A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format

NCT ID: NCT00780468

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

Brief Summary

This study will provide data on two systems for assigning point values to food choices in a diet plan. The primary purpose of this study is to compare the effectiveness of the two systems with regard to changes in body weight.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Existing diet plan

Group Type: ACTIVE_COMPARATOR

Existing diet plan

Intervention Type: BEHAVIORAL

2

New diet plan

Group Type: EXPERIMENTAL

New diet plan

Intervention Type: BEHAVIORAL

Interventions

Existing diet plan

Intervention Type: BEHAVIORAL

New diet plan

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male or female 25-65 years of age inclusive
• Body Mass Index (BMI) 27.0 -35.0 inclusive.
• Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).
• Not currently taking any over-the-counter weight loss medications or supplement(s).
• Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).
• Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.
• Willing to keep and turn in a daily log/compliance book at the times required by study protocol.
• Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.
• Willingness to make weekly meetings at MUSC.

Exclusion Criteria

• History of thyroid disease, but not taking medication, or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
• Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications
• History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve).
• History of major surgery within three months of enrollment.
• History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
• Presence of implanted cardiac defibrillator or pacemaker.
• Uncontrolled hypertension/high blood pressure.
• Orthopedic limitations that would interfere with ability to engage in regular physical activity.
• Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
• History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
• History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
• Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.
• Participation in another clinical trial within 30 days prior to enrollment.
• Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.
• Taking any psychotropic medicine known to influence weight or weight loss

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WW International Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Lynne Becker

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick M. O'Neil, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina Weight Management Center

Charleston, South Carolina, United States

Countries

United States

References

Milsom VA, Malcolm RJ, Johnson GC, Pechon SM, Gray KM, Miller-Kovach K, Rost SL, O'Neil PM. Changes in cardiovascular risk factors with participation in a 12-week weight loss trial using a commercial format. Eat Behav. 2014 Jan;15(1):68-71. doi: 10.1016/j.eatbeh.2013.10.004. Epub 2013 Oct 21.

Reference Type: DERIVED

PMID: 24411753 (View on PubMed)

O'Neil PM, Theim KR, Boeka A, Johnson G, Miller-Kovach K. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program. Eat Behav. 2012 Dec;13(4):354-60. doi: 10.1016/j.eatbeh.2012.06.002. Epub 2012 Jun 28.

Reference Type: DERIVED

PMID: 23121787 (View on PubMed)

Other Identifiers

HR#18523

Identifier Type: -

Identifier Source: org_study_id