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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831194
• Other study ID #: IRB#00001685
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: July 31, 2012
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported stress, weight loss, and salivary alpha amylase.		1 year	No
Secondary	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	No