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| Sponsors and Collaborators: |
University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00277771 |
Purpose
We propose to conduct a randomized study of standard behavioral weight-loss treatment to test if using an electronic diary with or without tailored feedback will improve adherence to self-monitoring and subsequently improve weight loss. Subjects will be randomly assigned to different methods to self-monitor food and exercise habits: (1) use of the traditional paper diary , (2) use of a personal digital assistant (PDA), or (3) use of a personal digital assistant that also provides daily feedback.
| Condition | Intervention |
|---|---|
|
Obesity Overweight |
Behavioral: Standard behavioral treatment (SBT) for weight loss Behavioral: SBT for weight loss using a PDA Behavioral: SBT for weight loss using a PDA with feedback messages |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment |
| Official Title: | Improving Self-Monitoring in Weight Loss With Technology |
| Estimated Enrollment: | 198 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
The prevalence of obesity, a major chronic health problem that is an independent risk factor for coronary heart disease (CHD), continues to increase at an alarming rate. Although weight control research has significantly improved short-term treatment success, long-term weight loss maintenance has lagged behind. Research has demonstrated a consistent relationship between self-monitoring eating and physical activity habits and success in weight loss as well as in maintenance of weight loss. However, the methods primarily used for self-monitoring continue to be the paper diary (PD), which is time consuming and burdensome. Moreover, PDs do not permit immediate external feedback to support and motivate the individual. Emerging technologies could improve self-monitoring and weight loss treatment. However, the use of these technological advances, such as a personal digital assistant (PDA), has not been studied in weight loss treatment. The primary aim of this behavioral weight loss treatment study is to determine if self-monitoring of daily eating and physical activity habits using a PDA, with or without a tailored feedback intervention, is superior to using a PD in terms of promoting and maintaining short- and long-term weight loss. Secondary aims include comparing the effect of treatment group assignment on adherence to self-monitoring and on risk factors for CHD (lipids, glucose, insulin, C-reactive protein). We propose to enroll 198 subjects and randomize them to one of three treatment groups that will use different methods to self-monitor eating and physical activity habits: (1) use of the traditional PD with delayed written feedback, (2) use of a PDA with limited feedback on daily targets, or (3) use of a PDA with limited feedback on daily targets plus receive daily, subject-tailored feedback messages via the PDA. The proposed study includes prolonged (24 months) supervision of self-management with three important components: self-monitoring, feedback, and ongoing contact. Subjects will complete assessments at baseline, 6, 12, 18, and 24 months. This innovative study will provide information on the efficacy of combining technological advances with proven behavioral strategies.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
successful completion of screening
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh School of Nursing | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Principal Investigator: | Lora E. Burke, PhD, MPH | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh School of Nursing ( Lora E. Burke, PhD, MPH, FAAN ) |
| Study ID Numbers: | 0507098, 1R01DK071817-01 |
| Study First Received: | January 13, 2006 |
| Last Updated: | May 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00277771 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
technology in weight loss standard behavioral therapy for obesity |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |