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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lawrence J. Cheskin, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00831194
First received: January 27, 2009
Last updated: July 31, 2012
Last verified: July 2012

January 27, 2009
July 31, 2012
March 2009
July 2010   (final data collection date for primary outcome measure)
Self reported stress, weight loss, and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Positive corelation between self reported stress and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00831194 on ClinicalTrials.gov Archive Site
Positive correlation between levels of salivary alpha amylase (sAA) and weight loss, BMI and levels of sAA, levels of sAA and maladaptive coping. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Positive corelation between: 1. Levels of salivary alpha amylase (sAA) and weight loss, 2. BMI and levels of sAA, 3. levels of sAA and maladaptive coping. Negative corelation between: 1. Self reported neighborhood crime and weight loss. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Obesity
  • Type 2 Diabetes
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.
Experimental: Diet plan and PDA
Intervention: Behavioral: Personalized diet plan and PDA self reporting.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2012
July 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831194
IRB#00001685
No
Lawrence J. Cheskin, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: Lawrence J Cheskin, MD Johns Hopkins School of Public Health
Johns Hopkins Bloomberg School of Public Health
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP