84
Participants
Start Date
January 31, 2016
Primary Completion Date
August 31, 2016
Study Completion Date
August 31, 2016
Nutrisystem
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.
Self-Directed DASH
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.
The Center for Applied Health Sciences
UNKNOWN
Omega Statistics
UNKNOWN
Nutrisystem, Inc.
INDUSTRY