SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings
Open accessAbstract
Background The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial.Methods The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB).Results We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%.Conclusions To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component.
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- Findingown data
Few differences were found between randomized participants and those who completed the second screening stage but were not randomized.
“Few differences were found between the participants who were randomized and those who completed the second stage of screening but were ultimately not randomized.”
Quote in the paperNot a substantial claim - Findingown data
No differences in sociodemographic or baseline measures were evident among the three treatment groups.
“No differences in sociodemographic or baseline measures were evident among the three treatment groups”
Quote in the paperNot a substantial claim - Findingown data
The third cohort had 92% retention at 6 months.
“92% retention at 6 months for the third cohort”
Quote in the paperNot a substantial claim - Findingown data
A total of 210 people were randomized in the SMART trial.
“A total of 210 people were randomized to the SMART trial.”
Quote in the paperNot a substantial claim - Findingown data
At baseline, participants reported consuming a diet that exceeded the calorie and fat gram restrictions of the intervention.
“at baseline participants reported consuming a diet that exceeded the calorie and fat gram restrictions of the intervention”
Quote in the paperNot a substantial claim
- Findingown data
Statistically significant differences were found among cohorts for several baseline measures.
“Statistically significant differences were found among cohorts for several of the baseline measures as displayed in Table 6.”
- Also stated in: § 5. Discussion · hedged
“We also found some statistically significant differences in sociodemographic and physiological variables among the three cohorts at baseline.”
Quote in the paperNot a substantial claim - Also stated in: § 5. Discussion · hedged
- Findingown data
The second cohort had a lower retention rate of 76% at 18 months.
“The second cohort had a lower retention rate of 76% at 18 months.”
Quote in the paperNot a substantial claim - Findingown data
The first cohort had 90% study completion at 24 months.
“We had 90% study completion of the first cohort at 24 months”
Quote in the paperNot a substantial claim - Findingown data
For the first cohort, the 24-month retention rate was 90%.
“At 24 months, retention rate for the first of three cohorts was 90%.”
Quote in the paperNot a substantial claim - Findingnone given
There were 65 individuals who were eligible at initial screening and invited to the Orientation Session but were not randomized.
“There were 65 individuals who were eligible at the initial screening and invited to the Orientation Session but were not randomized.”
Quote in the paperNot a substantial claim - Premisecitation
A previous study by the authors demonstrated that participants often back-fill their diaries, filling them in days after eating and relying on recall.
“We demonstrated in a previous study that participants often back-fill their diaries, e.g. filling in the diary days after the eating behavior occurred and thus needing to rely on recall [24].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Burke, 2008, Using instrumented paper diaries to document self-monitoring patterns in weight loss, Contemporary Clinical Trials source
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- Premisecitation
Another study compared paper diary use in one study to PDA use in a subsequent study and found no difference in weight loss between groups.
“Another study compared paper diary use in one study to the use of a PDA in a subsequent study and also found no difference between the groups in weight loss [47].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [47] Yon, 2007, Personal digital assistants are comparable to traditional diaries for dietary self-monitoring during a weight loss program, J Behav Med source
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- Premisecitation
More consistent self-monitoring is significantly correlated with weekly weight loss.
“Early cross-sectional studies found that more consistent self-monitoring correlated significantly with weekly weight loss [21–23]. More recent studies have confirmed these earlier findings [24,25].”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [21] Baker, 1993, Self-monitoring may be necessary for successful weight control, Behav Ther source
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- cites [22] Baker, 1998, Weight control during the holidays: Highly consistent self-monitoring as a potentially useful coping mechanism, Health Psychol source
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- cites [23] Sperduto, 1986, The effect of target behavior monitoring on weight loss and completion rate in a behavior modification program for weight reduction, Addict Behav source
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- cites [24] Burke, 2008, Using instrumented paper diaries to document self-monitoring patterns in weight loss, Contemporary Clinical Trials source
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- cites [25] Wadden, 2005, Randomized trial of lifestyle modification and pharmacotherapy for obesity, N Engl J Med source
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- Study design and conductreasoning
A final sample size of 156 participants was determined to be required to adequately test the hypotheses.
