Improving Self-Monitoring in Weight Loss With Technology

Tracking Information
First Submitted Date ICMJE	January 13, 2006
First Posted Date ICMJE	January 16, 2006
Last Update Posted Date	July 7, 2015
Study Start Date ICMJE	February 2006
Actual Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 12, 2007)	Weight Change [ Time Frame: Measured every 6 months ]
Original Primary Outcome Measures ICMJE; (submitted: January 13, 2006)	Weight Change
Change History	Complete list of historical versions of study NCT00277771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 12, 2007)	Adherence to self-monitoring [ Time Frame: Measured throughout the study ]; Coronary heart disease risk factors (lipid, glucose, insulin) [ Time Frame: Measures annually ]
Original Secondary Outcome Measures ICMJE; (submitted: January 13, 2006)	Adherence to self-monitoring; Coronary heart disease risk factors (lipid, glucose, insulin, and C-reactive protein levels)
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Improving Self-Monitoring in Weight Loss With Technology
Official Title ICMJE	Improving Self-Monitoring in Weight Loss With Technology
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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Obesity; Overweight
Intervention ICMJE	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.
Study Arms	Not Provided
Publications *	Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.; Turk MW, Elci OU, Wang J, Sereika SM, Ewing LJ, Acharya SD, Glanz K, Burke LE. Self-monitoring as a mediator of weight loss in the SMART randomized clinical trial. Int J Behav Med. 2013 Dec;20(4):556-61. doi: 10.1007/s12529-012-9259-9.; Burke LE, Styn MA, Sereika SM, Conroy MB, Ye L, Glanz K, Sevick MA, Ewing LJ. Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial. Am J Prev Med. 2012 Jul;43(1):20-6. doi: 10.1016/j.amepre.2012.03.016.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 30, 2010)	210
Original Enrollment ICMJE; (submitted: January 13, 2006)	198
Actual Study Completion Date	June 2010
Actual Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: age 18 to 59 years; BMI ≥ 27 and ≤ 43; willing to be randomized to one of the three treatment conditions; 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: presence of an eating disorder; current serious illness or unstable condition requiring physician-supervised diet and exercise including a glucose level above 125 at baseline; physical limitations precluding ability to exercise; pregnant or planning to become pregnant in the next 24 mos; under current treatment for a psychological disorder; reported alcohol intake of 4 drinks/day or more; current or recent (past 6 mos) participation in a weight-loss program or use of weight-loss medication; planning an extended vacation, absence, or relocation within the next 24 mos
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 59 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00277771
Other Study ID Numbers ICMJE	0507098; 1R01DK071817-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lora Burke, University of Pittsburgh
Study Sponsor ICMJE	Lora Burke
Collaborators ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators ICMJE	Principal Investigator: Lora E. Burke, PhD, MPH University of Pittsburgh
PRS Account	University of Pittsburgh
Verification Date	July 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP