Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes - Full Text View

Sponsored by:	Johns Hopkins Bloomberg School of Public Health
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00831194

Purpose

It is a 6.5 months clinical trial to examine the relationship between self reported stress, an objective biochemical indicator of stress in saliva named salivary alpha amylase and self reported dietary lapse among type 2 diabetic adults who are interested in weight loss.

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

MedlinePlus related topics: Diabetes Diets Obesity Weight Control

U.S. FDA Resources

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

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

Primary Outcome Measures:

Positive correlation between self reported stress and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Positive correlation 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 correlation between: 1. Self reported neighborhood crime and weight loss. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	February 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Diet plan and PDA: Experimental	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 face significant stress. They will also be required to collect their own saliva samples for 6 weeks- 3 times/day; for 2 days/week. 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

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

Contacts

Contact: Lawrence J Cheskin, MD	410-583-2860	lcheski1@jhmi.edu
Contact: Michelande Ridore, BA	410-502-3103	mridore@jhsph.edu

Locations

United States, Maryland
Center for Human Nutrition
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:	Johns Hopkins Bloomberg School of Public Health ( Lawrence J. Cheskin )
Study ID Numbers:	IRB#00001685
Study First Received:	January 27, 2009
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00831194 History of Changes
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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Stress
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009