Automated Telephone Nutrition Support
ATNS
The Use Of Automated Telephone Nutrition Support In Spanish-Speaking Latino Patients With Diabetes
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Feb 2010
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2009
CompletedFirst Posted
Study publicly available on registry
December 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 26, 2012
June 1, 2012
1.9 years
December 27, 2009
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
12 weeks
Secondary Outcomes (6)
Weight
12 weeks
Body Mass Index
12 weeks
Blood Pressure
12 weeks
Low Density Lipoprotein-calculated (LDL-c)
12 weeks
C-reactive Protein
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONPatients in this (the control group) will be eligible to receive the intervention (see "Intervention Group") after 12 weeks (essentially when the trial is over).
Intervention Group
EXPERIMENTALPatients 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.
Interventions
See Intervention Group description.
Eligibility Criteria
You may qualify if:
- Age \>18.
- Diabetic with A1c \>8.5 for at least 1 year based on clinic records.
- Spanish-speaking (self-defined)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
La Clinica de la Raza
Oakland, California, 94623, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Gonzales, MD, MSPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2009
First Posted
December 29, 2009
Study Start
February 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-06