“Taking these two factors into consideration we determined that a final sample size of 156 participants would be required to adequately test our hypotheses.”
Quote in the paperSubstantial claim- The authors state this as an assumption: The effect sizes from the PI's preliminary work for self-monitoring levels parallel differences in weight loss across the treatment groups.
- Premisecitation
Timeliness of recording one's intake is related to weight loss.
“We also showed that timeliness of recording one’s intake is related to weight loss [24,49].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [24] Burke, 2008, Using instrumented paper diaries to document self-monitoring patterns in weight loss, Contemporary Clinical Trials source
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- cites [49] Burke, 2006, Ancillary study to the PREFER trial: a descriptive study of participants' patterns of self-monitoring: rationale, design and preliminary experiences, Contemp Clin Trials source
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- Premisecitation
Behavioral therapy is the primary treatment for obesity.
“The primary form of treatment for obesity today is behavioral therapy.”
- Also stated in: § 1. Introduction · plain
“At present the primary form of treatment for obesity is behavioral therapy, an approach that combines instruction about nutrition and exercise with behavioral strategies that facilitate behavior change [8,9].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [8] Wadden, 2007, Lifestyle modification for the management of obesity, Gastroenterology source
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- cites [9] Wing, 1998, Behavioral approaches to the treatment of obesity
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- Also stated in: § 1. Introduction · plain
- Premisecitation
Successful self-regulation depends in part on fidelity, consistency, and temporal proximity of self-monitoring.
“Therefore, successful self-regulation depends in part on the fidelity, consistency and temporal proximity of self-monitoring [29].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [29] Bandura, 1998, Health promotion from the perspective of social cognitive theory, Psychol Health source
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- Premisecitation
The design used in the trial is the current state of the science for standard behavioral treatment for weight loss.
“The design used in this trial is the current state of the science for standard behavioral treatment for weight loss”
Quote in the paperNot a substantial claim0 of 5 sources checked- cites [15] Tate, 2006, A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program, Arch Intern Med source
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- cites [51] Jakicic, 1999, Effects of intermittent exercise and use of home exercise equipment on adherence, weight loss, and fitness in overweight women: a randomized trial, JAMA source
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- cites [52] Tate, 2001, Using Internet technology to deliver a behavioral weight loss program, JAMA source
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- cites [53] Wadden, 2005, Randomized trial of lifestyle modification and pharmacotherapy for obesity, N Engl J Med source
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- cites [54] Wing, 1999, Benefits of recruiting participants with friends and increasing social support for weight loss and maintenance, J Consult Clin Psychol source
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- Interpretationnone given
Even a long-term pilot study of technology did not uncover the technical issues that were confronted in the early phase of the study.
“Even a long-term pilot study of technology did not uncover the technical issues that we had to confront in the early phase of the study.”
Quote in the paperNot a substantial claim - Premisecitation
The 2-year duration of the trial is longer than most studies.
“the 2-year duration is longer than most studies [15,51–54].”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [15] Tate, 2006, A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program, Arch Intern Med source
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- cites [51] Jakicic, 1999, Effects of intermittent exercise and use of home exercise equipment on adherence, weight loss, and fitness in overweight women: a randomized trial, JAMA source
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- cites [52] Tate, 2001, Using Internet technology to deliver a behavioral weight loss program, JAMA source
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- cites [53] Wadden, 2005, Randomized trial of lifestyle modification and pharmacotherapy for obesity, N Engl J Med source
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- cites [54] Wing, 1999, Benefits of recruiting participants with friends and increasing social support for weight loss and maintenance, J Consult Clin Psychol source
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- Premisecitation
Ongoing contact has been demonstrated to improve long-term adherence to behavior change.
“ongoing contact that has been demonstrated so often to improve long-term adherence to behavior change [55–58].”
