Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. Preliminary trial of the effect of general practice based nutritional advice. Controlled studies of nutritional intake in patients with malignant disease undergoing treatment. A cluster randomised trial to evaluate a nutrition training programme. Cognitive therapy, nutritional therapy and their combination in the treatment of bulimia nervosa. Is low salt dietary advice a useful therapy in hypertensive patients with poorly controlled blood pressure? Prospective randomized two-years clinical study comparing additional metformin treatment with reducing diet in type 2 diabetes. A randomized prospective trial comparing a defined formula diet, corticosteroids, and a defined formula diet plus corticosteroids in active Crohn's disease.
Current public health policy recommends weight loss for obese individuals, and encourages energy-restricted diets. Others advocate an alternative, 'non-diet' approach which emphasizes eating in response to physiological cues (eg hunger and satiety) and enhancing body acceptance.
                To evaluate the effects of a 'health-centered' non-diet wellness program, and to compare this program to a traditional 'weight loss-centered' diet program.
                Six-month, randomized clinical trial.
                Free-living, general community.
                Obese, Caucasian, female, chronic dieters, ages 30-45 y (n=78).
                Six months of weekly group intervention in a non-diet wellness program or a traditional diet program, followed by 6 months of monthly after-care group support.
                Anthropometry (weight, body mass index); metabolic fitness (blood pressure, blood lipids); energy expenditure; eating behavior (restraint, eating disorder pathology); psychology (self-esteem, depression, body image); attrition and attendance; and participant evaluations of treatment helpfulness. Measures obtained at baseline, 3 months, 6 months and 1 y.
                (1 y after program initiation): Cognitive restraint increased in the diet group and decreased in the non-diet group. Both groups demonstrated significant improvement in many metabolic fitness, psychological and eating behavior variables. There was high attrition in the diet group (41%), compared to 8% in the non-diet group. Weight significantly decreased in the diet group (5.9+/-6.3 kg) while there was no significant change in the non-diet group (-0.1+/-4.8 kg).
                Over a 1 y period, a diet approach results in weight loss for those who complete the intervention, while a non-diet approach does not. However, a non-diet approach can produce similar improvements in metabolic fitness, psychology and eating behavior, while at the same time effectively minimizing the attrition common in diet programs. To investigate the impact of dietary counseling or nutritional supplements on outcomes in cancer patients: nutritional, morbidity, and quality of life (QoL) during and 3 months after radiotherapy.
                A total of 111 colorectal cancer outpatients referred for radiotherapy, stratified by staging, were randomly assigned: group 1 (G1; n = 37), dietary counseling (regular foods); group 2 (G2; n = 37), protein supplements; and group 3 (G3; n = 37), ad libitum intake. Nutritional intake (diet history), status (Ottery's Subjective Global Assessment), and QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were evaluated at baseline, at the end, and 3 months after radiotherapy.
                At radiotherapy completion, energy intake increased in G1/G2 (P < or = .04), G1 more than G2 (P = .001), and decreased in G3 (P < .01). Protein intake increased in G1/G2 (P < or = .007), G1 less than G2 (not significant), and decreased in G3 (P < .01). At 3 months, G1 maintained nutritional intake and G2/G3 returned to baseline. After radiotherapy and at 3 months, rates of anorexia, nausea, vomiting, and diarrhea were higher in G3 (P < .05). At radiotherapy completion, in G1 all QoL function scores improved proportionally to adequate intake or nutritional status (P < .05); whereas in G2 only three of six function scores improved proportionally to protein intake (P = .04), and in G3 all scores worsened (P < .05). At 3 months, G1 patients maintained/improved function, symptoms, and single-item scores (P < .02); in G2, only few function and symptom scales improved (P < .05); in G3, QoL remained as poor as after radiotherapy. In G1/G2, respectively, improvement/deterioration of QoL correlated with better or poorer intake or nutritional status (P < .003).
                During radiotherapy, both interventions positively influenced outcomes; dietary counseling was of similar or higher benefit, whereas even 3 months after RT, it was the only method to sustain a significant impact on patient outcomes. Despite formal recommendations for dietary change to reduce the incidence of ischaemic heart disease, the acceptability and effectiveness of the proposed diets have not been well investigated in population based studies. In this preliminary investigation of nutritional advice in a well population, subjects in one group practice were randomized to receive either dietary instruction or simple follow up without instruction. The dietary recommendations were well received, and a substantial proportion of subjects reported altering their diets in accordance with them. There were modest beneficial changes in plasma lipid levels among men. Thus, using general practice as an avenue for promoting dietary change is feasible, and may be effective among men. Ninety-seven patients with cancer, undergoing radiation treatment, were studied. Forty-two were given special dietary counseling and supplements of Sustagen or Isocal; 42 controls received no special advice or supplements. Thirteen patients were excluded because of poor prognoses and the ethical need for food supplements. Nutrient intake of all groups was assessed by 3-d diet records in household measures in the first and the last week of treatment. Intake was significantly higher in the adjunctive than the control group. The excluded group, despite supplementation, had intakes similar to the control group. No difference was observed between the control and adjunctive groups in clinical status at the end of treatment or in long-term outcome. The need for training to equip primary care staff with the knowledge and skills to provide dietary advice to the public has been acknowledged. Little is known about the effectiveness of such training at improving the dietary counselling skills of multidisciplinary practice teams.
                To evaluate the effectiveness of a nutrition training programme, delivered to primary care teams by a dietitian.
                A paired-cluster randomised trial.
                Twelve general practices in Sunderland, in the United Kingdom.
                A nutrition training programme, aimed at improving the quality of dietary consultations, was developed and delivered to six primary care teams by a dietitian. Main outcome measures were patients' recall of seven key consulting behaviours. Data were collected from patients in intervention and control practices, pre- and post-intervention. Change in knowledge and attitude of practitioners was also measured.
                All 12 practices completed the trial. Data were collected from 251 patients pre-intervention and 228 patients post-intervention. Of the seven consulting behaviours targeted in the training, only the proportion of consultations where written information (diet sheets) was provided to patients was significantly higher (13% higher, 95% confidence interval [CI = 4 to 21, P = 0.004) in the intervention practices post-training. Some evidence of improved practitioner knowledge and attitude was detected.
                This evaluation of a nutrition training intervention detected only a limited impact on the behaviour, knowledge, and attitudes of primary care practitioners in dietary consultations. This study compared the effectiveness of cognitive therapy (CT), nutritional therapy (NT), the combination of cognitive and nutritional therapy (CNT), against a control condition of support group (SG) in the treatment of bulimia nervosa.
                One hundred female out-patients who fulfilled DSM-III-R criteria for bulimia nervosa were randomized to the four treatment groups. NT and CT were designed to cover different areas with minimal overlap, and CNT provided all of the features of both of these treatments. The control condition was conducted in a group self-help format. Each of the treatments lasted 14 weeks.
                All three active treatments as well as SG produced significant decreases in binge/vomit episodes. Intent-to-treat analysis found CNT and CT to be significantly more effective than SG in retaining subjects in treatment and completion of study, as well as in producing greater improvements in dysfunctional attitudes and self-control. CNT was superior to SG in achieving abstinence from bulimic behaviour. NT was superior to SG only in increase of self-control. Logistic regression found that the cognitive component, whether given alone or in conjunction with NT, and higher pre-treatment self-control scores were significant predictors for both completion of study and abstinence.
