Automated Telephone Nutrition Support (ATNS)

June 22, 2012 updated by: University of California, San Francisco

The Use Of Automated Telephone Nutrition Support In Spanish-Speaking Latino Patients With Diabetes

The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in Oakland.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Automated Telephone Nutrition Support (ATNS) study is a joint effort between the University of California at San Francisco, La Clinica de la Raza, and patients living with diabetes in Fruitvale (Oakland). Our goal is to see if motivated people with diabetes are able to get their blood sugar under better control by choosing a healthier diet. Since it's hard to eat a healthy diet, one of the ways we are trying to help is by calling people, having them record what they've eaten, and reminding them of the right foods to eat. The innovative part is using an automated telephone system to call them to have them record their dietary choices and giving them feedback immediately regarding what to modify as appropriate.

Study Type

Interventional

Enrollment (Actual)

75

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
      • Oakland, California, United States, 94623
        • La Clinica de la Raza

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18.
  • Diabetic with A1c >8.5 for at least 1 year based on clinic records.
  • Spanish-speaking (self-defined)

Exclusion Criteria:

  • No telephone at home
  • Planning to be out of town for longer than 2 weeks in the coming 12 weeks and thus unable to take part in follow up
  • Pregnancy
  • Insulin-dependent Diabetes
  • Any evidence of end organ damage including chronic kidney disease requiring dialysis, congestive heart failure, or cirrhosis.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients in this (the control group) will be eligible to receive the intervention (see "Intervention Group") after 12 weeks (essentially when the trial is over).
Experimental: Intervention Group
Patients in the intervention group will receive automated telephone calls at regular intervals twice a week. The system will be programmed to call them at these intervals until contact. The ATNS system will solicit information from them in a culture specific manner, inquiring as to what foods they are eating each meal, each day, and each month. The ATNS system will then make proactive suggestions regarding low glycemic index foods, giving encouragement and feedback as appropriate.
Behavioral: Automated Telephone Nutrition Support
See Intervention Group description.
Other Names:
  • ATNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 12 weeks
12 weeks
Blood Pressure
Time Frame: 12 weeks
12 weeks
Body Mass Index
Time Frame: 12 weeks
12 weeks
Low Density Lipoprotein-calculated (LDL-c)
Time Frame: 12 weeks
12 weeks
C-reactive Protein
Time Frame: 12 weeks
12 weeks
Waist Circumference
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ralph Gonzales, MD, MSPH, University of California, San Francisco

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

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 27, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (Estimate)

December 29, 2009

Study Record Updates

Last Update Posted (Estimate)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121609ATNSUCSF

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.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Automated Telephone Nutrition Support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe