Web‐based Weight Loss in Primary Care: A Randomized Controlled Trial

Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting. We conducted a 12-week randomized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension. Patients had access to a comprehensive website that used a moderate-intensity weight loss approach designed specifically for web-based implementation. Patients also participated in four (two in-person and two telephonic) counseling sessions with a health coach. Intent-to-treat analysis showed greater weight loss at 3 months (−2.56 kg; 95% CI −3.60, −1.53) among intervention participants (−2.28 ± 3.21 kg), relative to usual care (0.28 ± 1.87 kg). Similar findings were observed among intervention completers (−3.05 kg; 95% CI −4.24, −1.85). High rates of participant retention (84%) and website utilization were observed, with the greatest weight loss found among those with a high frequency of website logins (quartile 4 vs. 1: −4.16 kg; 95% CI −1.47, −6.84). The intervention's approach promoted moderate weight loss at 12 weeks, though greater weight loss was observed among those with higher levels of website utilization. Efficacious web-based weight loss interventions can be successfully offered in the primary care setting.     

The SHED‐IT Randomized Controlled Trial: Evaluation of an Internet‐based Weight‐loss Program for Men

The aim of this study was to evaluate the efficacy of an Internet‐based weight‐loss program for men in an assessor blinded randomized controlled trial. In total, 65 overweight/obese male staff and students at the University of Newcastle (mean (s.d.) age = 35.9 (11.1) years; BMI = 30.6 (2.8)) were randomly assigned to either (i) Internet group (n = 34) or (ii) control group (information only) (n = 31). Both groups received one face‐to‐face information session and a program booklet. Internet group participants used the study website to self‐monitor diet and activity with feedback provided based on participants' online entries on seven occasions over 3 months. Participants were assessed at baseline, 3‐, and 6‐month follow‐up for weight, waist circumference, BMI, blood pressure, resting heart rate, objectively measured physical activity, and self‐reported total daily kilojoules. Intention‐to‐treat analysis revealed significant weight loss of 5.3 kg (95% confidence interval (CI): ?7.3, ?3.3) at 6 months for the Internet group and 3.5 kg (95% CI: ?5.5, ?1.4) for the control group. A significant time effect was found for all outcomes but no between‐group differences. Per‐protocol analysis revealed a significant group‐by‐time interaction (P < 0.001), with compliers losing more weight at 6 months (?9.1 kg; 95% CI ?11.8, ?6.5) than noncompliers (?2.7 kg; 95% CI ?5.3, ?0.01) and the control group (?4.2 kg; 95% CI ?6.2, ?2.2). Simple weight‐loss interventions can be effective in achieving statistically and clinically significant weight loss in men. The Internet is a feasible and effective medium for weight loss in men but strategies need to be explored to improve engagement in online programs.     

Reducing Anti‐Fat Prejudice in Preservice Health Students: A Randomized Trial

Anti‐fat sentiment is increasing, is prevalent in health professionals, and has health and social consequences. There is no evidence for effective obesity prejudice reduction techniques in health professionals. The present experiment sought to reduce implicit and explicit anti‐fat prejudice in preservice health students. Health promotion/public health bachelor degree program students (n = 159) were randomized to one of three tutorial conditions. One condition presented an obesity curriculum on the controllable reasons for obesity (i.e., diet/exercise). A prejudice reduction condition presented evidence on the uncontrollable reasons for obesity (i.e., genes/environment); whereas a neutral (control) curriculum focused on alcohol use in young people. Measures of implicit and explicit anti‐fat prejudice, beliefs about obese people, and dieting, were taken at baseline and postintervention. Repeated measures analyses showed decreases in two forms of implicit anti‐fat prejudice (decreases of 27 and 12%) in the genes/environment condition relative to other conditions. The diet/exercise condition showed a 27% increase in one measure of implicit anti‐fat prejudice. Reductions in explicit anti‐fat prejudice were also seen in the genes/environment condition (P = 0.006). No significant changes in beliefs about obese people or dieting control beliefs were found across conditions. The present results show that anti‐fat prejudice can be reduced or exacerbated depending on the causal information provided about obesity. The present results have implications for the training of health professionals, especially given their widespread negativity toward overweight and obesity.     

Effects of Sibutramine Plus Orlistat in Obese Women Following 1 Year of Treatment by Sibutramine Alone: A Placebo‐Controlled Trial

Objective: This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight while taking sibutramine alone. Research Methods and Procedures: Patients were 34 women with a mean age of 44.1 ± 10.4 years, weight of 89.4 ± 13.8 kg, and body mass index (BMI) of 33.9 ± 4.9 kg/m² who had lost an average of 11.6 ± 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double‐blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification visits during the 16‐week continuation trial. Results: Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight loss as compared with treatment by sibutramine alone (mean changes = +0.1 ± 4.1 kg vs. +0.5 ± 2.1 kg, respectively). Discussion: These results must be interpreted with caution because of the study's small sample size. The findings, however, suggest that the combination of sibutramine and orlistat is unlikely to have additive effects that will yield mean losses ≥15% of initial weight, as desired by many obese individuals.     

An Economic Evaluation of TENS in Addition to Usual Primary Care Management for the Treatment of Tennis Elbow: Results from the TATE Randomized Controlled Trial

Background

The TATE trial was a multicentre pragmatic randomized controlled trial of supplementing primary care management (PCM)–consisting of a GP consultation followed by information and advice on exercises–with transcutaneous electrical nerve stimulation (TENS), to reduce pain intensity in patients with tennis elbow. This paper reports the health economic evaluation.

Methods and Findings

Adults with new diagnosis of tennis elbow were recruited from 38 general practices in the UK, and randomly allocated to PCM (n = 120) or PCM plus TENS (n = 121). Outcomes included reduction in pain intensity and quality-adjusted-life-years (QALYs) based on the EQ5D and SF6D. Two economic perspectives were evaluated: (i) healthcare–inclusive of NHS and private health costs for the tennis elbow; (ii) societal–healthcare costs plus productivity losses through work absenteeism. Mean outcome and cost differences between the groups were evaluated using a multiple imputed dataset as the base case evaluation, with uncertainty represented in cost-effectiveness planes and through probabilistic cost-effectiveness acceptability curves). Incremental healthcare cost was £33 (95%CI -40, 106) and societal cost £65 (95%CI -307, 176) for PCM plus TENS. Mean differences in outcome were: 0.11 (95%CI -0.13, 0.35) for change in pain (0–10 pain scale); -0.015 (95%CI -0.058, 0.029) for QALY_EQ5D; 0.007 (95%CI -0.022, 0.035) for QALY_SF6D (higher score differences denote greater benefit for PCM plus TENS). The ICER (incremental cost effectiveness ratio) for the main evaluation of mean difference in societal cost (£) relative to mean difference in pain outcome was -582 (95%CI -8666, 8113). However, incremental ICERs show differences in cost–effectiveness of additional TENS, according to the outcome being evaluated.

Conclusion

Our findings do not provide evidence for or against the cost-effectiveness of TENS as an adjunct to primary care management of tennis elbow.     

Features and Trajectories of Eating Behavior in Weight‐Loss Maintenance: Results from the German Weight Control Registry

Objective

Eating behaviors such as dietary restraint and disinhibition caused by emotional and external cues play a relevant role in weight‐loss maintenance.

Methods

Four hundred forty individuals with successful weight‐loss maintenance included in the prospective German Weight Control Registry completed the Dutch Eating Behavior Questionnaire. Participants were categorized into the following two weight groups: stable weight trajectory (WS) (n = 280) and unstable weight trajectory (WUS) (n = 160) over the 2‐year assessment period.

Results

Those with successful weight‐loss maintenance had significantly higher scores on the restrained and emotional eating subscales compared with a general population (GP) sample. At baseline, the WS individuals had lower restrained, emotional, and external eating scores compared with the WUS individuals. Over the 2‐year follow‐up period, the trajectories of the restraint scores decreased in both groups but stayed elevated compared with the GP sample. Scores of the emotional and external eating subscales remained stable in the WS group but increased in the WUS group.

Conclusions

A certain degree of restraint seems to be necessary for successful weight‐loss maintenance; however, high emotional and external eating may counteract this effect, resulting in weight regain in the long run.     

A Two‐Year Bio‐Agronomic and Chemotaxonomic Evaluation of Wild Sicilian Myrtle (Myrtus communis L.) Berries and Leaves

A collection of nine Myrtus communis samples from different localities of Sicily was evaluated. Morphological traits and production characteristics have been chosen as parameters to arrange the samples into homogeneous groups and to identify the best biotypes for possible future agro‐industrial exploitation. The plant material has been subjected to taxonomic characterization from biometric and phytochemical perspectives. Myrtle berries and leaves have been analyzed for their content in metabolites, applying a cascade extraction protocol for M. communis leaves and a single hydroalcoholic extraction for berries, whereas hydrodistillation procedures have been applied to obtain the essential oils from berries and leaves. The analyses of non‐volatile components were carried out by LC‐UV‐DAD‐ESI‐MS. All the extracts were characterized by the presence of numerous polyphenols, namely highly hydroxylated flavonols such as quercetin and myricetin; and ellagic acid detected in all samples. In addition, myrtle berries contained nine different anthocyanins, namely delphinidin, petunidin, cyanidin and malvidin derivatives. The essential oils (EOs) were analyzed by a combination of GC‐FID and GC/MS. A total of 33 and 34 components were fully characterized with the predominance of α‐pinene, myrtenyl acetate, linalool, 1,8‐cineole and linalyl acetate. All phytochemical profiles were subjected to cluster analyses, which allowed subdividing the myrtle samples in different chemical groups.     

Guided Self-Help Cognitive Behavioural Therapy for Depression in Primary Care: A Randomised Controlled Trial

Background

Access to Cognitive behavioural therapy (CBT) for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT) on mood, compared to treatment as usual (TAU).Hypotheses:

1. GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAU
2. Guided self-help will be acceptable to patients and staff.

Methods and Findings

Participants: Adults attending seven general practices in Glasgow, UK with a BDI-II score of ≥14. 141 randomised to GSH-CBT and 140 to TAU. Interventions: RCT comparing ‘Overcoming Depression: A Five Areas Approach’ book plus 3–4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU. Primary outcome: The BDI (II) score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome), 117 at 12 months. Outcome: Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001). At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI—II category change).

Limitations

Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%). In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment.

Conclusions

GSH-CBT is substantially more effective than TAU.

Trial Registration

Controlled-Trials.com ISRCTN13475030     

A Primary Care Intervention for Weight Loss: Results of a Randomized Controlled Pilot Study

Most primary care providers (PCPs), constrained by time and resources, cannot provide intensive behavioral counseling for obesity. This study evaluated the effect of using medical assistants (MAs) as weight loss counselors. The study was a randomized controlled trial conducted in two primary care offices at an academic medical center. Patients (n = 50) had a BMI of 27–50 kg/m² and no contraindications to weight loss. They were randomized to quarterly PCP visits and weight loss materials (Control group) or to the same approach combined with eight visits with a MA over 6 months (Brief Counseling). Outcomes included change in weight and cardiovascular risk factors (glucose, lipids, blood pressure, and waist circumference). Patients in the Brief Counseling and Control groups lost 4.4 ± 0.6 kg (5.1 ± 0.7% of initial weight) and 0.9 ± 0.6 kg (1.0 ± 0.7%), respectively, at month 6 (P < 0.001). There were no significant differences between groups for changes in cardiovascular risk factors. Brief Counseling patients regained weight between month 6 and month 12, when MA visits were discontinued. Attrition was 10% after 6 months and 6% after 12 months. Brief Counseling by MAs induced significant weight loss during 6 months. Office‐based obesity treatment should be tested in larger trials and should include weight loss maintenance counseling.     

Metabolic and Weight Loss Effects of Long‐Term Dietary Intervention in Obese Patients: Four‐Year Results

Objective: To investigate the contribution of meal and snack replacements for long‐term weight maintenance and risk factor reduction in obese patients. Research Methods and Procedures: Prospective, randomized, two‐arm, parallel intervention for 12 weeks followed by a prospective single‐arm 4‐year trial in a University Hospital clinic. One hundred patients, >18 years old and with a body mass index > 25 and ≤ 40 kg/m², were prescribed a 1200 to 1500 kcal/d control diet (Group A) or an isoenergetic diet, including two meal and snack replacements (vitamin‐ and mineral‐fortified shakes, soups, and bars) and one meal high in fruits and vegetables (Group B). Following a 3 months of weight loss, all patients were prescribed the same energy‐restricted diet (1200 to 1500 kcal) with one meal and one snack replacement for an additional 4 years. Results: All 100 patients were evaluated at 12 weeks. Mean percentage weight loss was 1.5 ± 0.4% and 7.8 ± 0.5% (mean ± SEM) for Groups A and B, respectively. At 12 weeks systolic blood pressure, plasma triacylglycerol, glucose, and insulin concentrations were significantly reduced in Group B, whereas no changes occurred in Group A. After 4 years, 75% of the patients were evaluated. Total mean weight loss was 3.2 ± 0.8% for Group A and 8.4 ± 0.8% (mean ± SEM) for Group B. Both groups showed significant improvement in blood glucose and insulin (p < 0.001), but only Group B showed significant improvement in triacylglycerol and systolic blood pressure compared to baseline values (p < 0.001). Discussion: Providing a structured meal plan via vitamin‐ and mineral‐fortified liquid meal replacements is a safe and effective dietary strategy for obese patients. Long‐term maintenance of weight loss with meal replacements can improve certain biomarkers of disease risk.     

Effect of Peer Health Workers on AIDS Care in Rakai,Uganda: A Cluster-Randomized Trial

Background

Human resource limitations are a challenge to the delivery of antiretroviral therapy (ART) in low-resource settings. We conducted a cluster randomized trial to assess the effect of community-based peer health workers (PHW) on AIDS care of adults in Rakai, Uganda.

Methodology/Principal Findings

15 AIDS clinics were randomized 2∶1 to receive the PHW intervention (n = 10) or control (n = 5). PHW tasks included clinic and home-based provision of counseling, clinical, adherence to ART, and social support. Primary outcomes were adherence and cumulative risk of virologic failure (>400 copies/mL). Secondary outcomes were virologic failure at each 24 week time point up to 192 weeks of ART. Analysis was by intention to treat. From May 2006 to July 2008, 1336 patients were followed. 444 (33%) of these patients were already on ART at the start of the study. No significant differences were found in lack of adherence (<95% pill count adherence risk ratio [RR] 0.55, 95% confidence interval [CI] 0.23–1.35; <100% adherence RR 1.10, 95% CI 0.94–1.30), cumulative risk of virologic failure (RR 0.81, 95% CI 0.61–1.08) or in shorter-term virologic outcomes (24 week virologic failure RR 0.93, 95% CI 0.65–1.32; 48 week, RR 0.83, 95% CI 0.47–1.48; 72 week, RR 0.81, 95% CI 0.44–1.49). However, virologic failure rates ≥96 weeks into ART were significantly decreased in the intervention arm compared to the control arm (96 week failure RR 0.50, 95% CI 0.31–0.81; 120 week, RR 0.59, 95% CI 0.22–1.60; 144 week, RR 0.39, 95% CI 0.16–0.95; 168 week, RR 0.30, 95% CI 0.097–0.92; 192 week, RR 0.067, 95% CI 0.0065–0.71).

Conclusions/Significance

A PHW intervention was associated with decreased virologic failure rates occurring 96 weeks and longer into ART, but did not affect cumulative risk of virologic failure, adherence measures, or shorter-term virologic outcomes. PHWs may be an effective intervention to sustain long-term ART in low-resource settings.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00675389","term_id":"NCT00675389"}}NCT00675389