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

NCT00831194 | Completed

• 1 other identifier: IRB#00001685
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes

Keywords

Type 2 Diabetes; Obesity; Weight loss; PDA; Stress; Dietary lapse; salivary alpha amylase

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• Positive correlation between levels of salivary alpha amylase (sAA) and weight loss, BMI and levels of sAA, levels of sAA and maladaptive coping.

  1 year

Study Arms (1)

Diet plan and PDA

EXPERIMENTAL

Behavioral: Personalized diet plan and PDA self reporting.

Interventions

Personalized diet plan and PDA self reporting. BEHAVIORAL

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.

Diet plan and PDA

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

US (1)