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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Existing diet plan
New diet plan
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight loss, Diet, Obesity

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina Weight Management Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Existing diet plan

New diet plan

Outcomes

Primary Outcome Measures

Change in bodyweight.

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2008
Last Updated
March 26, 2014
Sponsor
Medical University of South Carolina
Collaborators
Weight Watchers International
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1. Study Identification

Unique Protocol Identification Number
NCT00780468
Brief Title
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Official Title
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Weight Watchers International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Weight loss, Diet, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Existing diet plan
Arm Title
2
Arm Type
Experimental
Arm Description
New diet plan
Intervention Type
Behavioral
Intervention Name(s)
Existing diet plan
Intervention Type
Behavioral
Intervention Name(s)
New diet plan
Primary Outcome Measure Information:
Title
Change in bodyweight.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in waist circumference, blood pressure, lipids, questionnaire measures
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick M. O'Neil, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina Weight Management Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24411753
Citation
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.
Results Reference
derived
PubMed Identifier
23121787
Citation
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.
Results Reference
derived

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

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