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Improving Self-Monitoring in Weight Loss With Technology

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00277771
First received: January 13, 2006
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Self-Monitoring in Weight Loss With Technology

Resource links provided by NLM:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Weight Change [ Time Frame: Measured every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to self-monitoring [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Coronary heart disease risk factors (lipid, glucose, insulin) [ Time Frame: Measures annually ] [ Designated as safety issue: No ]
Enrollment: 210
Study Start Date: February 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility
Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277771

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

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lora E. Burke, PhD, MPH, FAAN, University of Pittsburgh School of Nursing
ClinicalTrials.gov Identifier: NCT00277771     History of Changes
Other Study ID Numbers: 0507098, 1R01DK071817-01
Study First Received: January 13, 2006
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
technology in weight loss
standard behavioral therapy for obesity

ClinicalTrials.gov processed this record on February 27, 2015