Automated Telephone Nutrition Support (ATNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040676
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Automated Telephone Nutrition Support Not Applicable

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  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use Of Automated Telephone Nutrition Support In Spanish-Speaking Latino Patients With Diabetes
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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 Name: ATNS

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Weight [ Time Frame: 12 weeks ]
  2. Body Mass Index [ Time Frame: 12 weeks ]
  3. Blood Pressure [ Time Frame: 12 weeks ]
  4. Low Density Lipoprotein-calculated (LDL-c) [ Time Frame: 12 weeks ]
  5. C-reactive Protein [ Time Frame: 12 weeks ]
  6. Waist Circumference [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040676

United States, California
La Clinica de la Raza
Oakland, California, United States, 94623
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Ralph Gonzales, MD, MSPH University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01040676     History of Changes
Other Study ID Numbers: 121609ATNSUCSF
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by University of California, San Francisco:
Diabetes Mellitus
Nutrition Support
Low English Proficiency

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases