Clinical Trial Of Weight Loss Research Articles

Postmenopausal women's experiences of weight maintenance following a very low energy diet.

Very low energy diets (VLEDs) effectively induce substantial weight loss in people with obesity, yet they are rarely used as a first line treatment. There is a belief that such diets do not teach the lifestyle behavior changes needed for long-term weight maintenance. However, little is known about the lived experiences of people who have lost weight on a VLED in the long term. This study aimed to explore the behaviors and experiences of postmenopausal women who had followed a 4-month VLED (using total meal replacement products [MRPs]), followed by a food-based, moderately energy-restricted diet for an additional 8months, as part of the TEMPO Diet Trial. Qualitative in-depth semi-structured interviews were conducted with 15 participants at 12 or 24months (i.e., at 8 or 20months post diet completion). Transcribed interviews were analyzed thematically using an inductive approach. Undertaking a VLED was reported by participants to confer advantages in weight maintenance that previous weight loss attempts had not been able to do for them. Firstly, the rapid and significant weight loss, in conjunction with ease of use, was motivational and helped instill confidence in the participants. Secondly, the cessation of a normal diet during the VLED was reported by participants to break weight gain-inducing habits, allowing them to abandon unhelpful habits and to introduce in their place more appropriate attitudes toward weight maintenance. Lastly, the new identity, helpful habits and increased self-efficacy around weight loss supported participants during weight maintenance. Additionally, participants reported that ongoing occasional use of MRPs provided a useful and easy new strategy for countering weight regain and supporting their weight maintenance regimen. Among the participants in this qualitative study, most of whom had maintained a loss of over 10% of their baseline body weight at the time of interview, using a VLED in the context of a clinical weight loss trial conferred confidence, motivation and skills for weight maintenance. These findings indicate that VLEDs with clinical support could be successfully leveraged to set up behaviors that will support weight maintenance in the long term.

Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial

BackgroundThe standard of care for treating overweight and obesity is daily caloric restriction (DCR). While this approach produces modest weight loss, adherence to DCR declines over time and weight regain is common. Intermittent fasting (IMF) is an alternative dietary strategy for reducing energy intake (EI) that involves >60% energy restriction on 2–3 days per week, or on alternate days, with habitual intake on fed days. While numerous studies have evaluated IMF as a weight loss strategy, there are several limitations including lack of a standard-of-care DCR control, failure to provide guideline-based behavioral support, and failure to rigorously evaluate dietary and PA adherence using objective measures. To date, only three longer-term (52-week) trials have evaluated IMF as a weight loss strategy. None of these longer-duration studies reported significant differences between IMF and DCR in changes in weight. However, each of these studies has limitations that prohibit drawing generalizable conclusions about the relative long-term efficacy of IMF vs. DCR for obesity treatment.MethodsThe Daily Caloric Restriction vs. Intermittent Fasting Trial (DRIFT) is a two-arm, 52-week block randomized (1:1) clinical weight loss trial. The two intervention arms (DCR and IMF) are designed to prescribe an equivalent average weekly energy deficit from baseline weight maintenance energy requirements. Both DCR and IMF will be provided guideline-based behavioral support and a PA prescription. The primary outcome is change in body weight at 52 weeks. Secondary outcomes include changes in body composition (dual-energy x-ray absorptiometry (DXA)), metabolic parameters, total daily energy expenditure (TDEE, doubly labeled water (DLW)), EI (DLW intake-balance method, 7-day diet diaries), and patterns of physical activity (PA, activPAL device).DiscussionAlthough DCR leads to modest weight loss success in the short-term, there is wide inter-individual variability in weight loss and poor long-term weight loss maintenance. Evidence-based dietary approaches to energy restriction that are effective long-term are needed to provide a range of evidence-based options to individuals seeking weight loss. The DRIFT study will evaluate the long-term effectiveness of IMF vs. DCR on changes in objectively measured weight, EI, and PA, when these approaches are delivered using guideline-based behavioral support and PA prescriptions.

Use of an mHealth Ketogenic Diet App Intervention and User Behaviors Associated With Weight Loss in Adults With Overweight or Obesity: Secondary Analysis of a Randomized Clinical Trial.

BackgroundLow-carbohydrate ketogenic diets are a viable method to lose weight that have regained popularity in recent years. Technology in the form of mobile health (mHealth) apps allows for scalable and remote delivery of such dietary interventions and are increasingly being used by the general population without direct medical supervision. However, it is currently unknown which factors related to app use and user behavior are associated with successful weight loss.ObjectiveFirst, to describe and characterize user behavior, we aim to examine characteristics and user behaviors over time of participants who were enrolled in a remotely delivered clinical weight loss trial that tested an mHealth ketogenic diet app paired with a breath acetone biofeedback device. Second, to identify variables of importance to weight loss at 12 weeks that may offer insight for future development of dietary mHealth interventions, we aim to explore which app- and adherence-related user behaviors characterized successful weight loss.MethodsWe analyzed app use and self-reported questionnaire data from 75 adults with overweight or obesity who participated in the intervention arm of a previous weight loss study. We examined data patterns over time through linear mixed models and performed correlation, linear regression, and causal mediation analyses to characterize diet-, weight-, and app-related user behavior associated with weight loss.ResultsIn the context of a low-carbohydrate ketogenic diet intervention delivered remotely through an mHealth app paired with a breath acetone biofeedback device, self-reported dietary adherence seemed to be the most important factor to predict weight loss (β=–.31; t54=–2.366; P=.02). Furthermore, self-reported adherence mediated the relationship between greater app engagement (from c=–0.008, 95% CI –0.014 to –0.0019 to c’=–0.0035, 95% CI –0.0094 to 0.0024) or higher breath acetone levels (from c=–1.34, 95% CI –2.28 to –0.40 to c’=–0.40, 95% CI –1.42 to 0.62) and greater weight loss, explaining a total of 27.8% and 28.8% of the variance in weight loss, respectively. User behavior (compliance with weight measurements and app engagement) and adherence-related aspects (breath acetone values and self-reported dietary adherence) over time differed between individuals who achieved a clinically significant weight loss of >5% and those who did not.ConclusionsOur in-depth examination of app- and adherence-related user behaviors offers insight into factors associated with successful weight loss in the context of mHealth interventions. In particular, our finding that self-reported dietary adherence was the most important metric predicting weight loss may aid in the development of future mHealth dietary interventions.Trial RegistrationClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707International Registered Report Identifier (IRRID)RR2-10.2196/19053

Weight and body composition changes affect resting energy expenditure predictive equations during a 12-month weight-loss intervention.

Mathematical equations that predict resting energy expenditure (REE) are widely used to derive calorie prescriptions during weight-loss interventions. Although such equations are known to introduce group- and individual-level error into REE prediction, their validity has largely been assessed in weight-stable populations. Therefore, this study sought to characterize how weight change affects the validity of commonly used REE predictive models throughout a 12-month weight-loss intervention. Changes in predictive error of four models (Mifflin-St-Jeor, Harris-Benedict, Owen, and World Health Organization/Food and Agriculture) were assessed at 1-, 6-, and 12-month time points in adults (n = 66, 76% female, aged 18-55 years, BMI = 27-45 kg/m2 ) enrolled in a randomized clinical weight-loss trial. All equations experienced significant negative shifts in bias (measured - predicted REE) toward overprediction from baseline to 1 month (p < 0.05). Three equations showed reversal of bias in the positive direction (toward underprediction) from baseline to 12 months (p < 0.05). Early changes in bias were correlated with decreased fat-free mass (p ≤ 0.01). Changes in body composition and mass during a 12-month weight-loss intervention significantly affected REE predictive error in adults with overweight and obesity. Weight history should be considered when using mathematical models to predict REE during periods of weight fluctuation.

Heterogeneity in the uptake, attendance, and outcomes in a clinical trial of a total diet replacement weight loss programme

BackgroundTrials have shown total diet replacement (TDR) programmes are safe and effective for weight loss in primary care. However, it is not clear whether participant characteristics affect uptake, attendance, or effectiveness of the programme.MethodsWe used data from 272 trial participants who were invited to participate in a clinical weight loss trial via a letter from their GP. We used a Cochran-Mantel-Haenszel analysis to assess whether accepting an invitation to participate in the trial differed by gender, age, BMI, social deprivation, and the presence of a diagnosis of type 2 diabetes or hypertension. We used mixed generalised linear modelling to examine whether participants’ age, gender, or social deprivation based on area of residence were associated with weight change at 12 months.ResultsMen were less likely to enrol than women (RR 0.59 [95% CI 0.47, 0.74]), and people from the middle and highest BMI tertile were more likely to enrol than those from the lowest tertile (RR 2.88 [95% CI 1.97, 4.22] and RR 4.38 [95% CI 3.05, 6.07], respectively). Patients from practices located in most deprived and intermediate deprived tertiles were more likely to enrol compared with those in the least deprived tertile (RR 1.84 [95% CI 1.81, 2.59] and RR 1.68 [95% CI 1.18, 2.85], respectively). There was no evidence that age or a pre-existing diagnosis of type 2 diabetes (RR 1.10 [95% CI 0.81, 1.50]) or hypertension (RR 0.81 [95% CI 0.62, 1.04]) affected enrolment. In the TDR group, 13% of participants were low engagers, 8% engaged with the weight loss phase only, and 79% engaged in both weight loss and weight maintenance phases of the programme. Those who engaged in the entire programme lost most weight. Subgroup analyses suggested that older participants and those with a higher baseline BMI lost more weight at 1 year than their comparators.ConclusionDespite some heterogeneity in the uptake and outcomes of the programme, if the results of this trial are replicated in routine practice, there is no evidence that TDR weight loss programmes would increase inequity.Trial registrationThe DROPLET trial was prospectively registered on ISRCTN registry (ISRCTN75092026).

Baseline Psychosocial and Demographic Factors Associated with Study Attrition and 12-Month Weight Gain in the DIETFITS Trial.

The purpose of this study was to examine correlates of failure-trial attrition and weight gain-in a randomized clinical weight-loss trial. The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) trial included 609 adults (18-50 years; BMI 28-40). Participants were randomized to a 12-month healthy low-fat or healthy low-carbohydrate diet for weight loss. At baseline, participants completed psychosocial, demographic, and anthropometric measures. Stepwise logistic regressions identified baseline factors associated with (1) study attrition and (2) among trial completers, weight gain at 12 months. Having higher baseline food addiction and self-efficacywas linked to treatment failure. Being younger, not having a college education, having higher outcome expectations and quality of life, and having lower social functioning and self-control increased the odds of trial attrition. Identifying as other than non-Hispanic white; not being married or cohabitating; having higher cognitive restraint and self-control; and having lower amotivation, family encouragement, and physical limitations increased the odds of gaining weight by treatment's end. Participants' baseline psychosocial and demographic factors may support or impede successful weight loss. Trialists should attend to these factors when designing treatments in order to promote participants' likelihood of completing the trial and achieving their weight-loss goals.

Predictive Mathematical Models of Weight Loss.

Validated thermodynamic energy balance models that predict weight change are ever more in use today. Delivery of model predictions using web-based applets and/or smart phones has transformed these models into viable clinical tools. Here, we provide the general framework for thermodynamic energy balance model derivation and highlight differences between thermodynamic energy balance models using four representatives. Energy balance models have been used to successfully improve dietary adherence, estimate the magnitude of food waste, and predict dropout from clinical weight loss trials. They are also being used to generate hypotheses in nutrition experiments. Applications of thermodynamic energy balance weight change prediction models range from clinical applications to modify behavior to deriving epidemiological conclusions. Novel future applications involve using these models to design experiments and provide support for treatment recommendations.

A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.

There is a need for new strategies to improve the success of obesity treatment within the primary care setting. To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6months. The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes. Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity. https://clinicaltrials.gov/ct2/show/NCT01922934.

Lessons Learned from the POUNDS Lost Study: Genetic, Metabolic, and Behavioral Factors Affecting Changes in Body Weight, Body Composition, and Cardiometabolic Risk.

This paper reviews the genetic and non-genetic factors that provided predictions of, or were associated with, weight loss and other metabolic changes in the POUNDS Lost clinical trial of weight loss. This trial randomized 811 individuals who were overweight or obese to one of four diets that contained either 15% or 25% protein and 20% or 40% fat in a 2× 2 factorial design. A standard behavioral weight loss program was available for all participants who were followed for 2years with an 80% completion rate. Nineteen genes and five genetic risk scores were used along with demographic, behavioral, endocrine, and metabolic measurements. Genetic variations in most of the genes were associated with weight loss, but this association often varied with the dietary assignment. A number of demographic and behavioral factors, including attendance at behavioral sessions and food cravings were predictive of weight changes. A high baseline level of free triiodothyronine or free thyroxine predicted the magnitude of weight loss. Several perfluoroakyl compounds predicted more rapid weight regain. Genetic evidence from POUNDS Lost provides guidance toward selection of a personalized weight loss diet and improvement in metabolic profile. There is still room for additional research into the predictors of weight loss.

High Prevalence of Undiagnosed Hyperglycemia in Low-Income Overweight and Obese Hispanic Women in Oregon.

Overweight Hispanic women are at high risk for type 2 diabetes. A clinical diagnosis of hyperglycemia is often necessary to access interventions. We examined the prevalence of undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC). Among 196 overweight or obese Hispanic women (mean age 44 ± 10years, mean weight 86.8 ± 16.5kg, mean body mass index [BMI] 36.5 ± 6.4kg/m2) enrolled in a randomized clinical weight-loss trial, we compared A1C and fasting blood glucose (FBG) obtained at baseline with women's existing diabetes and prediabetes diagnoses in the medical record. According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis. Among participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the prediabetes range (baseline A1C and FBG were in prediabetes range for 39 and 55 participants, respectively), and 13% (11/87) had at least one test in the diabetic range (baseline A1C and FBG values in diabetes range for 3 and 11 participants, respectively). We found substantial prevalence of undiagnosed hyperglycemia among a sample of overweight and obese Hispanic women. It is possible that limited awareness of diabetes risk may be a barrier to patient compliance with screening recommendations.

Long-term Association of Depression Symptoms and Antidepressant Medication Use With Incident Cardiovascular Events in the Look AHEAD (Action for Health in Diabetes) Clinical Trial of Weight Loss in Type 2 Diabetes.

To examine whether depression symptoms or antidepressant medication (ADM) use predicts the probability of cardiovascular events in overweight/obese individuals with type 2 diabetes. Preplanned analyses of depression and incident cardiovascular disease (CVD) were performed in the Look AHEAD (Action for Health in Diabetes) weight loss trial after a median follow-up of 9.6 years. Depression symptoms, assessed with the Beck Depression Inventory (BDI), were analyzed both as a continuous and dichotomized variable (BDI score <10 or ≥10). ADM use was coded from participants' prescription medications. Four composite CVD outcomes were defined in the study protocol. Sex-stratified Cox proportional hazards models were adjusted for a range of baseline covariates. Depression symptoms were only significantly associated with a composite secondary outcome comprising CVD death, nonfatal myocardial infarction, nonfatal stroke, hospitalized angina, congestive heart failure, peripheral vascular disease, coronary artery bypass graft, and carotid endarterectomy. Significant sex interactions were observed for BDI score and BDI score ≥10. BDI score was significantly associated with higher probability of this composite outcome in men but was not associated with the outcome in women. BDI score ≥10 was positively associated with this composite outcome in men but was negatively associated in women. Exploratory analysis identified a significant BDI ≥10 × ADM use interaction for this composite outcome that differed in men versus women. Men with both BDI score ≥10 and ADM use compared with those with neither had 60% higher probability of the outcome, whereas women with both compared with those with neither had 50% lower probability. Sex differences in the association of depression symptoms and ADM use with incident CVD warrant further investigation.

Predictors of Lifestyle Intervention Attrition or Weight Loss Success in Women with Polycystic Ovary Syndrome Who Are Overweight or Obese.

Background/objectives: Polycystic ovary syndrome (PCOS) is a common condition in reproductive-aged women. Weight management is a first-line treatment for PCOS according to international evidence-based guidelines. However, the factors associated with attrition or success in weight loss interventions are not known for women with PCOS. The objective of this study was to identify characteristics associated with attrition and weight loss success in women with PCOS and overweight or obesity undergoing weight loss interventions. Methods: Four randomised controlled clinical weight loss trials comprising energy restricted diets and/or exercise interventions of 2–8 months duration. The interventions were conducted over 2001–2007 in outpatient clinical research centres with n = 221 premenopausal women with PCOS and overweight/obesity recruited through community advertisement. The main outcome measures were attrition and ≥5% weight loss at 2 months and study completion. Results: Weight loss was 5.7 ± 2.9 kg at 2 months and 7.4 ± 5.3 kg after study completion (p < 0.001). Attrition was 47.1% and ≥5% weight loss occurred in 62.5% and 62.7% of women at 2 months and study completion respectively. Baseline depressive symptoms (OR 1.07 95% CI 0.88, 0.96, p = 0.032) and lower appointment attendance by 2 months (OR 0.92 95% CI 0.88, 0.96, p < 0.001) were independently associated with attrition. Lower appointment attendance over the whole study was independently associated with not achieving ≥5% weight loss at study completion (OR 0.95 95% CI 0.92, 0.99, p = 0.020). Conclusions: Despite high attrition, successful weight loss was achieved by 63% of women with PCOS in a clinical research setting. Higher baseline depressive symptoms were associated with greater attrition and higher appointment attendance was associated with lower attrition and greater weight loss success. These finding have implications for development of successful weight management programs in PCOS.

Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial

BackgroundRegulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity.MethodsThis study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics.ResultsAll randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F(1,112) = .15, p = .699), CRF length (F(2,112) = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was superior in the eCRF condition (0 versus 3 data entry errors).ConclusionsThis is the first study to prove in direct comparison that using eCRFs instead of pCRFs increases time efficiency of data collection in clinical trials, irrespective of item quantity or patient age, and improves data quality.Trial registrationClinical Trials NCT02649907.

Shorter Mandibular Length is Associated with a Greater Fall in AHI with Weight Loss.

Obesity is a major risk factor towards the development of obstructive sleep apnea, while significant weight loss (both conservatively managed and surgically assisted) has a variable effect upon its severity. Differences in the effect of weight loss on obstructive sleep apnea may be due to underlying craniofacial characteristics. To determine whether craniofacial characteristics can predict OSA treatment response to significant weight loss. We analyzed craniofacial measurements from lateral cephalograms performed at baseline on 57 patients enrolled in a previously reported 2-year randomized clinical weight loss trial (laparoscopic adjustable gastric band surgery versus conservatively [dietician and very low calorie diet] treated). Group mean weight loss was ∼ 13% (mean weight loss 131 to 114 kg), with corresponding reduction in mean apnea-hypopnea index (AHI) from 61 to 41 events/h. Computer assisted lateral cephalogram analysis was undertaken by three trained staff blinded to treatment. We analyzed lateral cephalogram and demographic data at baseline (cross-sectional) and change over two years (interventional) in 54 patients. Baseline cross-sectional analysis indicated no cephalometric measurement correlated significantly with baseline AHI when corrected for neck circumference. The percentage change in AHI over 2 years correlated with a shorter menton-gonion distance (i.e., mandibular body length). The % change in AHI correlated with the % weight change (R(2) = 0.25, p < 0.001) and mandibular body length (R(2) = 0.19, p = 0.002). The % change in AHI correlated with combined weight change and mandibular body length (combined R(2) = 0.31, p < 0.001). Weight loss as a therapeutic option for severe OSA with severe obesity may be predicted by shorter mandibular body length as measured by lateral cephalometry.

Effect of a 4-week weight maintenance diet on circulating hormone levels: implications for clinical weight loss trials.

The majority of weight loss studies fail to standardize conditions such as diet and exercise via a weight maintenance period prior to commencement of the trial. This study aimed to determine whether a weight stabilization period is necessary to establish stable baseline hormone concentrations. Fifty-one obese male participants with a body mass index of 30-40 kg m(-2) and aged 25-54 years underwent 4 weeks on an energy balance diet that was designed to achieve weight stability. Blood samples were collected in the fasting state at commencement and completion of the 4-week period, and circulating concentrations of 18 commonly measured hormones were determined. During the 4-week weight maintenance period, participants achieved weight stability within -1.5 ± 0.2 kg (-1.4 ± 0.2%) of their initial body weight. Significant reductions in serum insulin (by 18 ± 6.5%) and leptin (by 21 ± 6.0%) levels occurred, but no significant changes were observed for gut-derived appetite-regulating hormones (ghrelin and peptide YY), nor thyroid, adrenal, gonadal or somatotropic hormones. There were no significant correlations between the change in body weight and the change in circulating concentrations of insulin or leptin over the 4-week period, indicating that the observed changes were not due to weight loss, albeit significant negative correlations were observed between the changes in body weight and plasma ghrelin and peptide YY levels. This study demonstrates the need for baseline weight maintenance periods to stabilize serum levels of insulin and leptin in studies specifically investigating effects on these parameters in the obese. However, this does not apply to circulating levels of gut-derived appetite-regulating hormones (ghrelin and peptide YY), nor thyroid, adrenal, gonadal or somatotropic hormones.

Four-Year Analysis of Cardiovascular Disease Risk Factors, Depression Symptoms, and Antidepressant Medicine Use in the Look AHEAD (Action for Health in Diabetes) Clinical Trial of Weight Loss in Diabetes

OBJECTIVETo study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes.RESEARCH DESIGN AND METHODSParticipants (n = 5,145; age [mean ± SD] 58.7 ± 6.8 years; BMI 35.8 ± 5.8 kg/m2) in two study arms (intensive lifestyle [ILI], diabetes support and education [DSE]) completed the Beck Depression Inventory (BDI), reported ADM use, and were assessed for CVD risk factors at baseline and annually for 4 years. Risk factor–positive status was defined as current smoking, obesity, HbA1c >7.0% or insulin use, and blood pressure or cholesterol not at levels recommended by expert consensus panel or medicine to achieve recommended levels. Generalized estimating equations assessed within-study arm relationships of elevated BDI score (≥11) or ADM use with subsequent year CVD risk status, controlled for demographic variables, CVD history, diabetes duration, and prior CVD risk status.RESULTSPrior year elevated BDI was associated with subsequent CVD risk factor–positive status for the DSE arm (A1C [odds ratio 1.30 (95% CI 1.09–1.56)]; total cholesterol [0.80 (0.65–1.00)]; i.e., protective from high total cholesterol) and the ILI arm (HDL [1.40 (1.12–1.75)], triglyceride [1.28 (1.00–1.64)]). Prior year ADM use predicted subsequent elevated CVD risk status for the DSE arm (HDL [1.24 (1.03–1.50)], total cholesterol [1.28 (1.05–1.57)], current smoking [1.73 (1.04–2.88)]) and for the ILI arm (A1C [1.25 (1.08–1.46)], HDL [1.32 (1.11–1.58)], triglycerides [1.75 (1.43–2.14)], systolic blood pressure [1.39 (1.11–1.74)], and obesity [1.46 (1.22–2.18)]).CONCLUSIONSAggressive monitoring of CVD risk in diabetic patients with depressive symptoms or who are treated with ADM may be warranted.

Recruiting young adults into a weight loss trial: Report of protocol development and recruitment results

Obesity has spread to all segments of the U.S. population. Young adults, aged 18–35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18–35years with BMI ≥25kg/m2. Six group discussions were conducted using the nominal group technique. Health, social image, and “self” factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed.

Effectiveness of strategies for recruiting overweight and obese Generation Y women to a clinical weight management trial.

Limited research in young overweight and obese women indicates that they are difficult to recruit to weight management trials, with attrition higher and weight loss success lower than middle to older age participants. This study aimed to evaluate the effectiveness of different recruitment strategies for a clinical weight loss trial in overweight and obese Generation Y women. Overweight and obese (BMI >=27.5 kg/m-2) women aged 18-25 years (n=70) were required for a 12 month clinical weight management trial including diet, exercise and behaviour modification. Contact with researchers and eventual recruitment are reported for the various strategies employed to engage participants. Data reported as % or mean±SE. Recruitment was challenging with only 50 of the total 70 participants recruited within the scheduled time frame (24 months). Just over one quarter (27%) of volunteers assessed were recruited. Flyers posted around local tertiary education campuses were the most successful method, yielding 36% of included participants. This was followed by advertisements on the local area health service intranet (26%) and in local and metropolitan newspapers (16%). Recruitment of overweight and obese Generation Y women for a clinical weight loss trial was difficult. Multiple strategies targeted at this age and gender group were required. Less rigorous selection criteria and reduced face-to-face intervention time may improve recruitment and retention rates into clinical trials for this age group.

Baseline dietary patterns are a significant consideration in correcting dietary exposure for weight loss

Dietary pattern studies are traditionally the domain of epidemiological research. From a clinical perspective, there is a need to explore the effects of changing food and dietary patterns of individuals. The aim was to identify patterns of food choice in the context of a clinical weight loss trial. Cluster analysis based on reported serves of food groups revealed dietary patterns informative for the clinical setting. Cluster analysis was conducted using diet history data from two clinical trials at baseline, and outcomes at 3 months were reviewed based on these clusters (n=231). The cluster solution was analysed using defined food groups in serves and with respect to clinical parameters and requirements for selected nutrients. Two distinct dietary patterns were identified from the reported baseline dietary intakes. Subjects in Cluster 1 reported food patterns characterised by higher intakes of low-fat dairy and unsaturated oils and margarine and were generally more closely aligned to food choices encouraged in national dietary guidelines. Subjects in Cluster 2 reported a dietary pattern characterised by non-core foods and drinks, higher- and medium-fat dairy foods, fatty meats and alcohol. At 3 months, Cluster 2 subjects reported greater reductions in energy intake (-5317 kJ; P<0.001) and greater weight loss (-5.6 kg; P<0.05) compared with Cluster 1. Overweight subjects with reported dietary patterns similar to dietary guidelines at baseline may have more difficulty in reducing energy intake than those with poor dietary patterns. Correcting exposure to non-core foods and drinks was key to successful weight loss.

Decrease in Urinary Incontinence Management Costs in Women Enrolled in a Clinical Trial of Weight Loss to Treat Urinary Incontinence

Direct costs for management of urinary incontinence (UI) among middle-aged and older women exceed $20 billion per year in the United States. Greater than 50% of the costs of managing incontinence are due to routine use of resources used for incontinence management, such as absorbent pads, protection, and laundry. A number of studies have shown that increased frequency of UI is associated with higher incontinence management costs. It is not known whether successful treatment of incontinence would decrease the costs of management. The present study was a secondary analysis of a previously published randomized clinical trial that demonstrated the efficacy of an 18-month weight loss and maintenance program among obese and overweight women with UI. The aim of this study was to estimate the effect of decreased frequency of incontinence on UI management costs among women enrolled in that trial and to identify factors that may be predictive for changes in cost. A total of 338 obese and overweight women with 10 or more weekly episodes of UI at baseline were randomized to treatment with either the weight loss intervention program or a structured education program. Self-reported use of resources in a typical week for incontinence management (including pads, additional laundry, and dry cleaning) was assessed. Mean direct costs of UI management were calculated by multiplying units of resources used by the mean national resource costs per unit presented in 2006 US dollars. The effects of change in incontinence frequency on cost were examined by combining randomized groups. Generalized estimating equations were used to examine possible predictors of change in cost, adjusting for factors associated with change in cost that were identified in univariable analyses. The frequency of incontinent episodes was assessed at 6- and 18-month follow-up in both groups. Data were expressed as mean ± SD. At baseline, mean age of the subjects was 53 ± 10 years, weight was 97 ± 17 kg, and weekly UI frequency was 24 ± 18. Urinary incontinence frequency was decreased by 37% at 6 months and by 60% at 18 months (both P < 0.001). In multivariable models, adjusted mean cost at baseline was $7.76 ± $14 per week, and costs increased significantly with greater frequency of incontinence. Total mean management costs, adjusted for clinical site, were reduced by 54% at 6 months and 81% at 18 months (both P < 0.001). In the adjusted data, decreased costs were independently associated with weight loss; for every decrease of 7 total UI episodes per week, costs were decreased by 23%, and for every 5-kg decrease in weight, weekly costs decreased 21% (both P < 0.001). These findings show that among overweight and obese women enrolled in a weight loss program for UI, there is a substantial decrease in incontinence management costs at 18 months that is independently associated with decreasing incontinence frequency.