A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population

November 13, 2012 updated by: University of Southern California

The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population

Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.

Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.

Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.

Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.

Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90022
        • Roybal Diabetes Management Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Demographic

  • Age >18 years
  • Enrolled in the Roybal Diabetes Management Clinic
  • Self-described as Hispanic
  • Willing and able to participate in Spanish language group sessions.
  • Willing and able to attend study visits for the duration of the study at the allocated times.
  • Willing and able to maintain a food exercise and medication log and perform and record self-monitoring of blood glucose (SMBG) Clinical
  • T2DM diagnosed by fasting blood glucose >126mg/dL or random blood glucose >200mg/dL
  • BMI>30 kg/m2
  • If a woman of childbearing potential, using effective contraception. Biochemical HbA1c 8%-12% Medication
  • On insulin therapy

Exclusion Criteria:

Medical conditions

  • Type 1 DM
  • Illness likely to lead to unstable weight or altered glucose control.
  • Proliferative diabetic retinopathy on eye examination within the last 6 months.
  • Gallstones suspected on clinical history or documented on ultrasound.
  • Serum creatinine >1.5mg/dL
  • Symptomatic cardiovascular disease
  • Documented liver disease other than fatty liver
  • Lactating, pregnant or intending to become pregnant within the following year Psycho-social conditions
  • Inability or unwillingness to participate in a Spanish-language lifestyle group.
  • Eating disorder such as bulimia
  • Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar disorder.
  • Inability to attend scheduled appointments regularly for the duration of the study Medication use
  • Use of weight loss medication within previous 3 months including exenatide.
  • Use of medication (other than diabetes medication) likely to lead to unstable weight or altered glucose control
  • Laxative or substance abuse
  • More than 10 alcoholic drinks/week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Meal Replacement
Meal Replacements will be provided to participants randomized to the MR group
Other: Meal Replacement
5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
Other Names:
  • HMR70 Plus products; HMR Boston, Massachusetts
Other: Standard Care
Standard Care participants will receive standard care but no meal replacements
Other: Standard Care
Standard Care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in BMI
Time Frame: 12months
12months

Secondary Outcome Measures

Outcome Measure
Time Frame
Severe Hypoglycemic Events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Elizabeth O Beale, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-08-00646

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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