A Trial of the Ideal Protein System Versus Low Fat Diet for Weight Loss
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study will examine whether, compared to a standard, low-fat, calorie-restricted diet
      intervention, the clinic-supported Ideal Protein weight loss method will result in greater
      weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults
      with cardiovascular disease (CVD) risk factors.
    

Detailed description: 
      Restricting total calorie intake is emphasized in the 2013 American Heart Association/
      American College of Cardiology/ The Obesity Society Guideline (AHA/ACC/TOS) for the
      Management of Overweight and Obesity in Adults for its effectiveness at reducing body weight
      and decreasing cardiometabolic risk factors. An implication of this focus on total quantity
      of calories consumed is that macronutrient composition of dietary intake and its effects on
      the hormonal milieu that regulates adipose accumulation in the human body do not play a
      significant role in weight loss. Such recommendations and the results of limited previous
      studies have led to the advice that all weight loss diets regardless of macronutrient
      composition will produce the same degree of weight loss if adherence to the diet is similar.
      In contrast, our previous studies have shown that despite comparable adherence to dietary
      goals, participants losing weight on a moderately carbohydrate-restricted, adequate protein
      regimen have improved cardiometabolic indicators as compared to those restricting fat. The
      RENEWAL trial will provide unique data on the efficacy of the Ideal Protein method (moderate
      carbohydrate restriction and adequate protein) for weight loss and improvement in
      cardiometabolic risk factors. The interventions will include a significant proportion of
      African-Americans, a group with very high rates of obesity which is often under-represented
      in trials examining the effects of weight loss diets. Findings from this trial may offer new
      evidence for the recommendation of specific macronutrient and behavioral approaches to the
      reduction of cardiometabolic risk factors.
    

Intervention name(s): Ideal Protein Weight Loss Method; Standard Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An initial visit will take place in which each participant assigned to the experimental group will complete a health profile questionnaire.The Ideal Protein method will be explained and the participant will be weighed, measured and given diet related informational materials. A staff member will assist the participant with the selection of foods and snacks to ensure adequate quantity for the week. Weekly follow-up visits of 15 minutes duration will be implemented with a telephone follow-up occurring during the first 4 days after the initial appointment.
For 12 weeks Ideal Protein foods that are of the appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).; This arm utilizes evidence-based strategies that have been shown to be effective for long-term weight loss and weight loss maintenance (including behavioral techniques, diet modification, and social support) consistent with the 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Participants in this arm will have an initial one hour consultation with a trained interventionist, where the fat goal and calorie restriction goal are explained.
For 12 weeks low-fat reduced calorie foods that are of appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants (n=192) with BMI ≥30 and ≤49 will be randomized to one of two parallel study arms: Group A: Ideal Protein Weight Loss Intervention; Group B: Standard Low-Fat, Low-Calorie, Guideline-based Weight Loss Intervention. Participants will undergo baseline testing, and if eligible, will be randomly assigned to study group, undergo three months of their assigned study intervention, and clinical testing at baseline, 6, and 12 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Other