The Effects of a Commercially Available Weight Loss Program on Body Weight in Overweight Men and Women
Condition: Overweight and Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The primary purpose of this study (Part A) is to assess changes in body weight and body
      circumference parameters that are achievable after 4 weeks on the Nutrisystem program
      compared to a self-directed diet (i.e. Dietary Approaches to Stop Hypertension or DASH). In
      Part B, subjects on the Nutrisystem program will be given the option to continue the program
      for another 8 weeks.
    

Detailed description: 
      A randomized, controlled, parallel study design with two parts (Part A and Part B). Study
      visits include Screening, Randomization, and Weeks 1, 2, 3 and 4. Week 4 serves also as the
      closeout study visit for Part A. Subjects randomized to the intervention group (i.e.,
      Nutrisystem group) will continue the program for an additional 8 weeks, and include
      additional study visits at week 8 and 12.

      Eighty-four (N=84) healthy men and women, matched paired for BMI, will be randomized into one
      of two groups for 28 days (4 weeks): Nutrisystem program or a self-directed Dietary
      Approaches to Stop Hypertension ("DASH"). All subjects in the Nutrisystem group who complete
      Part A will continue on the Nutrisystem program for an additional 8 weeks (Part B).

      Daily energy intake targets for each group will include a 1000 kcal/day diet for both women
      and men during the first week. After the first week women will follow a 1200 kcal/day diet
      and men will follow a 1500 kcal/day diet. Subjects with BMI > 40 will add approximately 200
      additional calories to their diet each day.

      Body weight and body circumference (Waist, Hip, Chest, Arm & Thigh and Sum of the 5) measures
      were obtained at baseline and weeks 1, 2, 3, 4 (Part A). And at weeks 8 and 12 for the
      Nutrisystem group (Part B).
    

Intervention name(s): Nutrisystem; Self-Directed DASH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Nutrisystem Diet was 1000 kcal/day for week 1,and 1200 calories/day for women and 1500 calories/day for men after week 1.Subjects with BMI > 40 added 200 extra calories/day through grocery food add-ins.Subjects received 7 breakfast,7 lunches,7 dinners, and 14 shakes for week 1.Subjects added in vegetables & no-calorie beverages in week 1.After week 1,Nutrisystem provided 7 breakfasts,6 lunches,6 dinners, and 7 (women) or 14 (men) snacks/week.Subjects prepared 1 lunch & 1 dinner on their own weekly. Guidelines were given to allow subjects to select foods that fit within plan guidelines (~50% kcal from carbohydrate,~25% from protein,~25% from fat). Nutrisystem foods were about 60% of kcal target; grocery additions made the balance.Subjects received guidance as typical on Nutrisystem throughout the study period.Subjects were encouraged to call Nutrisystem counselors. Subjects randomized to this participated in Part A (4 weeks) and Part B (additional 8 weeks) of the study.; The self-directed Dietary Approaches to Stop Hypertension group received instruction/education with handouts & sample meal plans, which met guidelines for DASH. All subjects followed a 1000 kcal/day DASH diet for week 1. After week 1, women ate 1200 kcal/day & men ate 1500 kcal/day. Subjects with BMI >40 added an extra 200 kcal/day. Subjects randomized to this group received one additional educational session beyond the Randomization visit on how to follow their prescribed meal plan. Subjects in this group only participated in Part A (4-weeks) of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Obesity; Overweight