Quote in the paperSubstantial claim0 of 4 sources checked- cites [55] Burke, 1997, Compliance with cardiovascular disease prevention strategies: a review of the research, Ann Behav Med source
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- cites [56] Osterberg, 2005, Adherence to medication, N Engl J Med source
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- cites [57] van Dulmen, 2007, Patient adherence to medical treatment: a review of reviews, BMC Health Serv Res source
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- cites [58] Weingarten, 2002, Interventions used in disease management programmes for patients with chronic illness-which ones work? Meta-analysis of published reports, BMJ source
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- Classified as probably not a substantial claim. 36
- May combine two claims. 23
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataSometimes the PDA saved incorrect nutritional information or displayed zero for daily totals.
“sometimes the PDA would save incorrect nutritional information or the daily totals would display zero”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataBreakage of PDAs occurred but was covered by the warranty contract.
“We have experienced breakage of the PDAs but these were covered by the warranty contract.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenBy BMI status, participants were obese.
“by BMI status they were obese”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingnone givenThe ethnic composition of the sample reflects the region's demographics, with 79% Whites.
“the ethnic composition reflects the region’s demographics with 79% Whites.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenThese technical problems did not occur with all participants' PDAs.
“it should be noted that these problems did not occur with all participants’ PDAs.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataOther technical problems included freezing of PDAs and fatal errors that prevented self-monitoring.
“Other problems included freezing of PDAs and getting fatal errors, which prevented participants from self-monitoring”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataMost participants were employed full time.
“Most participants were employed full time”
Quote in the paperNot a substantial claimMay combine two claims.
Findingnone givenThere was a higher representation of men in the early phases of screening, but they did not continue through the full screening process.
“We had a higher representation of men in the early phases of screening; however, they subsequently did not continue through the full screening process.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataMost participants had tried to lose weight previously.
“most had tried to lose weight previously”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenMost participants were fairly well educated.
“were fairly well educated”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenMany participants were overweight by early adulthood.
“Many participants were overweight by early adulthood”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataThe trial screened 704 individuals and randomized 210.
“We screened 704 individuals and randomized 210.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataThese freezing and fatal error problems did not affect all participants.
“again this did not affect all participants.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataNo PDAs were lost during the trial up to that point, including the first cohort that completed the study.
“we have not experienced the loss of any PDAs including the first cohort that has already completed the study.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataTechnical problems began at the start of the study, mainly caused by the hotsync upload process and the large number of transfers.
“technical problems started to appear at the very beginning of the study, which were mainly caused by the hotsync upload process and the large number of transfers.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataThe randomized sample was predominantly female and White.
“the randomized sample was predominately female and White”
- Also stated in: § 5. Discussion · plain
“our sample is predominantly female and White”
Quote in the paperNot a substantial claim- Also stated in: § 5. Discussion · plain
Probably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataTechnical problems occurred when using the added foods feature.
“These problems occurred while using the added foods feature”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe three cohorts differed statistically, but not clinically, on age, education, HDL cholesterol, blood glucose, and systolic blood pressure.
“There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataMore than half of participants had a family history of diabetes.
“more than half had a family history of diabetes”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingnone givenStudy participants quickly learned to use the software and PDA, and some used it extensively and incorporated it into daily life.
“Study participants quickly learned the use of the software and PDA and some used it extensively and incorporated it into their daily life.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThese non-randomized individuals differed significantly from randomized participants on race, marital status, employment, income, and education.
“These individuals were significantly different from those who were randomized on race (more Whites were randomized), marital status, employment, income and education (those currently or formerly married, working full time, or who had a higher income or education were more likely to be randomized).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe age difference between non-randomized and randomized groups was four years (49 vs. 45), with older individuals more likely to be randomized.
“The difference in age for the two groups was four years (49 vs. 45) with the older person more likely to be randomized.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenTrained, certified staff collected data with standardized procedures and questionnaires; equipment was calibrated routinely; questionnaires were reviewed for completeness and accuracy before the visit ended.
“Data were collected at the CTRC by trained and certified staff using standardized procedures and questionnaires. Equipment was standardized and routinely calibrated. Questionnaires were checked for accuracy and completeness prior to the participant leaving the center.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationcitationThe Glanz et al. study was short in duration and not focused on weight loss.
