Randomised controlled trial and economic analysis of an internet-based weight management programme: POWeR+ (Positive Online Weight Reduction).

BACKGROUND: Behavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed. OBJECTIVES: To estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice. DESIGN: Individually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews. SETTING: Primary care general practices in the UK. PARTICIPANTS: Patients with a body mass index of ≥ 30 kg/m2 (or ≥ 28 kg/m2 with risk factors) identified from general practice records, recruited by postal invitation. INTERVENTIONS: Positive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls). MAIN OUTCOME MEASURES: The primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months. RESULTS: A total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81%; control, n = 227; POWeR+F, n = 221; POWeR+R, n = 218). The control group maintained nearly 3 kg of weight loss per person (mean weight per person: baseline, 104.4 kg; 6 months, 101.9 kg; 12 months, 101.7 kg). Compared with the control group, the estimated additional weight reduction with POWeR+F was 1.5 kg [95% confidence interval (CI) 0.6 to 2.4 kg; p = 0.001] and with POWeR+R was 1.3 kg (95% CI 0.34 to 2.2 kg; p = 0.007). By 12 months the mean weight loss was not statistically significantly different between groups, but 20.8% of control participants, 29.2% of POWeR+F participants (risk ratio 1.56, 95% CI 0.96 to 2.51; p = 0.070) and 32.4% of POWeR+R participants (risk ratio 1.82, 95% CI 1.31 to 2.74; p = 0.004) maintained a clinically significant 5% weight reduction. The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [control, 47.1% (64/136); POWeR+F, 37.2% (51/137); POWeR+R, 26.7% (40/150)]. The incremental cost to the health service per kilogram weight lost, compared with the control group, was £18 (95% CI -£129 to £195) for POWeR+F and -£25 (95% CI -£268 to £157) for POWeR+R. The probability of being cost-effective at a threshold of £100 per kilogram was 88% and 98% for POWeR+F and POWeR+R, respectively. POWeR+R was dominant compared with the control group. No harms were reported and participants using POWeR+ felt more enabled in managing their weight. The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+. STUDY LIMITATIONS: Maintenance of weight loss after 1 year is unknown. FUTURE WORK: Identifying strategies for longer-term engagement, impact in community settings and increasing physical activity. CONCLUSION: Clinically valuable weight loss (> 5%) is maintained in 20% of individuals using novel written materials with brief follow-up. A web-based behavioural programme and brief support results in greater mean weight loss and 10% more participants maintain valuable weight loss; it achieves greater enablement and fewer participants undertaking other weight-loss activities; and it is likely to be cost-effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21244703. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 4. See the NIHR Journals Library website for further project information.

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

BACKGROUND: The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. METHODS: We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. FINDINGS: Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. INTERPRETATION: Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. FUNDING: Health Technology Assessment Programme of the National Institute for Health Research.

Prospective food diaries demonstrate breastfeeding characteristics in a UK birth cohort.

Breastfeeding duration and exclusive breastfeeding rates are universally below those recommended by World Health Organization. Due to limitations and challenges associated with researching breastfeeding characteristics, the times when exclusivity is likely to be lost and when women are most likely to discontinue breastfeeding have not yet been identified. Prospective food diaries allow reliable description of the dynamics of breastfeeding to be made to help identify these key time periods. Food diaries detailing intake from birth until the cessation of breastfeeding were analysed for 718 infants recruited into a national arm of an international multicentre birth cohort study (EuroPrevall). Analyses included linear regression analysis and Kaplan-Meier time course analysis. Breastfeeding and exclusive breastfeeding cessation rates for younger mothers (<25 years) are high in the first few weeks after delivery but slow markedly in the period 10-12 weeks after delivery. Cessation rates are consistent from 0 to 26 weeks in older mothers. This difference in feeding patterns led to significant differences between the two different age groups at 26 weeks for breastfeeding (P = 0.006) and exclusive breastfeeding at 8 weeks (P = 0.009). Forty-nine per cent of younger mothers (<25 years) stopped breastfeeding before their infant was 3 weeks old. To increase breastfeeding duration, further work is required to investigate the attitudes and perceptions associated with such high breastfeeding cessation rates in younger mothers during these very early post-natal weeks.

Effects of a food-based intervention on markers of micronutrient status among Indian women of low socio-economic status.

Intakes of micronutrient-rich foods are low among Indian women of reproductive age. We investigated whether consumption of a food-based micronutrient-rich snack increased markers of blood micronutrient concentrations when compared with a control snack. Non-pregnant women (n 222) aged 14-35 years living in a Mumbai slum were randomised to receive a treatment snack (containing green leafy vegetables, dried fruit and whole milk powder), or a control snack containing foods of low micronutrient content such as wheat flour, potato and tapioca. The snacks were consumed under observation 6 d per week for 12 weeks, compliance was recorded, and blood was collected at 0 and 12 weeks. Food-frequency data were collected at both time points. Compliance (defined as the proportion of women who consumed ≥ 3 snacks/week) was >85 % in both groups. We assessed the effects of group allocation on 12-week nutrient concentrations using ANCOVA models with respective 0-week concentrations, BMI, compliance, standard of living, fruit and green leafy vegetable consumption and use of synthetic nutrients as covariates. The treatment snack significantly increased ß-carotene concentrations (treatment effect: 47·1 nmol/l, 95 % CI 6·5, 87·7). There was no effect of group allocation on concentrations of ferritin, retinol, ascorbate, folate or vitamin B12. The present study shows that locally sourced foods can be made into acceptable snacks that may increase serum ß-carotene concentrations among women of reproductive age. However, no increase in circulating concentrations of the other nutrients measured was observed.

Improving women's diet quality preconceptionally and during gestation: effects on birth weight and prevalence of low birth weight--a randomized controlled efficacy trial in India (Mumbai Maternal Nutrition Project).

BACKGROUND: Low birth weight (LBW) is an important public health problem in undernourished populations. OBJECTIVE: We tested whether improving women's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population. DESIGN: The study was a nonblinded, individually randomized controlled trial. The intervention was a daily snack made from green leafy vegetables, fruit, and milk (treatment group) or low-micronutrient vegetables (potato and onion) (control group) from ≥ 90 d before pregnancy until delivery in addition to the usual diet. Treatment snacks contained 0.69 MJ of energy (controls: 0.37 MJ) and 10-23% of WHO Reference Nutrient Intakes of ß-carotene, riboflavin, folate, vitamin B-12, calcium, and iron (controls: 0-7%). The primary outcome was birth weight. RESULTS: Of 6513 women randomly assigned, 2291 women became pregnant, 1962 women delivered live singleton newborns, and 1360 newborns were measured. In an intention-to-treat analysis, there was no overall increase in birth weight in the treatment group (+26 g; 95% CI: -15, 68 g; P = 0.22). There was an interaction (P < 0.001) between the allocation group and maternal prepregnant body mass index (BMI; in kg/m(2)) [birth-weight effect: -23, +34, and +96 g in lowest (<18.6), middle (18.6-21.8), and highest (>21.8) thirds of BMI, respectively]. In 1094 newborns whose mothers started supplementation ≥ 90 d before pregnancy (per-protocol analysis), birth weight was higher in the treatment group (+48 g; 95% CI: 1, 96 g; P = 0.046). Again, the effect increased with maternal BMI (-8, +79, and +113 g; P-interaction = 0.001). There were similar results for LBW (intention-to-treat OR: 0.83; 95% CI: 0.66, 1.05; P = 0.10; per-protocol OR = 0.76; 95% CI: 0.59, 0.98; P = 0.03) but no effect on gestational age in either analysis. CONCLUSIONS: A daily snack providing additional green leafy vegetables, fruit, and milk before conception and throughout pregnancy had no overall effect on birth weight. Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented ≥ 3 mo before conception and was not underweight. This trial was registered at www.controlled-trials.com/isrctn/ as ISRCTN62811278.

Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care.

BACKGROUND: There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. METHODS: This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. RESULTS: All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. CONCLUSIONS: This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN31685626.

Diet patterns are associated with demographic factors and nutritional status in South Indian children.

The burden of non-communicable chronic disease (NCD) in India is increasing. Diet and body composition 'track' from childhood into adult life and contribute to the development of risk factors for NCD. Little is known about the diet patterns of Indian children. We aimed to identify diet patterns and study associations with body composition and socio-demographic factors in the Mysore Parthenon Study cohort. We collected anthropometric and demographic data from children aged 9.5 years (n = 538). We also administered a food frequency questionnaire and measured fasting blood concentrations of folate and vitamin B12. Using principal component analysis, we identified two diet patterns. The 'snack and fruit' pattern was characterised by frequent intakes of snacks, fruit, sweetened drinks, rice and meat dishes and leavened breads. The 'lacto-vegetarian' pattern was characterised by frequent intakes of finger millet, vegetarian rice dishes, yoghurt, vegetable dishes and infrequent meat consumption. Adherence to the 'snack and fruit' pattern was associated with season, being Muslim and urban dwelling. Adherence to the lacto-vegetarian pattern was associated with being Hindu, rural dwelling and a lower maternal body mass index. The 'snack and fruit' pattern was negatively associated with the child's adiposity. The lacto-vegetarian pattern was positively associated with blood folate concentration and negatively with vitamin B12 concentration. This study provides new information on correlates of diet patterns in Indian children and how diet relates to nutritional status. Follow-up of these children will be important to determine the role of these differences in diet in the development of risk factors for NCD including body composition.

