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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: Personalized diet plan and PDA self reporting.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00831194

IRB#00001685

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 1 patient group

Diet plan and PDA

Experimental group

Treatment:

Behavioral: Personalized diet plan and PDA self reporting.