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	Behavior: Standard behavioral treatment (SBT) for weight loss  Behavior: SBT for weight loss using a PDA  Behavior: SBT for weight loss using a PDA with feedback messages

Further study details as provided by University of Pittsburgh:

Primary Outcomes: Weight Change
Secondary Outcomes: Adherence to self-monitoring; Coronary heart disease risk factors (lipid, glucose, insulin, and C-reactive protein levels)
Expected Total Enrollment:  198

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.

Ages Eligible for Study:  18 Years   -   59 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. age 18 to 59 years
2. BMI ≥ 27 and ≤ 43
3. willing to be randomized to one of the three treatment conditions
4. successful completion of screening

Exclusion Criteria:

1. presence of an eating disorder
2. current serious illness or unstable condition requiring physician-supervised diet and exercise including a glucose level above 125 at baseline
3. physical limitations precluding ability to exercise
4. pregnant or planning to become pregnant in the next 24 mos
5. under current treatment for a psychological disorder
6. reported alcohol intake of 4 drinks/day or more
7. current or recent (past 6 mos) participation in a weight-loss program or use of weight-loss medication
8. planning an extended vacation, absence, or relocation within the next 24 mos

Please refer to this study by ClinicalTrials.gov identifier  NCT00277771

Lora E. Burke, PhD, MPH      412-624-2305    lbu100@pitt.edu
Mindi A. Styn, PhD-C      412-624-0966    mimst31@pitt.edu

Pennsylvania
      University of Pittsburgh School of Nursing, Pittsburgh,  Pennsylvania,  15261,  United States

Study chairs or principal investigators

Lora E. Burke, PhD, MPH,  Principal Investigator,  University of Pittsburgh   

Study ID Numbers:  0507098; 1R01DK071817-01
Last Updated:  January 13, 2006
Record first received:  January 13, 2006
ClinicalTrials.gov Identifier:  NCT00277771
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-17