Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
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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 |
- Self reported stress, weight loss, and salivary alpha amylase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 |
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| United States, Maryland | |
| Johns Hopkins Bloomberg School of Public Health | |
| Baltimore, Maryland, United States, 21205 | |
| 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 October 18, 2012