“While the latter study had positive results, it was short in duration and not focused on weight loss.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [48] Glanz, 2006, Improving dietary self-monitoring and adherence with hand-held computers: a pilot study, Am J Health Promot source
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenOnly trained project staff were allowed to scan or clean data, and they had to log in with a name and password.
“Only trained project staff were permitted to scan or clean the data and first had to provide a logon name and password.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningParticipants were divided by sex and White/non-White ethnicity so the three arms would be balanced.
“Individuals were stratified by gender and ethnicity (White vs. non-White) to ensure balance across the three treatment groups.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationLong-term weight loss maintenance lags far behind initial weight loss in behavioral treatment.
“According to Jeffery, the greatest achievement in behavioral treatment is increased initial weight loss; however, long-term weight loss lags far behind [10].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [10] Jeffery, 2000, Long-term maintenance of weight loss: current status, Health Psychol source
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Classified as probably not a substantial claim.
Study design and conductnone givenParticipants who withdrew or missed the final assessment would be included by imputing baseline weight, assuming no weight change.
“Individuals who withdraw or do not complete the final assessment will be included in the analysis by using the baseline weight as imputed values; in other words, no weight change will be assumed.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenThe study was approved by University of Pittsburgh IRB and all participants provided informed consent.
“This study was approved by the University of Pittsburgh Institutional Review Board. All participants provided informed consent.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone givenThe intention-to-treat approach tends to bias analyses toward the null hypothesis of no difference among groups.
“The ITT approach will tend to bias the analyses in the direction of the null hypothesis of no difference among groups.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationChanging habits requires developed self-regulatory skills.
“Kanfer has described self-regulation as a process having three distinct stages: self-monitoring, self-evaluation, and self-reinforcement, and suggests that changing habits requires developed self-regulatory skills [26–28].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [26] Kanfer, 1970, Self-monitoring: methodological limitations and clinical applications, J Consult Clin Psychol source
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- cites [27] Kanfer, 1971, The maintenance of behavior by self-generated stimuli and reinforcement
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- cites [28] Kanfer, 1980, Self-management methods
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Study design and conductnone givenThe study verified outcome data for accuracy after they were scanned into the centralized database.
“Data were verified for accuracy after they were scanned into the database.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe investigators anticipated enrolling 198 individuals to retain 156 participants at 24 months.
“We anticipated that we would need to enroll 198 individuals to retain 156 participants at 24 months.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
PremisecitationSelf-regulation has three stages: self-monitoring, self-evaluation, and self-reinforcement.
“Kanfer has described self-regulation as a process having three distinct stages: self-monitoring, self-evaluation, and self-reinforcement, and suggests that changing habits requires developed self-regulatory skills [26–28].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [26] Kanfer, 1970, Self-monitoring: methodological limitations and clinical applications, J Consult Clin Psychol source
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- cites [27] Kanfer, 1971, The maintenance of behavior by self-generated stimuli and reinforcement
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- cites [28] Kanfer, 1980, Self-management methods
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationHelsel et al. found no difference in weight loss between a traditional paper diary and a paper diary with transition to an abbreviated diary with checklists, but retention was less than 60%.
“Helsel et al. conducted a 16-week correspondence behavioral weight loss program (N=42) and compared traditional paper diary vs. traditional paper diary with transition to abbreviated diary with checklists and found no difference between the two groups in weight loss; however, retention was less than 60% [46].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] Helsel, 2007, Comparison of techniques for self-monitoring eating and exercise behaviors on weight loss in a correspondence-based intervention, J Am Diet Assoc source
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May combine two claims.
InterpretationreasoningThe SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare PDA use to conventional paper diaries.
“To the best of our knowledge, it is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper diaries.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe software programs for the PDA and custom upload applications were tested in a small pilot study before the SMART trial began.
“We tested the software programs for the PDA (DM Pro and Calcufit) as well as the custom upload applications in a small pilot study prior to the start of the SMART trial.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationcitationFindings from prior studies are equivocal regarding whether PDA use reduces subject burden for self-monitoring and improves long-term adherence and weight loss compared with paper diaries.