                CT (either alone, or in combination with nutritional therapy) remains the treatment of choice for bulimia nervosa. A treatment escalation approach should be tested for the treatment of bulimia with the more intensive and less widely available CT (with or without nutritional counselling) offered after patients have failed the less intensive and more widely available support group treatment. In order to decide whether or not to advise a low Na trial routinely in a hypertension clinic, a randomised controlled 'management' trial was conducted to assess dietary compliance, well-being and changes in antihypertensive medication as a result of such a diet. Sixty-five out-patients on drug treatment for hypertension but with diastolic blood pressures greater than 95 mm Hg on two successive occasions were randomly allocated either to an index group on a 1 g Na (44 mmol) daily diet or to a reference group. Dietary advice was given in detail and repeated as necessary to ensure there was no misunderstanding. After three months 28% of the index group still added salt to their cooking and 13% sometimes added salt at the table. The difference between the groups in 24-hour Na excretion averaged 59 mmol at the end of the trial but 55% of the index group had a 24-hour Na excretion greater than 80 mmol. The average blood pressure at the end of the trial was only a 4 mm Hg systolic and 3 mm Hg diastolic lower in the index group. However, this modest benefit was achieved without any obvious deterioration in the quality of the lives of the patients on the low Na diet. The index group enjoyed their food as much as before and tended to require less drug treatment. On the debit side the index group complained more of transient unsteadiness (p less than 0.05) suggestive of postural hypotension. Low salt dietary advice is only marginally effective in patients poorly controlled on drug treatment. Non-compliance limits the usefulness of the advice. After a 2 weeks hospital treatment with a strong dietary regime 100 patients not sufficiently controlled (blood glucose fasting 120-180, pp 180-250 mg/100 ml), were randomly allocated to a purely dietary therapy or to a diet-metformin-combination for a duration of 2 years. After 1 and 2 years the patients were rehospitalized for an accurate evaluation. Additionally, HbA1 was controlled every 3 months, in case of problems after shorter periods. If HbA1 exceeded 10% for more than 4 weeks the patients were hospitalized for 5 days in order to decide whether the deterioration of metabolic control was due to the patients' non-compliance to treatment or to treatment failure. During 2 years of observation 30 patients were withdrawn from the treatment for external reasons. 13 patients (6 diet, 7 metformin + diet) were non-compliant with diet, 3 further patients were not metformin-compliant. Therapeutic failures were confirmed in 4 diet patients, none of the metformin + diet patients failed to respond to treatment. After excluding all these patients there was a group of 29 diet and 25 metformin + diet patients with a similar development of criteria of metabolic control during 2 years. Lipid levels deteriorated in the dietary group more noticeably than during additional metformin treatment although without reaching a statistically significant level, though. The stimulated C-peptide was significantly reduced by metformin in comparison to diet only, which supports former findings of an insulin-lowering effect of the drug. Although defined formula diets may be useful for initial episodes of Crohn's disease, the effects of these diets on subsequent attacks of Crohn's disease or in conjunction with corticosteroids are unknown. To evaluate these issues, we studied 27 patients in a randomized prospective trial. Ten patients received only prednisone (group I), nine received only a defined formula diet (Vital HN [high nitrogen]) (group II), and eight received a combination of prednisone and Vital HN (group III). At the time of entry into the study, the groups were similar with respect to age, sex, Crohn's Disease Activity Index, previous and current treatments, anatomic site of disease, and nutritional status. After 1 month of treatment, we noted seven successes (70%) and three failures in group I (prednisone only), three successes (33%) and six failures in group II (Vital HN only), and six successes (75%) and two failures in group III (combination therapy). Four patients randomized to receive only Vital HN were unable or unwilling to tolerate the defined formula diet. Of the five patients who were able to take the defined formula diet for 1 month, however, three (60%) were successfully treated. The patients who received prednisone (groups I and III) responded better than did the patients who received only the defined formula diet. These results may be attributable to the use of a nonelemental diet or the treatment of patients who were not experiencing an initial attack of Crohn's disease or who had previously received corticosteroids. The expensive and often poorly tolerated defined formula diets should not be considered as a substitute for standard therapy with corticosteroids in Crohn's disease.
No specific approach can be recommended from this review. It is unclear why 'treatment as usual' performed so poorly, or why dietary advice alone appeared so unacceptable, as the reasons for non-completion were not reported. There is an urgent need for large well-designed trials in this area.