Improving Self-Monitoring in Weight Loss With Technology

NCT00277771 | Completed

• 2 other identifiers: 05070981R01DK071817-01
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

technology in weight loss; standard behavioral therapy for obesity

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Measured every 6 months

Secondary Outcomes (2)

• Adherence to self-monitoring

  Measured throughout the study

• Coronary heart disease risk factors (lipid, glucose, insulin)

  Measures annually

Interventions

Standard behavioral treatment (SBT) for weight loss BEHAVIORAL

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.

SBT for weight loss using a PDA BEHAVIORAL

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.

SBT for weight loss using a PDA with feedback messages BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lora Burke: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• 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.

  PMID: 26609668 DERIVED

• 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.

  PMID: 22936524 DERIVED

• 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.

  PMID: 22704741 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Serum Bactericidal Test

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Study Officials

• Lora E. Burke, PhD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Nursing and Epidemiology

Study Record Dates

• First Submitted: January 13, 2006
• First Posted: January 16, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

US (1)