Automated Telephone Nutrition Support

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Automated Telephone Nutrition Support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>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<br>* See Intervention Group description.<br>* Other names: ATNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Waist Circumference |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Telephone, Nutrition Support, Automated, Low English Proficiency, Hispanic, Latino