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

NCT00780468 | Completed

• 1 other identifier: HR#18523
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

Weight loss; Diet; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in bodyweight.

  12 weeks

Secondary Outcomes (1)

• Changes in waist circumference, blood pressure, lipids, questionnaire measures

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Existing diet plan

Behavioral: Existing diet plan

2

EXPERIMENTAL

New diet plan

Behavioral: New diet plan

Interventions

Existing diet plan BEHAVIORAL

1

New diet plan BEHAVIORAL

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• WW International Inc: collaborator

Study Sites (1)

Medical University of South Carolina Weight Management Center

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 24411753 DERIVED

• 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.

  PMID: 23121787 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick M. O'Neil, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 27, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (1)