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OpenTrials
Completed

NCT Number: NCT00831194

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

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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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 28, 2009
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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