Clinical Trials Directory

Trials / Completed

CompletedNCT02520050

The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM

The Effect of Three Different Models of Medical Nutrition Therapy (MNT) on Diabetes Control in Overweight and Obese Patients With Type 2 Diabetes: A Randomized Comparative Study. (Nutrition Path Study)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
Joslin Diabetes Center · Academic / Other
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The American Diabetes Association (ADA), among other medical societies, is strongly recommending medical nutrition therapy (MNT) for prevention and management of type 2 diabetes. However, the ADA recognized that there is no "one size fits all" diet and thus recommends that MNT should be conducted through a consultation with registered dietitians (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an integral part of the MNT, lowers postprandial blood glucose levels. Through our experience from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying MNT within a structured dietary intervention protocol has the best impact on blood glucose values and body weight. Meanwhile, the frequent use of health coaching during dietary intervention proved to be effective in managing diabetes and inducing weight loss. However, no study compared those three intervention methods in a randomized clinical study. The aim of this study is to evaluate the effect of different models of conducting medical nutrition therapy on the glycemic control in patients with type 2 diabetes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTraditional MNTWill follow the nutritional recommendations set by the American Diabetes Association in 2013.
BEHAVIORALStructured MNTWill follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.
BEHAVIORALStructured MNT plus Weekly SupportWill follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula; in addition to receiving weekly coaching from a registered dietitian

Timeline

Start date
2015-04-01
Primary completion
2018-07-01
Completion
2018-07-01
First posted
2015-08-11
Last updated
2019-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02520050. Inclusion in this directory is not an endorsement.