“Taken together, findings from these studies are equivocal regarding the use of a PDA to reduce subject burden for self-monitoring and improved long-term adherence and better weight loss compared with using a paper diary.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [46] Helsel, 2007, Comparison of techniques for self-monitoring eating and exercise behaviors on weight loss in a correspondence-based intervention, J Am Diet Assoc source
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- cites [47] Yon, 2007, Personal digital assistants are comparable to traditional diaries for dietary self-monitoring during a weight loss program, J Behav Med source
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- cites [48] Glanz, 2006, Improving dietary self-monitoring and adherence with hand-held computers: a pilot study, Am J Health Promot source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationSelf-monitoring is a cornerstone of behavioral treatment.
“Self-monitoring has been described as the “cornerstone” of behavioral treatment [20,21].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [20] Wadden, 1993, The treatment of obesity
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- cites [21] Baker, 1993, Self-monitoring may be necessary for successful weight control, Behav Ther source
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May combine two claims.
Interpretationnone givenAccording to the authors, SMART is the first large trial to compare self-monitoring methods in behavioral weight loss and to compare PDAs with paper records.
“To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records.”
Quote in the paperNot a substantial claim- Rests on an assumption: Before this trial, no large randomized study had compared paper records with PDA self-monitoring, with or without tailored daily feedback.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataBudget limits meant that blood lipids and glucose were measured only at baseline, 12 months, and 24 months.
“Due to budgetary constraints lipid and glucose assays were conducted only at the baseline, 12-month and 24-month assessments.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationGlanz et al. found that participants in a one-month pilot using hand-held computers significantly increased self-monitoring and met dietary goals more often compared to previous paper diary use.
“Glanz et al. conducted a one-month pilot study using hand-held computers in the Diet Modification arm of the Women’s Health Initiative and found that participants (N=33) significantly increased self-monitoring and met their dietary goals more often compared to previous use of PR for self-monitoring [48].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [48] Glanz, 2006, Improving dietary self-monitoring and adherence with hand-held computers: a pilot study, Am J Health Promot source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductreasoningThe analysis plan specified intention-to-treat, including all randomized participants according to their original assignment.
“Analyses will follow the intention-to-treat model (ITT), that is, all randomized participants will be included in the analyses according to their original assignment.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationBetter weight-loss treatment and maintenance can improve several obesity-related CHD risk factors and help lower the prevalence of the second most preventable cause of death.
“Improving weight loss treatment and maintenance can improve several of the obesity-related risk factors for CHD (e.g., insulin resistance, type 2 diabetes) and help reduce the prevalence of the second most preventable cause of death today [5–7].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [5] Klein, 2004, Clinical implications of obesity with specific focus on cardiovascular disease. A statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism, Circulation source
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- cites [6] Poirier, 2006, Circulation source
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- cites [7] Sacks, 2009, Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates, N Engl J Med source
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May combine two claims.
PremisecitationSelf-monitoring can be tedious, time-consuming, and burdensome.
“We based this intervention on data obtained from in-depth interviews focused on the experience of self-monitoring, which revealed that the process can be tedious, time-consuming and at times burdensome [30].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [30] Burke, 2009, Experiences of self-monitoring: narratives of success and struggle during treatment for obesity, Qual Health Res source
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Probably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningHaving necessary expertise in the research team and cooperation from the software developer helped overcome technical obstacles in a timely manner.
“having the necessary expertise in the research team members and the cooperation of the software developer helped to overcome those obstacles in a timely manner.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Before this trial, no large randomized study had compared paper records with PDA self-monitoring, with or without tailored daily feedback.
“To date, no large clinical trials have focused on comparing the standard paper record to the use of a personal digital assistant (PDA) with and without tailored, daily feedback in response to the reported behavior.”
The authors state this as an assumption.
The effect sizes from the PI's preliminary work for self-monitoring levels parallel differences in weight loss across the treatment groups.
“these effect sizes are expected to parallel the differences in weight loss across the treatment groups (PR, PDA, PDA+FB) with the level of significance adjusted to .01 to accommodate multiple testing”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In a two-year randomized clinical trial, at six months the PDA groups combined were more adherent to self-monitoring than the paper diary group, and dietary self-monitoring in this group had a significant indirect effect on percent weight loss.
