Evaluation of a Commercial Program on Weight Loss and Health Outcomes 2

University of Pittsburgh1 site in 1 country150 target enrollmentFebruary 15, 2017

ConditionsWeight Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Weight Loss
Sponsor: University of Pittsburgh
Enrollment: 150
Locations: 1
Primary Endpoint: Body Weight Change
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially available weight loss program, on changes in body weight. The current investigation aims to add to this body of evidence by providing additional data on changes in body weight and enhance the current evidence-base in regards to evaluating other health-related outcomes.

There is little evidence that demonstrates whether or not the weight loss as a result of the Weight Watchers program elicits changes in health-related functional outcomes such as aerobic capacity, flexibility, sleep, and other psychological measures. Additionally, within a scientific research protocol, measures of adherence and satisfaction will also be evaluated evaluated. This study will evaluate these outcomes beyond weight changes achieved across the 24-week program.

Registry

clinicaltrials.gov

Start Date

February 15, 2017

End Date

September 18, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Principal Investigator

Renee J. Rogers

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

•Male or female ages 18-75 years. Set "soft quotas" on the number of male and female participants. The desire is to have an 80% female/20% male split.
•Willing to enroll in the Weight Watchers Program
•With or without previous Weight Watchers experience Set maximum quota on the number of participants with previous Weight Watchers experience at 65%.
•Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 43 (will re-screen at facility).
•Self report that he/she feels the need to lose weight.
•Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement.
•Willing to follow recommendations required by study protocol.
•Willing to include demographic information (e.g., ethnicity, income and education).
•Use of a personal iPhone on a daily basis
•iPhone must have iOS 8.0 or later

Exclusion Criteria

•Currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs such as 5-2, or Atkins) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
•A member of Weight Watchers within the past 12 months.
•Involved in any other related research studies and self-report agreeing to not enroll in other studies that may affect weight or health outcomes over the next 12 months.
•Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
•Weight loss of ≥ 5 kg in the previous 6 months.
•History of clinically diagnosed eating disorder.
•Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
•Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
•Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) for 6 months
•Diuretic use for hypertension over 1.5mg per day