Edvin Music

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings

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.

Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers

Objectives: To describe participants’ adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases. Methods: A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m2). The sample was 86.9% female, 70.5% White, and 44.4 ± 8.6 years old. The outcome measures included weight and biomarkers. Results: There was a significant decline in adherence to each treatment component over time (P < 0.0001). In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05). Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05). Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05). Conclusions: We observed a decline in adherence to each treatment component as the intervention intensity was reduced. Adherence to multiple treatment components was associated with greater weight loss and improvements in biomarkers. Future research needs to focus on improving and maintaining adherence to all components of the treatment protocol to promote weight loss and maintenance.

A randomized clinical trial of a standard versus vegetarian diet for weight loss: the impact of treatment preference

Background:With obesity rampant, methods to achieve sustained weight loss remain elusive.Objective:To compare the long-term weight-loss efficacy of 2 cal and fat-restricted diets, standard (omnivorous) versus lacto–ovo–vegetarian, and to determine the effect of a chosen diet versus an assigned diet.Design, subjects:A randomized clinical trial was conducted with 176 adults who were sedentary and overweight (mean body mass index, 34.0 kg/m2). Participants were first randomly assigned to either receive their preferred diet or be assigned to a diet group and second, were given their diet of preference or randomly assigned to a standard weight-loss diet or a lacto–ovo–vegetarian diet. Participants underwent a university-based weight-control program consisting of daily dietary and exercise goals plus 12 months of behavioral counseling followed by a 6-month maintenance phase.Measurements:Percentage change in body weight, body mass index, waist circumference, low- and high-density lipoprotein, glucose, insulin and macronutrient intake.Results:The program was completed by 132 (75%) of the participants. At 18 months, mean percentage weight loss was greater (P=0.01) in the two groups that were assigned a diet (standard, 8.0% (s.d., 7.8%); vegetarian, 7.9% (s.d., 8.1%)) than in those provided the diet of their choice (standard, 3.9% (s.d., 6.1%); vegetarian, 5.3% (s.d., 6.2%)). No difference was observed in weight loss between the two types of diet. Over the 18-month program, all groups showed significant weight loss.Conclusions:Participants assigned to their dietary preference did not have enhanced treatment outcomes. However, all groups lost weight with losses ranging from 4 to 8% at 18 months.

Salivary gonadal and adrenal hormone differences in boys and girls with and without disruptive behavior disorders: Contextual variants.

Hormone differences by psychopathology group and gender may have implications for understanding disruptive behavior disorders (DBDs) and complexities of treatment outcomes. Current theoretical models emphasize contextual differences as moderators of hormone-behavior relations. This baseline report examined: (a) hormone differences in youth with and without DBD, and (b) contextual factors as moderators of behavior problems and hormones. 180 children and adolescents were enrolled (141 boys, mean 9.0+/-1.7 years). DBD participants met criteria for conduct disorder (CD) and/or oppositional defiant disorder (ODD) (n=111); 69 were recruited as healthy comparisons (HC). Saliva was collected for testosterone, cortisol, dehydroepiandrosterone and androstenedione. DBD youth had significantly higher androstenedione than the HC group. There was a group by gender interaction for basal cortisol mean with DBD boys and HC girls having lower cortisol. Moderating effects of contextual variables (e.g., family functioning, delinquent peers) were noted for cortisol and adrenal androgens. Findings argue for considering hormones as an influence on DBD beyond simple direct one-to-one associations.

A Randomized Clinical Trial Testing Treatment Preference and Two Dietary Options in Behavioral Weight Management: Preliminary Results of the Impact of Diet at 6 Months—PREFER Study

Objective: The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie‐ and fat‐restricted diets [standard behavior treatment (SBT) and lacto‐ovo‐vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention.

The SELF Trial: A self-efficacy based behavioral intervention trial for weight-loss maintenance

The SELF Trial examined the effect of adding individual self‐efficacy (SE) enhancement sessions to standard behavioral weight loss treatment (SBT).

Evaluation of the shortened Cholesterol-Lowering Diet Self-Efficacy Scale.

Specificity in the self-efficacy construct requires that instruments assess domain-specific behaviors. The objectives of the study were to (1) reexamine and shorten the original 57-item Cholesterol-Lowering Diet Self-Efficacy Scale (CLDSES), (2) estimate reliability and validity of the short form CLDSES (CLDSES-SF), (3) examine the dimensionality of the CLDSES-SF, (4) examine discriminant validity of the scale by its ability to differentiate between adherence and nonadherence to saturated fat intake guidelines, and (5) examine the CLDSES-SFs sensitivity and specificity. A sample of 238 patients being treated for hypercholesterolemia completed three instruments: the CLDSES, the Connor Diet Habit Survey (DHS) and a Three-Day Food Record. Internal consistency for the CLDSES-SF was .95. The inter-correlation coefficients among the seven sub-scales ranged from .28 to .62, and for the total to sub-scales .58 — .87, significant at p < .001. Evidence for criterion validity was shown in the correlations between the CLDSES-SF and the Connor DHS scores and between the CLDSES-SF and the Three-Day Food Record. Factor analysis showed a one-factor model that fits the data with a sufficient amount of total variance explained among the seven subscale items in each subscale, providing evidence of the uni-dimensionality of each subscale. Sensitivity (76%) and specificity (63%) for the CLDSES-SF were good with 88% positive predictive value for adherence. The shortened CLDSES retained its good psychometric properties and remains comprehensive in its assessment of self-efficacy for adherence to a cholesterol-lowering diet.

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring

Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1–4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (− 2.85% vs. − 3.14% vs. − 3.37%) (p = 0.95); 26% of the participants lost ≥ 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.

1415 Evaluation of the Cholesterol-Lowering Diet Scale-Short Form

the clinical significance of restenos besides the assessment need for further revascularization. The aim of this qualitative study was to ascertain the patients’ experience of restenos. Method: Nine patients were interviewed in-depth. The patients had undergone at least one PCI and some had also undergone coronary artery bypass grafting. They showed a reoccurrence of angina pectoris and had undergone a new coronary angiography, which showed a significant restenosis requiring a new intervention. Data collection and analysis were done simultaneously according to Grounded Theory methodology and continued until new interviews provided no additional information, i.e., saturation was met. Results: We identified bliving with uncertaintyQ as the core of these patients’ experiences of their situation. Four categories were related to this core category giving further understanding of the uncertain situation, i.e., fighting for access to care, moderating health threats, trying to understand and controlling relatives’ anxiety. The categories formed a conceptual model, describing the experienced life situation of patients with restenos following a previous PCI. Conclusion: Patients’ perceptions of illness and illnessrelated events, such as symptoms, diagnosis, treatment and prognosis, are affected by uncertainty. This might increase stress reactions and decrease active coping strategies, e.g., behaviour change and information seeking, and encourage intrapsychic coping such as vigilance and avoidance.