The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

NCT01260337 | Completed

• 1 other identifier: 12987
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study to find out whether a pre-packaged, portion controlled diet with a group behavior modification program or group diabetes support and education, is a safe and effective way for people with type 2 diabetes to lose weight and manage their diabetes.

Conditions

Obesity

Keywords

Weight loss; Type 2 Diabetes; Behavior Modification; portion control

Outcome Measures

Primary Outcomes (1)

• Change in weight at 3 and 6 months

  Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.

  Baseline, 3 & 6 months

Secondary Outcomes (1)

• Change in HbA1C at 3 and 6 months

  Baseline, 3 & 6 Month

Study Arms (2)

Diabetes Support and Education (DSE)

ACTIVE COMPARATOR

Other: Diabetes Support and Education

Portion controlled diet (PCD)

EXPERIMENTAL

behavior modification

Behavioral: Portion controlled diet

Interventions

Portion controlled diet BEHAVIORAL

Participants learn skills for changing nutritional and lifestyle habits and diabetes management follow a program that includes eating a pre-packaged, portion controlled meal for weight loss in addition to attending the behavior modification groups

Also known as: PCD

Portion controlled diet (PCD)

Diabetes Support and Education OTHER

The DSE groups will consist of educational sessions offered for diabetes support and education which will include sessions on diet/nutrition, exercise, foot care and living with diabetes.

Also known as: DSE

Diabetes Support and Education (DSE)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
• BMI ≥ 25 and ≤ 50
• Subjects must be willing to comply with all study-related procedures
• Participant with screening HbA1C ≥ 6.5 and \<12.0.

You may not qualify if:

• BMI ≤24.9 or ≥ 50.1
• Participation in another formal weight loss program within last 6 months
• Weight loss \> 5 kg during the last 6 months
• Participation in Diabetes Support and Education Program or other formal diabetes education program within last 6 months
• Uncontrolled hypertension (systolic blood pressure \> 180 or diastolic blood pressure \> 100 mmHg). Participants on medication treating hypertension for at least three months are allowable.
• Known atherosclerotic cardiovascular disease
• History of congestive heart failure
• History of a non-skin malignancy within the previous 5 years
• Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
• History of testing HIV positive
• History of alcohol or drug abuse
• Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
• Participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
• Participants with screening triglycerides above 500 mg

Sponsors & Collaborators

• Temple University: lead
• Nutrisystem, Inc.: collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

University of Pennsylvania, Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University, The Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

• Foster GD, Borradaile KE, Vander Veur SS, Leh Shantz K, Dilks RJ, Goldbacher EM, Oliver TL, Lagrotte CA, Homko C, Satz W. The effects of a commercially available weight loss program among obese patients with type 2 diabetes: a randomized study. Postgrad Med. 2009 Sep;121(5):113-8. doi: 10.3810/pgm.2009.09.2046.

  PMID: 19820280 BACKGROUND

Related Links

• Center for Weight and Eating Disorders

MeSH Terms

Conditions

Obesity; Weight Loss; Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Gary D Foster, PhD

  Temple University, Center for Obesity Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: December 15, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 1, 2013

Record last verified: 2010-09

Locations

US (2)