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

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized diet plan and PDA self reporting.
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Type 2 Diabetes, Obesity, Weight loss, PDA, Stress, Dietary lapse, salivary alpha amylase

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diet plan and PDA

Arm Description

Outcomes

Primary Outcome Measures

Self reported stress, weight loss, and salivary alpha amylase.

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.

Full Information

First Posted
January 27, 2009
Last Updated
July 31, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00831194
Brief Title
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
Official Title
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Type 2 Diabetes, Obesity, Weight loss, PDA, Stress, Dietary lapse, salivary alpha amylase

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet plan and PDA
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Personalized diet plan and PDA self reporting.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self reported stress, weight loss, and salivary alpha amylase.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Cheskin, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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

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