“Findings at six months revealed that, compared to the paper diary group, the PDA groups combined were more adherent to self-monitoring and that dietary self-monitoring in this group had a significant indirect effect on percent weight loss (29, 36).”
From Self-monitoring in weight loss: a systematic review of the literature (2011) · cites this paper as [29]
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredParticipants did not encounter major difficulties learning to use PDAs and reported that PDA use was more socially acceptable for self-monitoring than recording in a paper diary.
“Participants did not encounter major difficulties in learning how to use the PDAs (Palm Tungsten/e2™, Palm, Inc., Sunnyvale, CA) and reported that using a PDA was more socially acceptable for self-monitoring than recording in a paper diary (29).”
From Self-monitoring in weight loss: a systematic review of the literature (2011) · cites this paper as [29]
Section 2.7 says most participants mastered basic PDA functions in the first two sessions, though some needed individual help. Section 4.1 reports that participants who liked the PDA found it socially acceptable for discreet public use, but it does not report that they found it more socially acceptable than a paper diary. (LLM, conf=0.87)
Experimental — accuracy not yet measuredExcept for early studies and a recent trial, none of the reviewed studies reported criteria by which they evaluated self-monitoring or how they defined completeness of diaries or log-in recordings.
“With the exception of the early studies (12, 22–24) that used therapists to grade diaries on several activities (e.g., foods eaten, time of eating, quantity of food) and a recent trial that defined self-monitoring adherence (29), none of the studies reported criteria by which they evaluated self-monitoring or how they defined completeness of diaries or log-in recordings.”
From Self-monitoring in weight loss: a systematic review of the literature (2011) · cites this paper as [29]
The SMART trial’s Methods (§2.5, page unavailable) describe assessing self-monitoring adherence through food and exercise records, diary-completion review, and time-stamped PDA entries. That supports identifying it as a trial that evaluated adherence, but our copy does not give explicit criteria defining an adherent or complete diary. The broader statement about the other reviewed studies is the citing authors’ conclusion, not a finding attributed to this trial. (LLM, conf=0.82)
Experimental — accuracy not yet measuredUse of technology and electronic devices that date- and time-stamp self-monitoring behavior provided objective validation of self-reported behaviors.
“The use of technology and electronic devices that date-and time-stamp the self-monitoring behavior (the diary entry or the actual weighing) provided an objective validation of these self-reported behaviors (29, 35).”
From Self-monitoring in weight loss: a systematic review of the literature (2011) · cites this paper as [29]
The main difference between Tate's study and our trial is that their computer feedback was weekly while our PDA-delivered feedback occurred daily.
“The main difference between that study and our trial is that the computer feedback message in their study was delivered on a weekly basis and our PDA-delivered feedback message occurred daily (16).”
From The Effect of Electronic Self‐Monitoring on Weight Loss and Dietary Intake: A Randomized Behavioral Weight Loss Trial (2011) · cites this paper as [16]
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Self-citationLow-Fat Milk and High-Fiber Bread Availability in Food Stores in Urban and Rural Communities
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Self-citation
Flagged first, then by citations
Research works printed but not linked: 2
- Burke, 2004, The barriers to healthy eating scale: psychometric report, Ann Behav Med, 27, S101
- Wadden, 2005, Randomized trial of lifestyle modification and pharmacotherapy for obesity, N Engl J Med, 353, 2111, 10.1056/NEJMoa050156 · DOI · Paper page
Cited by
Sorted by citations
Self-monitoring in weight loss: a systematic review of the literature
Burke, L. E., Wang, J., & Sevick, M. A. (2011) · Journal of the American Dietetic Association · doi:10.1016/j.jada.2010.10.008 · Cited by 1,203 · see citing works
“, Sunnyvale, CA) and reported that using a PDA was more socially acceptable for selfmonitoring than recording in a paper diary (29).”
