Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2009 | ||||
| Last Updated Date | July 31, 2012 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Self reported stress, weight loss, and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Positive corelation between self reported stress and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00831194 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes | ||||
| Official Title ICMJE | Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Diet plan and PDA
Intervention: Behavioral: Personalized diet plan and PDA self reporting. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00831194 | ||||
| Other Study ID Numbers ICMJE | IRB#00001685 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lawrence J. Cheskin, Johns Hopkins Bloomberg School of Public Health | ||||
| Study Sponsor ICMJE | Johns Hopkins Bloomberg School of Public Health | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins Bloomberg School of Public Health | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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