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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
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus
 Behavioral: Automated Telephone Nutrition Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use Of Automated Telephone Nutrition Support In Spanish-Speaking Latino Patients With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040676

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01040676     History of Changes
Other Study ID Numbers: 121609ATNSUCSF
Study First Received: December 27, 2009
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013