InfluentialSelf-citationWeight-loss intervention adherence and factors promoting adherence: a meta-analysis
Rogers, M., Lemstra, M., Bird, Y., Nwankwo, C., & Moraros, J. (2016) · Patient Preference and Adherence · doi:10.2147/ppa.s103649 · Cited by 345 · see citing works
Burke, L. E., Conroy, M. B., Sereika, S. M., Elci, O. U., Styn, M. A., Acharya, S. D., Sevick, M. A., Ewing, L. J., & Glanz, K. (2011) · Obesity · doi:10.1038/oby.2010.208 · Cited by 329 · see citing works
Self-citationUsing mHealth Technology to Enhance Self-Monitoring for Weight Loss
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“The study design and methods for this 24-month RCT have been detailed elsewhere 17, 18 and thus are briefly reviewed here.”
MethodSelf-citationBurke, L. E., Shiffman, S., Music, E., Styn, M. A., Kriska, A., Smailagic, A., Siewiorek, D., Ewing, L. J., Chasens, E., French, B., et al. (2017) · Journal of Medical Internet Research · doi:10.2196/jmir.7138 · Cited by 267 · see citing works
Self-citationIntegrating Technology Into Standard Weight Loss Treatment: A Randomized Controlled Trial
Spring, B., Duncan, J. M., Janke, E. A., Kozak, A. T., McFadden, H. G., DeMott, A., Pictor, A., Epstein, L. H., Siddique, J., Pellegrini, C. A., et al. (2013) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2013.1221 · Cited by 234 · see citing works
Forman, E. M., Goldstein, S. P., Crochiere, R. J., Butryn, M. L., Juarascio, A. S., Zhang, F., & Foster, G. D. (2019) · Translational Behavioral Medicine · doi:10.1093/tbm/ibz137 · Cited by 94 · see citing works
Forman, E. M., Goldstein, S. P., Zhang, F., Evans, B. C., Manasse, S. M., Butryn, M. L., Juarascio, A. S., Abichandani, P., Martin, G. J., & Foster, G. D. (2019) · Translational Behavioral Medicine · doi:10.1093/tbm/iby016 · Cited by 77 · see citing works
Associations Between Self-Monitoring and Weight Change in Behavioral Weight Loss Interventions
Goldstein, S. P., Goldstein, C. M., Bond, D. S., Raynor, H. A., Wing, R. R., & Thomas, J. G. (2019) · Health Psychology · doi:10.1037/hea0000800 · Cited by 63 · see citing works
Sevick, M. A., Stone, R. A., Zickmund, S., Wang, Y., Korytkowski, M., & Burke, L. E. (2010) · Journal of Behavioral Medicine · doi:10.1007/s10865-010-9257-9 · Cited by 20 · see citing works
Self-citation
- Authors
- Burke, L. E., Styn, M. A., Glanz, K., Ewing, L. J., Elci, O. U., Conroy, M. B., Sereika, S. M., Acharya, S. D., Music, E., Keating, A. L., & Sevick, M. A.
- Affiliations
- University of Pittsburgh (US)
- Emory University (US)
- Corresponding author
- Burke, Lora E.
- ORCID
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2009-11
- Volume
- 30
- Issue
- 6
- Pages
- 540-551
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC2860431
- OpenAlex
- W2112778373
- Cited by
- 121
- References
- 65
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 4 · 2022: 4 · 2021: 6 · 2020: 6 · 2019: 9 · 2018: 10 · 2017: 15 · 2016: 6 · 2015: 10 · 2014: 10 · 2013: 9 · 2012: 13
- FWCI
- 17.92
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- D-Scholarship@Pitt (University of Pittsburgh) (acceptedVersion)
- Funders
- National Institutes of Health (1-DK71817, NR010742, 30-NR03924)
- National Center for Research Resources
- University of Pittsburgh
- Georgia Clinical and Translational Science Alliance (UL1 RR024153)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- self-monitoring, behavioral weight management, obesity, personal digital assistants, dietary self-monitoring, intervention adherence, weight loss, SMART trial
- MeSH terms
- Adult, Body Weights and Measures, Clinical Protocols, Diet, Female, Humans, Male, Middle Aged, Obesity, Patient Compliance, Patient Dropouts, Research Design, Socioeconomic Factors, Weight Loss, Exercise, Monitoring, Ambulatory, Computers, Handheld, Young Adult
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