The nutrition transition in Africa: can it be steered into a more positive direction?

The objective of this narrative review is to examine the nutrition transition and its consequences when populations in Africa modernize as a result of socio-economic development, urbanization, and acculturation. The focus is on the changes in dietary patterns and nutrient intakes during the nutrition transition, the determinants and consequences of these changes as well as possible new approaches in public health nutrition policies, interventions and research needed to steer the nutrition transition into a more positive direction in Africa. The review indicates that non-communicable, nutrition-related diseases have emerged in sub-Saharan Africa at a faster rate and at a lower economic level than in industrialized countries, before the battle against under-nutrition has been won. There is a putative epigenetic link between under- and over-nutrition, explaining the double burden of nutrition-related diseases in Africa. It is concluded that it is possible to steer the nutrition transition into a more positive direction, provided that some basic principles in planning public health promotion strategies, policies and interventions are followed. It is suggested that sub-Saharan African countries join forces to study the nutrition transition and implemented interventions on epidemiological, clinical and molecular (genetic) level for better prevention of both under- and over-nutrition.

The nutrition and health transition in the North West Province of South Africa: a review of the THUSA (Transition and Health during Urbanisation of South Africans) study.

OBJECTIVE: To describe how urbanisation influences the nutrition and health transition in South Africa by using data from the THUSA (Transition and Health during Urbanisation of South Africans) study. DESIGN: The THUSA study was a cross-sectional, comparative, population-based survey. SETTING: The North West Province of South Africa. SUBJECTS: In total, 1854 apparently healthy volunteers, men and women aged 15 years and older, from 37 randomly selected sites. Pregnant and lactating women, those with diagnosed chronic diseases and taking medication, with acute infections or inebriated were excluded but screened for hypertension and diabetes mellitus. Subjects were stratified into five groups representing different levels of urbanisation in rural and urban areas: namely, deep rural, farms, squatter camps, townships and towns/cities. OUTCOME MEASURES AND METHODS: Socio-economic and education profiles, dietary patterns, nutrient intakes, anthropometric and biochemical nutrition status, physical and mental health indicators, and risk factors for non-communicable diseases (NCDs) were measured using questionnaires developed or adapted and validated for this population, as well as appropriate, standardised methods for the biochemical analyses of biological samples. RESULTS: Subjects from the rural groups had lower household incomes, less formal education, were shorter and had lower body mass indices than those in the urban groups. Urban subjects consumed less maize porridge but more fruits, vegetables, animal-derived foods and fats and oils than rural subjects. Comparing women from rural group 1 with the urban group 5, the following shifts in nutrient intakes were observed: % energy from carbohydrates, 67.4 to 57.3; from fats, 23.6 to 31.8; from protein, 11.4 to 13.4 (with an increase in animal protein from 22.2 to 42.6 g day(-1)); dietary fibre, 15.8 to 17.7 g day(-1); calcium, 348 to 512 mg day(-1); iron from 8.4 to 10.4 mg day(-1); vitamin A from 573 to 1246 mug retinol equivalents day(-1); and ascorbic acid from 30 to 83 mg day(-1). Serum total cholesterol, low-density lipoprotein cholesterol and plasma fibrinogen increased significantly across groups; systolic blood pressure >140 mmHg was observed in 10.4-34.8% of subjects in different groups and diabetes mellitus in 0.8-6.0% of subjects. Women in groups 1 to 5 had overweight plus obesity rates of 48, 53, 47, 61 and 61%, showing an increase with urbanisation. Subjects from group 2 (farm dwellers) showed the highest scores of psychopathology and the lowest scores of psychological well-being. The same subjects consistently showed the lowest nutrition status. CONCLUSIONS: Urbanisation of Africans in the North West Province is accompanied by an improvement in micronutrient intakes and status, but also by increases in overweight, obesity and several risk factors for NCDs. It is recommended that intervention programmes to promote nutritional health should aim to improve micronutrient status further without leading to obesity. The role of psychological strengths in preventing the adverse effects of urbanisation on health needs to be examined in more detail.