Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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A clinical trial that uses personal digital assistants (PDAs) to assist in examining the relationship between self reported stress, an objective biochemical indicator of stress (salivary alpha amylase) and self-reported dietary lapse among type 2 diabetic adults who are interested/undergoing in weight loss.

Detailed Description
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In the study, all participants will be provided with a personalized ADA-based diet plan and a pre-programmed PDA. They will be required to record their mood and activities into the PDA whenever PDA prompts, they break their diet plan, and/or and face significant stress. They will also be required to collect saliva samples periodically. In addition to this they will be administered the Trier Social Stress Test once during the study, where they will perform certain stress inducing tasks like delivering a speech and solving maths problems. Salivary samples will be collected before and after these tasks. They will also take various questionnaires during each of the 15 to 16 visits. The completed questionnaires, PDA records and reports of salivary alpha amylase levels will be analyzed to examine the corelation between stress, dietary lapse and weight loss.

Official Title
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Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Personalized diet plan and PDA self reporting.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 to 65 years, seeking weight loss. Type 2 diabetes diagnosis by American Diabetes Association standard criteria. (Confirmed by physician's note or blood glucose reports in previous year or Prescriptions for medications to control blood glucose dated in participant's name within last year). BMI > 30 kg/m2. Exclusion Criteria: Major depression. Cognitive impairment severe enough to preclude informed consent or valid self report. Use of medications that significantly affect appetite. Eating disorder. Inability or unwillingness to use PDA for 6 months. Inability or unwillingness to collect saliva samples.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet plan and PDA<br> | Behavioral: Personalized diet plan and PDA self reporting.<br>* Participants will be given personalized diet plan with a 0.5- 1 lb weight loss/week, based on each person's goals. He/she will also be prompted by a pre programmed PDA to enter dietary lapses and stress inducing events. Saliva samples will be collected as per the study plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported stress, weight loss, and salivary alpha amylase. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive correlation between levels of salivary alpha amylase (sAA) and weight loss, BMI and levels of sAA, levels of sAA and maladaptive coping. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Obesity, Weight loss, PDA, Stress, Dietary lapse, salivary alpha amylase