Exercise After Clinically Significant Weight Loss
Condition: Obesity; Sedentary Lifestyle; Insulin Resistance
MeSH terms: Insulin Resistance; Weight Loss
Study type: Interventional

Summary: 
      The Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P) study will
      evaluate the effect of aerobic exercise training amount on weight maintenance following
      clinically significant weight loss.
    

Detailed description: 
      The Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P) study will
      evaluate the effect of aerobic exercise training amount on weight maintenance following
      clinically significant weight loss (CWL). Overweight and obese (BMI: 25-40 kg/m2) men and
      women (18-65 years old) complete an OPTIFAST diet (7%-10% weight loss). Participants that
      obtain CWL will be subsequently randomized to aerobic exercise training consistent with the
      minimum physical activity guidelines (~150 min of moderate intensity exercise) or weight
      maintenance guidelines (200-300 min per wk. at moderate intensity) for 9 additional months.

      Specific Aim 1: To demonstrate the efficacy of the weight loss program in producing CWL and
      retention/adherence of the exercise intervention. Overweight and obese adults (N=39) will
      participate in an OPTIFAST weight loss program and supervised aerobic exercise training (~550
      metabolic equivalents minutes [MET min. per week.]) for 10 weeks. Participants who obtain CWL
      will be subsequently randomized to 16 weeks of aerobic training consistent with the minimum
      physical activity recommendations (~550 MET min per week.) or weight maintenance guidelines
      (~970 MET min per week). The percentage of participants that obtain at least 7% weight loss
      following OPTIFAST treatment, retention rates in the weight loss program, adherence to
      exercise levels, and changes in weight and cardiometabolic risk factors in response to the
      intervention will be evaluated.

      Specific Aim 2: To test the hypothesis that exercise levels consistent with weight
      maintenance recommendations leads to greater weight maintenance after CWL compared to the
      minimum physical activity recommendation levels. Overweight and obese adults (N=30) enrolled
      in VIDANT health's OPTIFAST program and have achieved at least 7% weight loss will be
      randomized to 36 weeks of aerobic exercise training consistent with the minimum public health
      guidelines for physical activity (~550 MET min. per week.) or weight maintenance levels (~970
      MET min per week). The effect of the intervention will be evaluated on weight (primary) as
      well as main secondary measures (e.g. body fat, visceral fat, lipids, lipoprotein particles
      size/class, insulin sensitivity, blood pressure, arterial stiffness, systemic inflammation,
      fitness, and quality of life). The aforementioned cardiometabolic risk factors were selected
      because they can be improved specifically by weight loss and thus may respond differently to
      weight maintenance or regain.
    

Intervention name(s): Physical activity recommendations; Weight maintenance recommendations; OPTIFAST weight loss
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format; Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format; Participants will participant in an OPTIFAST medical weight loss program and exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise training; Insulin resistance; Lipids; Arterial stiffness; Fitness; Weight maintenance; Body composition; Energy expenditure; Weight loss