The Effects of a Commercially Available Weight Loss Program on Body Weight in Overweight Men and Women

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.

Conditions

• Overweight and Obesity
• Weight Loss

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• The Center for Applied Health Sciences

  collaborator UNKNOWN

• Omega Statistics

  collaborator UNKNOWN

• Nutrisystem, Inc.

  lead INDUSTRY

Principal Investigators

• Tim N Ziegenfuss, Ph.D., FISSN, CSCS · The Center for Applied Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-08-31

Completion

2016-08-31