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

NCT ID: NCT00831194

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

Brief 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.

Detailed 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.

Conditions

Obesity; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Diet plan and PDA

Group Type: EXPERIMENTAL

Personalized diet plan and PDA self reporting.

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Lawrence J. Cheskin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence J Cheskin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB#00001685

Identifier Type: -

Identifier Source: org_study_id