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
  Purpose

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.


Condition Intervention
Obesity
Type 2 Diabetes
Behavioral: Personalized diet plan and PDA self reporting.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Self reported stress, weight loss, and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet plan and PDA 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831194

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Lawrence J Cheskin, MD Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Lawrence J. Cheskin, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00831194     History of Changes
Other Study ID Numbers: IRB#00001685
Study First Received: January 27, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Type 2 Diabetes
Obesity
Weight loss
PDA
Stress
Dietary lapse
salivary alpha amylase

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 26, 2014