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Automated Telephone Nutrition Support (ATNS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040676
First received: December 27, 2009
Last updated: June 22, 2012
Last verified: June 2012

December 27, 2009
June 22, 2012
February 2010
January 2012   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01040676 on ClinicalTrials.gov Archive Site
  • Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Low Density Lipoprotein-calculated (LDL-c) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • C-reactive Protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Automated Telephone Nutrition Support
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
Behavioral: Automated Telephone Nutrition Support
See Intervention Group description.
Other Name: ATNS
  • 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.
    Intervention: Behavioral: Automated Telephone Nutrition Support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01040676
121609ATNSUCSF
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Ralph Gonzales, MD, MSPH University of California, San Francisco
University of California, San Francisco
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP