Study to Evaluate Effects of a Weight Loss Program in Different Formats on Healthy Adults

Overweight and Obesity Clinical Trial

Official title: Effects of a Commercially-Available Structured Weight Loss Program Provided in Three Different Formats on Anthropometric Measures in Healthy Overweight and Obese Adults

Status Completed

Clinical Trial Summary

The objective of this study was to determine changes in body weight and related outcomes achievable over a 16-week period in response to three different commercially available weight loss programs (Nutrisystem) providing pre-packed, portion controlled foods and beverages, each compared to a self-directed diet, in apparently healthy overweight and obese men and women.

Clinical Trial Description

A randomized, controlled, four-arm parallel study design included two screening/baseline visits (visits 1 and 2; weeks -1 and 0) and six clinic visits (visits 3, 4, 5, 6, 7, 8, and 9; weeks 1, 2, 3, 4, 8, 12, and 16). One hundred and eighty healthy overweight and obese men and women (18-70 years of age; Body Mass Index 25.00 to 44.99 kg/m2) were randomly assigned (stratified randomization by two BMI and three age categories) to one of four treatment arms: a self-directed diet, or one of three different Nutrisystem programs: 1) My Way; 2) Turbo 10; or 3) a program modeled after the Dietary Approaches to Stopping Hypertension (DASH) diet. Daily energy intake targets for each 16-week intervention were 1500 kcal/day (men) or 1200 kcal/day (women), except for the first week of the Turbo 10 intervention, which included a more aggressive 1000 kcal/day diet to start. Body weight, body circumference (chest, waist, hip, upper arm, thigh and sum of the 5), and blood pressure measurements were obtained at baseline (week 0) and at weeks 1, 2, 3, 4, 8, 12, and 16 in the morning following an overnight fast (9 to 14 hours). Total and regional fat mass and fat-free mass (lean soft tissue and bone) were quantified by dual energy x-ray absorptiometry at baseline (week 0) and at weeks 4, 8, and 16. Analyses of serum lipoprotein lipids were obtained at baseline (week 0), week 8, and week 16. Lipoprotein lipid assessments included Total Cholesterol (TC), LDL-Cholesterol, HDL-Cholesterol, non-HDL-Cholesterol (calculated as TC minus HDL-C), Triglycerides, and the Total Cholesterol/HDL-Cholesterol ratio. Plasma chemistry and whole-blood hematology analyses were conducted at screening (week -1). Questionnaires designed to assess aspects of quality of life and sleep quality were administered at baseline (week 0) and weeks 4, 8, and 16. Quality of Life assessments included the Impact of Weight on Quality of Life-Lite (IQWOL-Lite), 36-Item Short Form Health Survey (SF-36), and Leeds Sleep Evaluation Questionnaire (LSEQ). ;

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity
• Weight Loss

• NCT number: NCT03017443
• Study type: Interventional
• Source: Nutrisystem, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Completion date: October 2015