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Improving Self-Monitoring in Weight Loss With Technology

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ClinicalTrials.gov Identifier: NCT00277771
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : July 7, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lora Burke, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Self-Monitoring in Weight Loss With Technology
Study Start Date : February 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Standard behavioral treatment (SBT) for weight loss
    Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Standard paper diaries are used for self-monitoring.
  • Behavioral: SBT for weight loss using a PDA
    Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants (PDAs) are used for self-monitoring.
  • Behavioral: SBT for weight loss using a PDA with feedback messages
    Participants attend group sessions where they learn about healthy eating and exercise. They are asked to self-monitor all calories consumed (food and drink) and all calories expended through exercise. Personal Digital Assistants with a customized feedback program are used for self-monitoring.


Primary Outcome Measures :
  1. Weight Change [ Time Frame: Measured every 6 months ]

Secondary Outcome Measures :
  1. Adherence to self-monitoring [ Time Frame: Measured throughout the study ]
  2. Coronary heart disease risk factors (lipid, glucose, insulin) [ Time Frame: Measures annually ]


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    • Note that although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277771


Locations
United States, Pennsylvania
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Lora Burke
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Lora E. Burke, PhD, MPH University of Pittsburgh