The Effect of Nutrisystem Meal Provision on Weight

NCT01252303 | Completed

• 1 other identifier: 10-0639-F3R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to determine the effect of a behavioral weight loss program supplemented with Nutrisystem meal replacements on weight, blood pressure, fasting blood glucose, and blood lipids levels over 12 weeks.

Conditions

Obesity

Keywords

Obesity, weight loss, meal replacements

Outcome Measures

Primary Outcomes (1)

• weight change

  Amount of weight lost in the 12 week study.

  12 weeks

Secondary Outcomes (3)

• Blood pressure

  12 weeks

• Fasting Blood Glucose

  12 weeks

• blood lipids

  12 weeks

Study Arms (2)

Nutrisystem

EXPERIMENTAL

Group will receive Nutrisystem meals in addition to the behavioral weight loss program.

Behavioral: Nutrisystem

Control

ACTIVE COMPARATOR

Group will receive a behavioral weight loss program only.

Behavioral: Nutrisystem

Interventions

Nutrisystem BEHAVIORAL

Nutrisystem meal replacements for 12 weeks

Also known as: Weight loss trial

Control; Nutrisystem

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must (1) be age 25 to 65 years old; (2) have a BMI of \> 30 and \<45; (3) own a home computer with access to the Internet.

You may not qualify if:

• Participants must not: (1) have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise; (2) endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells; (3) endorse any of the other items on the PAR-Q without a physician's consent; (4) have had a hospitalization for a psychiatric disorder within the last year; (5) have a history of anorexia or bulimia nervosa; (6) have a medical diagnosis of cancer or HIV with the exception of skin cancer; (7) have a diagnosis with a major psychiatric disorder (i.e. bipolar disorder or schizophrenia); (8) be pregnant, nursing, or planning to become pregnant within the study period; (9) be less than 9 months post-partum; (10) have a recent weight loss of \> 10 pounds; (11) be using centrally-active medications, with the exception of alcohol and caffeine.

Sponsors & Collaborators

• University of Kentucky: lead
• Nutrisystem, Inc.: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506-0054, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Kelly H Webber, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

US (1)