advice of weight loss phase.
Duration: 6 months (phase 1 and phase 2: baseline I - 6.month); During 3-month weight loss phase (phase 1) C-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d without MR for weight control.
During 3-month weight stabilization (phase 2) phase C-S group (C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The C-S group was instructed to continue the implemented nutrition advice of weight loss phase.
Duration: 6 months (phase 1 and phase 2: baseline I - 6.month); Verum: Specific micronutrient composition with omega-3 fatty acids (capsules)
Verum group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 verum-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase (phase 3).
Duration: 6 months (6.month / baseline II - 12.month); Placebo group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 placebo-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase.
Placebo contains no micronutrients and omega-3 fatty acids.
Duration: 6 months (6.month / baseline II - 12.month)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 parallel arms in weight loss phase and weight stabilization phase (1. randomization at baseline I); 2 parallel arms in weight maintanance phase (2. randomization at baseline II)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Management Programs; Weight loss stabilization; Cardiometabolic risk