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

Overweight and Obesity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03070015
Study type Interventional
Source Nutrisystem, Inc.
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date August 2016
View Details
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